Vice President Regulatory Affairs
2 weeks ago
Key Responsibilities:
- Shape and lead regulatory strategies and submissions for the company’s product portfolio to achieve corporate objectives;
- Provide regulatory guidance to project teams in all areas of regulatory affairs throughout the research and development process, approval, and post-approval phases;
- Ensure that the Company’s regulatory activities are compliant to the applicable regulatory requirements;
- Provide strategic and technical guidance and oversee the timely completion of regulatory projects and submission of documentation to regulatory agencies;
- Oversee all activities in support of INDs, NDAs, CTAs, BLAs, and other regulatory submissions like FT, BTD, ODD and PRIME;
- Provide regulatory review and final approval for all submissions and associated documentation;
- Develop and maintain current knowledge on price registration requirements and keep abreast of price registration procedures and changes, interprets regulations, give regulatory insight, advice and support to other departments;
- Serve as a primary liaison with health authorities and regulatory agencies; establish appropriate, proactive communication with agency officials to assure expedient and efficient review and approval of submissions; chair meetings between company and regulatory agencies and prepare internal teams for meetings with regulatory agencies at any phase of drug development;
- Participate in regulatory and CMC due diligence activities for licensing candidates in collaboration with business development group;
- Ability to travel as needed.
Skills, Knowledge and Expertise:
- Minimum 10+ years of relevant global regulatory leadership experience in biotech and/or pharmaceutical industry;
- Expertise in the gastroenterology, hepatology, and respiratory therapeutic areas is a key asset
- BSc or higher academic degree, including MD and Pharm D.;
- Proven track record of success in supporting successful global Phase I-III clinical trials and progressing programs including INDs, early and late-stage development plans to completion with FDA and other major regulatory agencies;
- Experience with small molecules and biologics through approval is preferred;
- Experience building teams and establishing regulatory capabilities and functions;
- Demonstrated ability to develop and maintain excellent working relationships with US FDA and similar key international regulatory agencies including the planning/ implementation of agency meetings (Experience in US is required);
- Experience with CTD format and content for regulatory filings (e.g., INDs, CTAs, NDAs/BLAs);
- Excellent interpersonal communication and presentation skills to facilitate collaboration across functions and building successful relationships with internal and external stakeholders as well as external parties;
- Experience managing complex schedules and shifting priorities in a dynamic environment;
- Ability to dissect complex issues to quickly distill key issues for discussion with regulatory authorities and guide teams in the preparation of response to regulatory questions;
- Entrepreneurial thinker and attitude, highly creative and comfortable with hands on startup culture.
-
Vice President, Regulatory Affairs
3 weeks ago
Cambridge, United States Apnimed Full timeApnimed is a well-funded, clinical-stage pharmaceutical company working to transform the treatment of sleep apnea based on a simple idea – patients with obstructive sleep apnea could benefit from treatment with a safe and effective oral medication dosed once daily at bedtime. Our lead development program targets the neurologic control of upper airway...
-
Vice President, Regulatory Affairs
2 weeks ago
cambridge, United States Apnimed Full timeApnimed is a well-funded, clinical-stage pharmaceutical company working to transform the treatment of sleep apnea based on a simple idea – patients with obstructive sleep apnea could benefit from treatment with a safe and effective oral medication dosed once daily at bedtime. Our lead development program targets the neurologic control of upper airway...
-
Vice President, Regulatory Affairs
2 weeks ago
Cambridge, United States Apnimed Full timeApnimed is a well-funded, clinical-stage pharmaceutical company working to transform the treatment of sleep apnea based on a simple idea – patients with obstructive sleep apnea could benefit from treatment with a safe and effective oral medication dosed once daily at bedtime. Our lead development program targets the neurologic control of upper airway...
-
Vice President, Regulatory Affairs
2 weeks ago
cambridge, United States Apnimed Full timeApnimed is a well-funded, clinical-stage pharmaceutical company working to transform the treatment of sleep apnea based on a simple idea – patients with obstructive sleep apnea could benefit from treatment with a safe and effective oral medication dosed once daily at bedtime. Our lead development program targets the neurologic control of upper airway...
-
cambridge, United States Apnimed Full timeApnimed is a well-funded, clinical-stage pharmaceutical company working to transform the treatment of sleep apnea based on a simple idea – patients with obstructive sleep apnea could benefit from treatment with a safe and effective oral medication dosed once daily at bedtime. Our lead development program targets the neurologic control of upper airway...
-
Cambridge, United States Apnimed Full timeApnimed is a well-funded, clinical-stage pharmaceutical company working to transform the treatment of sleep apnea based on a simple idea – patients with obstructive sleep apnea could benefit from treatment with a safe and effective oral medication dosed once daily at bedtime. Our lead development program targets the neurologic control of upper airway...
-
cambridge, United States Apnimed Full timeApnimed is a well-funded, clinical-stage pharmaceutical company working to transform the treatment of sleep apnea based on a simple idea – patients with obstructive sleep apnea could benefit from treatment with a safe and effective oral medication dosed once daily at bedtime. Our lead development program targets the neurologic control of upper airway...
-
Cambridge, United States Apnimed Full timeApnimed is a well-funded, clinical-stage pharmaceutical company working to transform the treatment of sleep apnea based on a simple idea – patients with obstructive sleep apnea could benefit from treatment with a safe and effective oral medication dosed once daily at bedtime. Our lead development program targets the neurologic control of upper airway...
-
Vice President, Regulatory Affairs
2 weeks ago
Cambridge, MA, United States Apnimed Full timeApnimed is a well-funded, clinical-stage pharmaceutical company working to transform the treatment of sleep apnea based on a simple idea – patients with obstructive sleep apnea could benefit from treatment with a safe and effective oral medication dosed once daily at bedtime. Our lead development program targets the neurologic control of upper airway...
-
Vice President Regulatory Affairs
2 weeks ago
Cambridge, United States Planet Pharma Full timeKey Responsibilities:Shape and lead regulatory strategies and submissions for the company’s product portfolio to achieve corporate objectives; Provide regulatory guidance to project teams in all areas of regulatory affairs throughout the research and development process, approval, and post-approval phases; Ensure that the Company’s regulatory activities...
-
Vice President Regulatory Affairs
2 weeks ago
cambridge, United States Planet Pharma Full timeKey Responsibilities:Shape and lead regulatory strategies and submissions for the company’s product portfolio to achieve corporate objectives; Provide regulatory guidance to project teams in all areas of regulatory affairs throughout the research and development process, approval, and post-approval phases; Ensure that the Company’s regulatory activities...
-
Vice President Regulatory Affairs
3 weeks ago
Cambridge, United States Planet Pharma Full timeKey Responsibilities:Shape and lead regulatory strategies and submissions for the company’s product portfolio to achieve corporate objectives; Provide regulatory guidance to project teams in all areas of regulatory affairs throughout the research and development process, approval, and post-approval phases; Ensure that the Company’s regulatory activities...
-
Associate Director, Regulatory Affairs CMC
3 weeks ago
Cambridge, United States Voyager Therapeutics, Inc. Full timeThe Associate Director of Regulatory Affairs CMC will be responsible for developing, implementing and advising on global Regulatory CMC strategies for new and late stage programs to secure approval of the manufacturing process and control testing for initial clinical trials under INDs/CTAs and transition to appropriate GMP validation to move expeditiously in...
-
Vice President Regulatory Affairs
2 weeks ago
Cambridge, MA, United States Planet Pharma Full timeKey Responsibilities:Shape and lead regulatory strategies and submissions for the company’s product portfolio to achieve corporate objectives; Provide regulatory guidance to project teams in all areas of regulatory affairs throughout the research and development process, approval, and post-approval phases; Ensure that the Company’s regulatory activities...
-
Vice President, Biometrics
1 month ago
cambridge, United States Proclinical Staffing Full timeVice President of Biometrics - Permanent - Cambridge, MAProclinical is seeking a proven and successful leader as a Vice President of Biometrics to have full autonomy in leading the Biometrics department for a truly exciting Rare Disease Biotech. Primary Responsibilities:The past 6 months have been the most exciting period in the company's history with...
-
Vice President, Biometrics
2 months ago
Cambridge, United States Proclinical Staffing Full timeVice President of Biometrics - Permanent - Cambridge, MAProclinical is seeking a proven and successful leader as a Vice President of Biometrics to have full autonomy in leading the Biometrics department for a truly exciting Rare Disease Biotech. Primary Responsibilities:The past 6 months have been the most exciting period in the company's history with...
-
Regulatory Affairs Director
1 month ago
Cambridge, Massachusetts, United States Lifelancer Full timeJob Title: Director/Senior Director, Regulatory AffairsAbout the Role:Lifelancer is seeking a seasoned Regulatory Affairs professional to join our team as a Director/Senior Director, Regulatory Affairs. In this critical role, you will be responsible for developing and implementing global regulatory strategies for our development programs, ensuring compliance...
-
Cambridge, Massachusetts, United States Axim Collaborative, Inc Full timeAbout the RoleAxim Collaborative, Inc. is seeking a seasoned professional to serve as the Vice President, Partnerships and External Affairs. This key leadership position will be responsible for developing high-level strategic partnerships and overseeing the organization's marketing and communications efforts.Key ResponsibilitiesCurate and manage a portfolio...
-
Regulatory Affairs Strategist
4 weeks ago
Cambridge, Massachusetts, United States Agios Pharmaceuticals Full timeAt Agios Pharmaceuticals, we're seeking a skilled Regulatory Affairs Strategist to join our growing Regulatory team.This individual will be responsible for developing and executing global regulatory strategies to support clinical development plans, working cross-functionally across the organization.The successful candidate will prepare and oversee the...
-
Regulatory Affairs Leader
4 weeks ago
Cambridge, Massachusetts, United States Relay Therapeutics Full timeThe OpportunityWe are seeking a seasoned regulatory affairs professional to join our growing team at Relay Therapeutics. As a strategic regulatory leader, you will play a critical role in defining and implementing innovative regulatory strategies to accelerate the development and approval of our transformative pipeline.You will serve as the global regulatory...
