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A well-known large consumer products corporation is hiring for Regulatory Affairs Manager. Responsibilities include: Ensure completion of appropriate documents during the development life cycle and launch .

Workforce Solutions Virens Global

Senior Manager Regulatory Affairs

for more information please go through this link: https://careers.blackhillsenergy.com/jobs/18382018-regulatory-affairs-manager .

Black Hills Corporation has a long and proud history of innovation that began in 1883 with the founding of Black Hill Electric Light Company in Deadwood, South Dakota. More than 125 years later, Black Hills is a diversified energy leader committed to providing affordable energy today and sustainable energy for years to come. We strive to be the energy partner of choice through two major business groups – regulated utilities and non-regulated energy. This vision for our business is achieved through our dedicated employees who live our values both in the field and in the communities we serve.

Black Hills Corp

Regulatory Affairs Manager NEW

A Day in the Life: Based at Monster’s California headquarters in Corona, the Senior Regulatory Affairs Manager is responsible for reviewing ingredients and formulas for compliance and developing accurate and compliant label information for North America and Oceania. Coordinator cross-functional teams, including Creative Services, Innovation, and Project Management, to deliver compliant and market-ready labeling solutions.

Monster Energy

Senior Manager of Regulatory Affairs, NORAM/OCEANIA

Manage and maintain regulatory documentation, product registrations, and regulatory correspondence while serving as the primary liaison with regulatory authorities including FDA, notified bodies, and other agencies to drive product approvals, clearances, and registrations. Author, prepare and submit U.S. and global regulatory filings, including Traditional and Special 510(k)s, Letters to File, Pre-Subs, IDEs, technical documentation for European Union, and related submissions.

YEAR

Do you find pride and purpose in helping millions of people around the world renew their lives? If so, career opportunities at Zimmer facilities worldwide will be an excellent fit for you. We're looking for remarkable people who can be catalysts for change, collaborate globally and push the boundaries of innovation so that we can continue to make the world a more mobile place.
We've found that when you're working to improve others' lives, you start to feel incredibly proud and excited about what you do. Join us and find your fit in a company with passion.

Zimmer Biomet Holdings Inc

Regulatory Affairs Manager

The Senior Regulatory Manager provides CMC regulatory input and strategies to directly support development projects and marketed products within Pharmaceutical Diagnostics. In conjunction with the Global Regulatory Lead (GRL), guide the project team in the project planning phase so that the correct data (and level of detail) to suit the needs of all markets is collected and submitted.

GE HealthCare

Senior Regulatory Affairs Manager, Chemistry Manufacturing and Controls

GE HealthCare Technologies Inc

Manage the activities of the department including leading internal efforts to comply with regulatory requirements affecting the commercial line of business, including rules related to the Affordable Care Act, Mental Health Parity and Addiction Equity Act (MHPAEA), Transparency in Coverage and No Surprises Act, and ERISA. This position serves as a point of contact for federal and state officials and regulators, a resource to commercial employer groups regarding regulatory requirements and benefit changes, and representative to the organization's trade groups regarding commercial regulatory requirements and proposals.

Viva Health, Inc.

Manager, Regulatory Affairs

We are seeking a Manager, CMC Regulatory Affairs- Biologics to join our CMC Regulatory Affairs team, supporting our biologics portfolio in an on-site work model. In this role, you will lead regulatory strategy and regulatory compliance activities across development, submissions, and post-market programs while collaborating with Global Regulatory Affairs and CMC collaborators.

At Regeneron, we believe in the power of original thinking. Our company is built on breakthrough ideas; which is why we foster a spirit of openness, and strive to inspire from within. We are collaborative by design and driven by curiosity. Each one of us plays an active role in transforming people’s lives through our work. Regeneron’s people make us who we are, and we are truly more than a company &ndash; we’re a community. Simply put, we’re a tight-knit group working together to change the world.

Regeneron Pharmaceuticals

Manager CMC Regulatory Affairs

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Regulatory responsibilities also include post-approval drug product reporting activities such as completing regulatory impact assessments for commercial drug product changes, filing labeling and promotional material submissions, supporting adverse event reporting activities and developing appropriate regulatory strategies to support business objectives. Reporting to this Position :No direct reports Travel :Position may require up to 10% travel Work Shift :This position works days, but may include extended hours and weekend work when required Knowledge, Skills and Abilities : Excellent oral and written communication skills.

Aprecia Pharmaceuticals

Manager of Regulatory Affairs

As a part of the Regulatory Affairs team at Azurity, the Regulatory Affairs Manager will be responsible for overseeing and managing the regulatory activities for assigned products/projects and will serve as the regulatory representative on cross-functional teams for assigned projects. As an industry leader in providing unique, accessible, and high-quality medications, Azurity leverages its integrated capabilities and vast partner network to continually expand its broad commercial product portfolio and robust late-stage pipeline.

Azurity Pharmaceuticals - US

Senior Manager, Regulatory Affairs

Brief team/department description: As a part of the Regulatory Affairs team at Azurity, the Regulatory Affairs Manager will be responsible for overseeing and managing the regulatory activities for assigned products/projects and will serve as the regulatory representative on cross-functional teams for assigned projects. As an industry leader in providing unique, accessible, and high-quality medications, Azurity leverages its integrated capabilities and vast partner network to continually expand its broad commercial product portfolio and robust late-stage pipeline.

Azurity Pharmaceuticals Inc

In particular, this role will (a) provide strategic device regulatory decisions on strategies and risk management of the diagnostic device and AI/ML product portfolio throughout the entire product lifecycle, (b) solve unique and strategic challenges with broad impact on the growing diagnostic device portfolio in a dynamic regulatory environment, and (c) establish trusted relationships with industry partners and interface with health authorities with the goal to influence industry best practices and regulatory landscape intentionally. As assigned by management, may support global submission activities (new product development, sustaining products, new/updated features, etc.), regulatory compliance or operation activities (recall, non-conformance, audit, process improvement, country approval, distribution control, annual update, post-market surveillance, regulatory intelligence, labeling, claims, advertising promotional materials, etc.).

Align Technology

Sr. Manager, Regulatory Affairs

PinpointHQ

We add value each step of the way by focusing on the following: People for Build lasting relationships, anchored on common objectives, with key business partners across Finance, Legal, Global Affairs and Public Policy, Engineering, and more. The Regulatory Affairs Finance (RAF) team mitigates Alphabet's risk through robust governance, controls, and structured communication to provide timely, consistent responses to global requests for financial disclosures.

Google LLC

Finance Program Manager, Regulatory Affairs

Given the complexity of New Jersey''s regulatory environment, the frequency and significance of ongoing regulatory proceedings, and the need to protect both customer and shareholder interests, backfilling this position is necessary to maintain continuity of expertise, preserve key stakeholder relationships, support critical business initiatives, and ensure successful execution of JCP&L''s regulatory and financial objectives. We are committed to rewarding individual and team efforts through our total rewards philosophy which includes competitive pay plus incentive compensation, a company-sponsored pension plan, 401 (k) savings plan with matching employer contribution, a choice of medical, prescription drug, dental, vision, and life insurance programs, as well as skills development training with tuition reimbursement.

FirstEnergy Corp

Manager Rates and Regulatory Affairs - NJ Finance & Regulatory

LANXESS has achieved leading positions in the Dow Jones Best-in-Class Index and the MSCI ESG and ISS ESG ratings, among others, for its commitment to sustainability. 5 to 10 years experience in the regulatory field with technical knowledge of the current FIFRA and PMRA regulatory requirements, procedures and guidelines for Registration of biocides by the U.S. EPA, state agencies and PMRA.

Lanxess AG

Teamwork - Balances team and individual responsibilities; Exhibits objectivity and openness to others' views; Gives and welcomes feedback; Contributes to building a positive team spirit; Puts success of team above own interests; Able to build morale and group commitments to goals and objectives; Supports everyone's efforts to succeed. Problem Solving - Identifies and resolves problems in a timely manner; Gathers and analyzes information skillfully; Develops alternative solutions; Works well in group problem solving situations; Uses reason even when dealing with emotional topics.

Azelis

Manager, Product Stewardship & Regulatory Affairs

Job Summary: The Manager of Regulatory Affairs Labeling is responsible for the development, review, and approval of commercial product labeling (Prescribing Information, Patient Information, Medication Guides, and Instructions for Use) and printed component artwork (cartons, container labels, blister foils and pouches) across the assigned Supernus commercial portfolio. This role partners with Clinical Development, Medical Affairs, Commercial, Quality, Technical Operations, Supply Chain, and external graphic and packaging vendors to ensure all labeling and artwork content is accurate and compliant with FDA regulations and ICH guidelines.

Supernus Pharmaceuticals Inc

Manager, Regulatory Affairs Labeling

Supernus

If you are applying to perform work for Medtronic, Inc. ("Medtronic") in any position which will involve performing at least two (2) hours of work on average each week within the unincorporated areas of Los Angeles County, you can find here a list of all material job duties of the specific job position which Medtronic reasonably believes that criminal history may have a direct, adverse and negative relationship potentially resulting in the withdrawal of a conditional offer of employment. The following benefits and additional compensation are available to those regular employees who work 20+ hours per week: Health, Dental and vision insurance, Health Savings Account, Healthcare Flexible Spending Account, Life insurance, Long-term disability leave, Dependent daycare spending account, Tuition assistance/reimbursement, and Simple Steps (global well-being program).

Medtronic Plc

You will be accountable for driving regulatory excellence by aligning cross-functional stakeholders, managing complex timelines, and anticipating challenges to enable successful delivery of regulatory milestones that support sponsor's mission to bring transformative vaccines to patients worldwide. This role is designed for an experienced and forward-thinking regulatory project manager who thrives in a fast-paced, innovative environment and can seamlessly integrate strategic thinking with operational execution across all stages of product development, registration, and post-marketing.

The expertise and passion for excellence shared by our people around the world unites us in our mission and drives our success. As a premier service provider to the global biopharmaceutical industry, we give you the opportunity to work with industry-leading clients in an exciting, collaborative environment where career choices and development paths are abundant, and projects are challenging. In fact, PAREXEL works with the top 50 global pharmaceutical companies, the top global biotech companies, and hundreds of small and emerging companies. With over 30 years of experience, we have supported the development of some of the most important treatments of our time, including nearly all of the 50 top selling drugs currently on the market. We offer our employees the ability to make a difference globally, while we support them locally in environments full of challenge, collaboration, flexibility and industry-leading growth potential. Discover a career at PAREXEL, where exciting challenges and opportunities await you.

Regulatory Affairs Manager Jobs in the United States

Senior Manager Regulatory Affairs Workforce Solutions Virens Global

Regulatory Affairs Manager NEW Black Hills Corp

Senior Manager of Regulatory Affairs, NORAM/OCEANIA Monster Energy

Regulatory Affairs Manager Zimmer Biomet Holdings Inc

Senior Regulatory Affairs Manager, Chemistry Manufacturing and Controls GE HealthCare

Senior Regulatory Affairs Manager, Chemistry Manufacturing and Controls GE HealthCare Technologies Inc

Manager, Regulatory Affairs Viva Health, Inc.

Manager CMC Regulatory Affairs Regeneron Pharmaceuticals

Manager of Regulatory Affairs Aprecia Pharmaceuticals

Senior Manager, Regulatory Affairs Azurity Pharmaceuticals - US

Senior Manager, Regulatory Affairs Azurity Pharmaceuticals Inc

Sr. Manager, Regulatory Affairs Align Technology

Finance Program Manager, Regulatory Affairs Google LLC

Manager Rates and Regulatory Affairs - NJ Finance & Regulatory FirstEnergy Corp

Regulatory Affairs Manager Lanxess AG

Manager, Product Stewardship & Regulatory Affairs Azelis

Manager, Regulatory Affairs Labeling Supernus Pharmaceuticals Inc

Manager, Regulatory Affairs Labeling Supernus

Regulatory Affairs Manager Medtronic Plc

Senior Regulatory Affairs Consultant - Regulatory Project Manager Parexel International Corp

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