Email Alert for
ⓘ There was an unexpected error processing your request.
Please refresh the page and try again.
If the problem persists, please contact us with your issue.
You can always manage your preferences and update your interests to ensure you receive the most relevant opportunities.
Get ready to discover your next great opportunity.
Proclinical Staffing
Boston, MA, United States
Regulatory Affairs Director - Permanent - Boston, MA Proclinical is seeking a Regulatory Affairs Director who will be responsible for the development and execution of regulatory strategies for assigned programs. This is a permanent position based in Boston, MA. Primary Responsibilities: The successful candidate will work collaboratively with variou
Job Source: Proclinical StaffingApellis Pharmaceuticals
Waltham, MA, United States
Position Summary: The Director, Regulatory Affairs will be responsible for ensuring the development and delivery of science-based, solution-oriented, and globally aligned regulatory strategies for accountable program(s). Key Responsibilities Include: Ensure alignment of global regulatory strategies with Apellis corporate objectives. Collaborate
Job Source: Apellis PharmaceuticalsDyne Tx
Waltham, MA, United States
Our commitment to people with muscle diseases Dyne Therapeutics is a clinical-stage muscle disease company focused on advancing innovative life-transforming therapeutics for people living with genetically driven diseases.With its proprietary FORCE platform, Dyne is developing modern oligonucleotide therapeutics that are designed toovercome limitati
Job Source: Dyne TxPAREXEL
Billerica, MA, United States
Great opportunity to use your regulatory expertise and lead a truly exceptional team! As a Director, Regulatory Affairs , you will use your expertise to lead and mentor a team of high-performing Regulatory Affairs professionals; provide invaluable strategic, technical, and regulatory advice to help clients with their various innovative product app
Job Source: PAREXELThe Steely Group
Cambridge, MA, United States
The Director, Regulatory Affairs will serve as a Health Authority liaison and Regulatory Project Leader for our clients multiple projects in various stages of development. This individual will establish and communicate regulatory strategies and mana Regulatory Affairs, Director, Regulatory, Leader, Product Development, Project Lead, Business Servic
Job Source: The Steely GroupPAREXEL
Billerica, MA, United States
Great opportunity to use your regulatory expertise and lead a truly exceptional team! As a Director, Regulatory Affairs , you will use your expertise to lead and mentor a team of high-performing Regulatory Affairs professionals; provide invaluable strategic, technical, and regulatory advice to help clients with their various innovative product app
Job Source: PAREXELBiofourmis
Needham Heights, MA, United States
The Director of Quality and Regulatory Affairs is responsible for developing and implementing the long range regulatory and compliance strategy by leading and directing the organizational development, processes and activities required to support the Biofourmis remote patient monitoring platforms and pharma partnerships on a global basis. Reporting
Job Source: BiofourmisRapport Therapeutics
Boston, MA, United States
As a word, Rapport describes relationships characterized by understanding, communication, teamwork, and trust. We reflect those qualities in our daily work, where we operate as one committed team that captures the collective knowledge and experience of all our members to maximally improve patients' lives. And at a higher level we share an ambition
Job Source: Rapport TherapeuticsWoburn, MA, United States
Direct the activities of US Labeling and Advertising/Promotional Review Teams. Responsible for the oversight of labeling for product registration and commercialization.Ability to provide Advertising/Promotional regulatory insight in line with applicable regulatory guidelines. Serve as a liaison and subject matter expert (SMA) on the interpretation of US Labeling and Advertising/Promotional FDA guidance documents and regulations.
Duties & Responsibilities:
Responsible for providing commercial regulatory strategy and leadership for promotional materials.
Advise internal teams and management on regulations, guidance, and industry best practices related to product labeling and advertising/promotional components.
Perform regulatory review of advertising and promotional materials, as required.
Lead cross-functional teams to facilitate discussions regarding regulatory labeling submission strategies, required documentation and regulatory risks.
Lead the MLR (medical, legal, regulatory) review committee for advertising and promotional components.
Knowledge of submission process for promotional components to FDA's Office of Prescription Drug Promotion (OPDP).
Excellent organizational, interpersonal, verbal, andwritten communication skills, strong grammar, andproofreading/editing skills, and MS Office skills are required.
Knowledge of pharmaceutical labeling, packagingcomponents, graphic arts capabilities (ADOBEIllustrator/XML), and SPL labelingprocess.
Track record of successfully working with third-partyvendors.
Create/revise SOP’s and Work Instructions as applicable, to ensure high performing regulatory operations and effective review processes.
Continuously monitor the regulatory environment for new regulations, guidance, and enforcement.
Recruit, develop and act as an advisor and coach to direct reports and junior members of the regulatory team.
Ability to rapidly adapt to changing environmentand circumstances requiring flexibility, toleranceand great sense of urgency while ensuring that allcGMP and regulatory requirements aremet.
Qualifications:
Bachelor’s degree in Life Science or other related discipline. At least 10 years’ experience in Regulatory Affairs, with direct experience in Labeling and Advertising/Promotional review. A combination of education and applicable job experience may be considered.
Experience leading team members, fostering a culture of efficiency and teamwork.
Demonstrated track record of successful product launches.
Strong expertise and knowledge of Advertising/Promotional regulations and guidance.
Excellent organizational, interpersonal, verbal, andwritten communication skills, strong grammar, andproofreading skills.
#LI-Hybrid
#J-18808-Ljbffr
Email Alert for Director, Regulatory Affairs jobs in Woburn, MA, United States
ⓘ There was an unexpected error processing your request.
Please refresh the page and try again.
If the problem persists, please contact us with your issue.
You can always manage your preferences and update your interests to ensure you receive the most relevant opportunities.
Get ready to discover your next great opportunity.