Manager, U.S. Regional Regulatory Lead - LCM CSL
Waltham, MA30+ days ago
Highlights
Plan, prepare, and manage regulatory submissions (INDs, amendments, annual reports, briefing packages, and late-stage filings), working with internal teams and external partners. As the company builds its local presence and brings more development activities in-house, it's seeking an experienced regulatory leader to own and run the regulatory function.
Numbers & Facts
| Location | Cambridge, MA |
| Industry | Staffing/Employment Agencies |
| Company Size | 10 to 19 employees |
| Year Founded | 2017 |
| Website | http://www.whitecapsearch.com |
Description
Head of Regulatory Affairs
About the Opportunity
We're partnering with a clinical-stage biotech in Cambridge developing therapies in metabolic and liver disease. As the company builds its local presence and brings more development activities in-house, it's seeking an experienced regulatory leader to own and run the regulatory function.
This is a hands-on leadership role for someone who has worn many hats. You'll bring the discipline of the core regulatory process, the judgment that comes from taking programs through Phase 1 to Phase 3, and the ability to build the function as the company grows.
What You'll Do
- Own and lead the regulatory affairs function, including day-to-day operations, submissions, and agency interactions
- Set and execute regulatory strategy across the clinical portfolio, partnering closely with Clinical, CMC, and executive leadership
- Plan, prepare, and manage regulatory submissions (INDs, amendments, annual reports, briefing packages, and late-stage filings), working with internal teams and external partners
- Serve as the primary point of contact with FDA and other health authorities, leading meeting preparation and communications
- Manage regulatory vendors and CRO partners, and lead the transition of regulatory activities and knowledge in-house
- Support quality and GxP compliance activities as they relate to regulatory submissions and clinical programs
- Build the regulatory SOPs, processes, and infrastructure the function needs as the company scales
- Monitor the regulatory and competitive landscape in metabolic and liver disease and advise leadership on implications
What You Bring
- Bachelor's degree required; advanced degree (MS, PharmD, PhD) preferred
- 10+ years of regulatory affairs experience in biotech/pharma, including leading a regulatory function or group
- Demonstrated experience taking a program through Phase 1, Phase 2, and Phase 3 clinical development
- Direct experience leading FDA interactions and managing CROs and regulatory vendors
- Working knowledge of GxP and quality requirements, with the ability to support quality activities as needed
- Experience in obesity, metabolic, or liver disease is a plus
- Comfortable in a lean, fast-moving environment where you'll be both strategic and hands-on
- Available full-time (40 hours/week)
- Able to be onsite in Cambridge at least 2 days per week
About Company
At WhiteCap Search we are breaking away from the traditional approach of agency recruiting to enhance the experience of the job search process. From companies looking to hire top talent, to job seekers looking for the best next step in their careers, WhiteCap Search is focused on finding the optimal fit for all parties involved.
Founded by a diverse team of recruiting experts, we have developed a strong foundational knowledge of each industry for which we recruit. We believe in combining best in class technology with rigid ethical standards to create a positive and tailored approach for each employer and job seeker.
The WhiteCap Search team is uniquely positioned to handle both permanent and temporary searches for a wide variety of job functions across all industries. We optimize our extensive network and cutting-edge technology to deliver results successfully and seamlessly. Utilizing our strong foundational knowledge of each industry for which we recruit, we engage our clients as partners by creating a customized plan for every search. We source job seekers proactively so that employers have unparalleled access to both active and passive job seekers. Our rigorous and consistent screening processes enable us to present top, qualified talent to our clients quickly, making the recruitment process as efficient as possible. Our temporary and consulting services provide employers and job seekers with flexibility. Whether it’s providing support during particularly busy times of the year, covering for an employee during a leave of absence or assisting with special projects, we can handle any of our clients’ temporary staffing needs. Additionally, our temporary-to-permanent staffing solutions provide both the job seeker and employer with the ability to evaluate whether they are the right fit for each other before making a long-term commitment.