Senior Regulatory Affairs manager - CMC
- Author and compile CMC sections of regulatory applications, including INDs, IMPDs, CTAs, amendments, and annual reports.
- Documentation: Draft and maintain high-quality CMC regulatory documents such as Module 2 and 3 summaries, stability reports, and comparability protocols.
- Communication: Support regulatory interactions by preparing responses to CMC-related questions from FDA, EMA, PMDA, and other global health authorities.
- Strategy Implementation: Execute CMC regulatory strategies as defined by regulatory leadership to support clinical trial initiation and advancement.
- Cross-functional Collaboration: Partner with Technical Operations, Quality, Manufacturing, and external vendors to gather, verify, and compile CMC information.
- Process Development: Contribute to the development of templates, processes, and workflows to support efficient and compliant CMC regulatory operations.
- Other duties as assigned.
- Bachelor's degree with a minimum of 5+ years of experience in CMC regulatory affairs, including experience with clinical biologics programs or equivalent related experience.
- Hands-on experience authoring and compiling CMC sections of INDs, IMPDs, CTAs, amendments, and related filings.
- Strong knowledge of global CMC clinical regulatory requirements and guidelines, including FDA, EMA, and ICH.
- Experience with biologics, drug-device combination products (e.g., pre-filled syringes, auto-injectors), or diagnostics (companion diagnostics) preferred.
- Excellent attention to detail, technical writing, organizational, and communication skills.
- Ability to manage multiple deliverables and timelines in a fast-paced environment.
- Proficiency with regulatory document management systems.
Recommended Jobs
Financial Professional Internship
Job Description Job Description An internship at The Moody Street Group gives you valuable, real-world work experience to prepare you for a career in Financial Services or other fields, while b…
Associate - Manufacturing
Your Impact As an Associate, you will join a client service team and take ownership of a workstream to solve some of the toughest challenges our clients face. Your clients won't be just any clients—…
Manager - Rest Home - Group Home
Job Description Job Description Benefits: ~401(k) ~401(k) matching ~ Bonus based on performance ~ Dental insurance ~ Health insurance ~ Paid time off ~ Vision insurance Positi…
Locum Anesthesiologist
Locum Anesthesiologist Opportunity Central Massachusetts Premier Academic & Community Settings | Premium 1099 Rates | Flexible Terms | No Call A highly respected academic health system in centr…
Registered Nurse - Full Time
Job Description Job Description Description: We are currently seeking a compassionate and skilled Registered Nurse (RN) to join our community-based primary care team. In this role, you’ll work …
Clinical Research Accounting Specialist
Overview Under direct supervision of the Senior Clinical Research Accounts Specialist, the Clinical Research Accounting Specialist I is responsible for financial reconciliation and invoicing and…
Cloud DevOps Engineer
Apply now: Cloud DevOps Engineer , location is Remote . The start date is ASAP for this Contract position. Job Title: Cloud DevOps Engineer Location-Type: Remote Start Date Is: ASAP …
Automotive Collision Repair Technician
Jaffarian Automotive Group is searching for experienced automotive body technicians to join our team and help to deliver the growing demands. We offer high volume, high energy team dedicated to delive…
Operations Manager
The Operations Manager at Cartier in Boston is responsible for overseeing boutique operations, ensuring compliance with Maison policies, and achieving operational excellence. This role involves managi…
Lead Deck Hand & Vessel Operator
Job Description Job Description Lead Deckhand / Vessel Operator (USCG Master I & II) Falmouth, MA (WHOI); Pocasset, MA; and Narragansett, RI This role involves significant time on board rese…