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The Senior Manager/Associate Director, Regulatory Writing will serve as the lead regulatory writing professional across Angitia''s development portfolio and will be responsible for planning, authoring, coordinating, and delivering high-quality regulatory documents supporting global development programs from IND through marketing application and lifecycle management activities. This individual will provide strategic document leadership, working closely with Regulatory Affairs, Clinical Development, Biometrics, Safety, Nonclinical, CMC, and external partners to develop clear, scientifically rigorous, and submission-ready documentation.

YEAR

Angitia Biopharmaceuticals Ltd

Sr. Manager/Associate Director, Regulatory Writer

The GMSLE Director collaborates closely with Global Medical Affairs, Global Clinical Operations, Global Medical Excellence, Strategy and Operations (MESO), in-market Field Medical leadership and other cross-functional partners to ensure Field Medical strategy and MSL effort allocation aligns with Global tumour area priorities and Local needs. Clinical trial operations: Lead the collaboration with Global Clinical Operations, Global Medical Affairs and Local Markets for Field Medical support of AstraZeneca's clinical development program - embedding study prioritisation governance, communicating clear expectations for Field Medical support and proactively addressing Global/Local challenges to facilitate the effective delivery of our trials with measurable impact.

AstraZeneca is one of the world’s most exciting bio-pharmaceutical companies. From scientists to sales, lab techs to legal, we’re on a mission to turn ideas into life-changing medicines that improve patients’ lives and benefit society. We need great people who share our passion for science and have the drive and determination to meet the unmet needs of patients around the world.

AstraZeneca Plc

Global MSL Excellence Director

As a Medical Director at ICON, you will drive medical initiatives within project teams, guiding strategic direction and decision-making processes, and offer expert medical and scientific guidance, leveraging therapeutic expertise to inform project development. Medical Director (Neurology)- United States- Remote ICON is a global healthcare intelligence and clinical research organisation united by a mission to bring new medicines and treatments to patients faster.

Medical Director (Neurology)

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Reporting to the Vice President for Research and Economic Development, the Director leads F-1 and J-1 student and scholar support and compliance, Study Abroad, English as a Second Language (ESL), the International Visitors Center of Jackson, international exchanges, and related global programming. Identify opportunities to translate international visits into sustained educational, cultural, workforce, academic, or other institutional collaborations; coordinate executive-level engagements with the Vice President.

Jackson State University

Director for JSU Global/International Programs

OTHER

Acadia Healthcare's Comprehensive Treatment Centers (CTC) division operates 170+ CARF-accredited outpatient opioid treatment programs (OTPs) nationwide, serving patients undergoing treatment for opioid use disorder (OUD). Allentown Comprehensive Treatment Center (CTC) , located in Orefield, PA , is part of Acadia Healthcare’s nationwide network of Comprehensive Treatment Centers—the leading provider of medication-assisted treatment (MAT) for opioid use disorder (OUD).

Allentown Comprehensive Treatment Center

Clinic Director

[AW]-iCims

Acadia Healthcare's Comprehensive Treatment Centers (CTC) division operates 170+ CARF-accredited outpatient opioid treatment programs (OTPs) nationwide, serving patients undergoing treatment for opioid use disorder (OUD). Demonstrated business development experience is highly preferred, including generating patient referral sources and building strong relationships with community partners, stakeholders, and local entities such as law enforcement, healthcare providers, and advocacy organizations.

Duncansville Comprehensive Treatment Center

Overseeing the Clinical Supply Management (CSM) team, the Associate Director interprets complex clinical protocols, development plans and commercial demand forecasts, working with CMC and internal and external partners to develop packaging, labelling, supply and resupply strategies, timelines and plans. The role partners closely with Clinical Operations, Commercial, CMC, Quality, Regulatory, Finance, Legal, Procurement, Medical Affairs and Program Management, and oversees external partners including Contract Development and Manufacturing Organizations (CDMOs), IXRS providers and specialist service providers.

Summit Therapeutics plc

Associate Director, Clinical Supply Management

Our industry-leading neuroscience portfolio includes FDA-approved treatments for major depressive disorder, agitation associated with dementia due to Alzheimer's disease, excessive daytime sleepiness associated with narcolepsy and obstructive sleep apnea, and migraine, as well as multiple novel product candidates addressing a broad range of serious neurological and psychiatric conditions that impact over 150 million people in the United States. The individual will lead the development of study protocols, statistical analysis plans, and study reports in partnership with the HEOR Lead & Medical Strategy colleagues, oversee programming and execution of analyses inclusive of quality control procedures, and deliver high-quality evidence to inform value demonstration, payer engagement, and scientific publications.

Axsome Therapeutics Inc

Associate Director, HEOR Analytics

Oversee financial aid systems, technology, reporting and data integrity, including PowerFAIDS and applicable federal and state systems; ensure timely and accurate required submissions and reconciliations, appropriate access and configuration, security, testing, documentation and continuous improvement, in partnership with Information Technology and other campus partners. Partner with Admissions, Student Accounts, the Registrar, Finance, Academic Affairs, Information Technology, Institutional Research, the One Stop Center for Enrollment Student Services, Military and Veteran Services and other campus offices to coordinate services, resolve complex student issues and remove financial barriers to enrollment and persistence.

Simmons University

Director of Financial Aid

This includes developing and ensuring execution of the scientific resources and utilization strategies for the medical affairs (MA) team in close collaboration with the MA management team and other internal stakeholders such as Clinical, Medical Information, Marketing, Market Shaping, Sales Operations and CMR Training to assist in the implementation of scientific initiatives focused on both internal and external customers (HS, MM, endocrinology, obesity, primary care providers, etc.). Lead development of resources that help the team engage with external customers: National tools for all field teams to utilize; Customer specific tools for various stakeholders, including specialists primary care providers, health systems, allied health professionals and Managed Care customers; Custom tools and resources to support unanticipated business critical needs.

<h1><strong>Working at Novo Nordisk</strong></h1>
<p> </p>
<h3><strong>Life-changing careers</strong></h3>
<p>Starting a career at Novo Nordisk is more than getting a job. It is an opportunity to improve the lives of millions of people living with a serious chronic disease.</p>
<p>Whether you are a part of supplying insulin for patients around the world, discovering the next breakthrough at one of our state-of-the-art research centres, working with us is truly life-changing.</p>
<p> </p>
<h3><strong>We are inspired by life</strong></h3>
<p>We are a proud life-science company on a mission to ensure that people living with a chronic disease can live a full life. Millions rely on us.</p>
<p>We’re inspired by life in all its forms and shapes, ups and downs, opportunities and challenges. From our colleagues in the lab, working to change lives through pioneering break-through treatments, to our colleagues putting sustainability at the core of our processes and working to prolong the life of our planet, this mission to improve lives is at the core of our every action.</p>
<p> </p>
<h3><strong>Together we drive change</strong></h3>
<p>Change is a constant — change in lifestyle, change in technology, change all over. At Novo Nordisk, we don’t wait for change. We drive it.</p>
<p>We’re a dynamic company in an even more dynamic industry, and we know that what got us to where we are today is not necessarily what will make us successful in the future.</p>
<p>That’s why we continuously push to improve the way we work and the lives of the patients we serve, creating innovative solutions that fit the way people want to live. To accomplish this, we embrace a spirit of open-mindedness and experimentation, striving for excellence without fixating on perfection.</p>
<p> </p>
<h3><strong>Together, we are life-changing</strong></h3>
<p>Our company is our people. We know that life is anything but linear and balancing what is important at different stages of our career is never easy. That’s why we make room for diverse life situations, always putting people first. We want to ensure that every employee can achieve a work-life balance that supports their current priorities and where they want to go next.</p>
<p> </p>
<h3><strong>Your development starts here</strong></h3>
<p>We value our employees for the unique skills, backgrounds and perspectives they bring to the table. We work continuously to help bring out the best in all of our people, offering opportunities for development and creating an environment of mobility within the company. We strive to offer a workplace that’s great to be in and to be from.</p>
<p>It is very important to us that anyone working with us feels empowered as an employee and as a person. We all should have the opportunity to act fast, make decisions and be agile. </p>
<p>With a career at our company, you will feel a difference right from the start. A sense of inspiration that comes from a shared belief in driving positive change for people, families and communities everywhere, and it’s a collective effort. We rely on the joint potential and collaboration of our more than 45,000 employees.</p>
<p>In the video above, meet  Marie Darting, one of our scientists, and hear more about her work as a formulation scientist, her perspective on development plans and the impact she feels her work has on people living with a chronic disease.</p>
<p> </p>
<h3><strong>Who we are</strong></h3>
<p>We were founded in 1923 and today we are a global healthcare company headquartered just outside Copenhagen, Denmark.</p>
<p>Our purpose is to drive change to defeat diabetes and other serious chronic diseases, such as obesity and rare blood and endocrine disorders. We do so by pioneering  scientific breakthroughs, expanding  <a href="https://www.novonordisk.com/sustainable-business/access-and-affordability.html">access to our medicines</a> , and working to <a href="https://www.novonordisk.com/sustainable-business/preventing-chronic-diseases.html">prevent</a> and <a href="https://www.novonordisk.com/disease-areas/type-1-diabetes.html">ultimately cure diabetes</a>.</p>
<p>With almost 100 years of experience, one of the broadest diabetes product portfolios in the healthcare industry, as well as an award-winning pipeline of innovative products, our success is built on our company values – <span style="text-decoration: underline"><a href="https://www.novonordisk.com/about/who-we-are.html">the Novo Nordisk Way.</a></span></p>

Novo Nordisk

Program Development & Training Director

The Executive Director, Urology Services, leads Elliot Health Systems (EHS) Urology service line across multiple sites, with responsibilities inclusive of the development and implementation of system-level strategic plans, policies and procedures, and provision of overall administrative direction and coordination for the Urology, Urogynecology and Urologic Oncology Services across multiple practice sites (“Urology Services”). The Executive Director will have matrix reporting to The Chief Physician Executive & SVP of Medical Affairs, and The Chief Nurse Executive & SVP and a dyad leadership model working in collaboration with the Executive Medical Director of Urology Services.

SolutionHealth

Executive Director - Urology Services - Full Time

This role addresses the intersection of medical affairs, field execution, and scientific credibility - driving engagement with community oncologists, KOLs, and cross-functional field teams to accelerate appropriate utilization of Natera''s oncology portfolio, including Signatera and Altera. The Natera team consists of highly dedicated statisticians, geneticists, doctors, laboratory scientists, business professionals, software engineers and many other professionals from world-class institutions, who care deeply for our work and each other.

Natera Inc

Area Medical Director - Oncology

Serve as a thought leader on regulatory affairs, defining regulatory strategy and plan to maximize regulatory success in our next generation anti-myostatin therapy and US regulatory representative for new indication for an approved product. Scholar Rock is delivering muscle-targeted breakthroughs to transform the treatment of spinal muscular atrophy (SMA) and other rare neuromuscular diseases where muscle atrophy remains a critical unmet need.

Scholar Rock

Associate Director, Regulatory Strategy

The role also includes oversight of medical information responses (in collaboration with Medical Information), scientific communications (including publications and congress presentations in partnership with the Publication team), and the design and medical oversight of US based clinical studies, as well as the review and approval of promotional and medical materials and educational grants. Develop and maintain relationships with key opinion leaders and external stakeholders to gather insights and inform medical strategy, while supporting external scientific collaboration strategies to address educational gaps and advance scientific understanding of Ipsen assets.

ImCheck Therapeutics SAS

Director, Medical Affairs Oncology

The Director will serve as a key member of Pfeiffer's enrollment management leadership team and will work closely with Admissions, Student Development, Student Accounts, the Registrar, Finance, academic leadership, and other campus partners to ensure that financial aid supports the University's enrollment, retention, affordability, and student-success objectives. The successful candidate will combine strong technical knowledge of federal and state financial aid regulations with the ability to think strategically about financial aid leveraging, institutional scholarship resources, enrollment goals, student affordability, and net tuition revenue.

Pfeiffer University

Reporting to the Provost and Vice President for Academic Affairs, the Executive Director is responsible for establishing a dynamic academic unit that prepares students for careers in nursing and allied health professions while advancing the Universitys mission of academic excellence, workforce development, and community impact. The Executive Director will lead the strategic development of new academic programs, recruit and support faculty and staff, build partnerships with healthcare organizations, and guide programs through accreditation processes.

Central State University

Executive Director of Allied Health and Nursing

Reporting to the Senior Director of IT Applications, this person will own the technology strategy and execution across the Development portfolio, build trusted partnerships with Clinical Operations, Clinical/Medical Development, Quality, Biometrics, Data Management, Regulatory, and more, and serve as a thought partner to the IT leadership team as Kymera scales. Having advanced the first degrader into the clinic for immunological diseases, Kymera is focused on building an industry-leading pipeline of oral small molecule degraders to provide a new generation of convenient, highly effective therapies for patients with these conditions.

Kymera Therapeutics Inc

IT Director, Development Business Partner

This high-impact role will shape Alumis's expanding clinical portfolio from the ground up, from indication selection and study design through proof-of-concept readout, and will serve as a key scientific leader and external face of the program with investigators, regulatory authorities, and the broader medical community. Experience across multiple therapeutic indications, including neurological diseases (e.g., neurodegenerative diseases, movement disorders) and/or inflammatory conditions such as psoriasis, psoriatic arthritis, lupus, or atopic dermatitis.

Alumis Inc.

Senior/Executive Medical Director, Clinical Development (New Indications)

HARMONi: Phase 3 clinical study which was intended to evaluate ivonescimab combined with chemotherapy compared to placebo plus chemotherapy in patients with EGFR-mutated, locally advanced or metastatic non-squamous NSCLC who were previously treated with a 3rd generation EGFR TKI. Experience, Education and Specialized Knowledge and Skills: Bachelor's degree in Chemistry, Pharmacy, Engineering, Biochemistry, or related scientific discipline required; advanced degree (Master's or PhD) strongly preferred.

Summit Therapeutics Inc

Senior Director, Regulatory CMC

This role will lead evidence generation strategies, provide strategic oversight, and co-lead initiatives including post-marketing Ph3b/Ph4 studies in collaboration with Clinical Sciences & Clinical Development, Investigator Initiated ResearchStudies (IIRs), collaborative research efforts, real-world evidence (RWE) initiatives, outcomes research, and integrated evidence planning activities. HEOR), Clinical Development, Clinical Science, Biostatistics, Regulatory, Market Access, Commercial, and external scientific experts to identify evidence gaps and drive the generation of clinically meaningful, scientifically rigorous, and impactful evidence supporting Celldex programs across the product lifecycle.

Director Of Regulatory Affairs Jobs in the United States

Sr. Manager/Associate Director, Regulatory Writer Angitia Biopharmaceuticals Ltd

Global MSL Excellence Director AstraZeneca Plc

Medical Director (Neurology) IRE

Director for JSU Global/International Programs Jackson State University

Clinic Director Allentown Comprehensive Treatment Center

Clinic Director Duncansville Comprehensive Treatment Center

Associate Director, Clinical Supply Management Summit Therapeutics plc

Associate Director, HEOR Analytics Axsome Therapeutics Inc

Director of Financial Aid Simmons University

Program Development & Training Director Novo Nordisk

Executive Director - Urology Services - Full Time SolutionHealth

Area Medical Director - Oncology Natera Inc

Associate Director, Regulatory Strategy Scholar Rock

Director, Medical Affairs Oncology ImCheck Therapeutics SAS

Director of Financial Aid Pfeiffer University

Executive Director of Allied Health and Nursing Central State University

IT Director, Development Business Partner Kymera Therapeutics Inc

Senior/Executive Medical Director, Clinical Development (New Indications) Alumis Inc.

Senior Director, Regulatory CMC Summit Therapeutics Inc

Sr. Director, Medical Evidence Generation, Immunology - Hampton, NJ Celldex Therapeutics

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