What are the responsibilities and job description for the Associate Director/ Director Regulatory Affairs CMC position at Polaris Group?
Role Title : Associate Director / Director Regulatory Affairs CMC
Location : Vacaville
Department : Regulatory Affairs
Reports to : CEO
FLSA Exempt
CORE VALUES
Respect
Passion
Teamwork
Integrity
Honesty
Commitment
Collaboration
ROLE SUMMARY
In this role you will provide CMC strategy input, authoring, and oversight of CMC-related regulatory items to ensure regulatory compliance of our products. You will collaborate with cross-functional teams and regulatory authorities to help drive CMC regulatory strategies, submissions, and approvals.
ROLE RESPONSIBILITIES
Develop and execute global CMC regulatory strategies in alignment with overall product development and registration plans.
Provide strategic guidance on CMC aspects of regulatory submissions including INDs, BLAs, and ex-US submissions.
Author and review of CMC-related regulatory documents for submissions including Module 2.3, Module 3, IMPD, CMC-related briefing documents, and other CMC-associated documents.
Provide oversight and coordination for the development of CMC portions of regulatory authority submissions.
Collaborate with internal teams and external partners to ensure adherence to global regulatory guidelines and requirements. Provide CMC regulatory guidance and support to internal teams including manufacturing / MSAT, Quality Assurance, and R&D.
Lead interactions with health authorities for CMC-related matters and prepare responses to inquiries.
Proactively identify and mitigate potential CMC regulatory risks or roadblocks, developing contingency plans as needed.
Participate in regulatory authority inspections and audits, as required.
Review and approve CMC regulatory documentation, ensuring compliance with regulatory requirements.
Provide CMC regulatory support for post-approval CMC-associated commitments as well as post-marketing CMC activities.
Drive continuous improvement initiatives related to regulatory processes, standards, and practices.
SKILLS & QUALIFICATIONS
Bachelor’s degree preferably in a scientific field. An advanced degree and regulatory affairs certification are desirable.
A minimum of 6-10 years in the biotechnology industry with 4-5 years in Regulatory Affairs CMC.
Background in biologics development is highly desirable.
Knowledge and experience with authoring and preparation of global regulatory submissions (IND, CTA, BLA, MAA), post-approval and post-marketing regulatory CMC activities.
Knowledge and experience with current Good Manufacturing Practices (cGMP), CMC regulations, and International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH) guidelines.
Experience with CTD format and content.
Ability to work independently and in a group setting and to interact effectively with different functional areas.
Experience with US regulatory submissions; ex-US experience is desirable.
Detail-oriented with a focus on quality and compliance.
Strong project management skills, with the ability to prioritize tasks, manage multiple projects simultaneously, and meet deadlines.
Strong demonstrated experience with Microsoft Word, Project, and authoring templates.
Keep a pulse on the job market with advanced job matching technology.
If your compensation planning software is too rigid to deploy winning incentive strategies, it’s time to find an adaptable solution.
Compensation Planning
Enhance your organization's compensation strategy with salary data sets that HR and team managers can use to pay your staff right.
Surveys & Data Sets
What is the career path for a Associate Director/ Director Regulatory Affairs CMC?
Sign up to receive alerts about other jobs on the Associate Director/ Director Regulatory Affairs CMC career path by checking the boxes next to the positions that interest you.
View Core, Job Family, and Industry Job Skills and Competency Data for more than 15,000 Job Titles
Skills Library
Not the job you're looking for? Here are some other Associate Director/ Director Regulatory Affairs CMC jobs in the Vacaville, CA area that may be a better fit.
We don't have any other Associate Director/ Director Regulatory Affairs CMC jobs in the Vacaville, CA area right now.
