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Senior Associate, Regulatory Affairs - Chemistry, Manufacturing & Control (CMC)
AbbVie • North Chicago, IL13h • Hybrid
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Senior Associate, Regulatory Affairs - Chemistry, Manufacturing & Control (CMC) - Hybrid
AbbVie•North Chicago, IL
•Hybrid
About The Position
The Senior Associate, RA CMC is responsible for ensuring RA-CMC post approval change objectives are met by project managing marketed product variations including authoring and compilation of chemistry, manufacturing, and control (CMC) sections to ensure timely preparation of submission documents. The Senior Associate will also ensure proper communication with all key partners in the functional departments in support of regulatory filings.
Requirements
- Minimum of a BA/BS Degree in Chemical, and/or, Biological Sciences/relevant discipline
- 4 years pharmaceutical or industry related experience.
- 1-2 years in quality systems or cross functional project management
Nice To Haves
- 5 years pharmaceutical experience including 1-2 years in regulatory affairs or 1-2 years in Discovery, R&D, or Manufacturing
- Strong working knowledge of manufacturing unit operations or CTD structure
- Superior oral and written communication skills
- Ability to work cooperatively with all levels and types of global personnel required
- Experience working with electronic document management systems
- Ability to work independently under pressure and manage multiple projects simultaneously
- Detail/accuracy oriented
- Collaborative and willing to learn
- Familiarity with US and other international regulatory requirements for drug product dossiers
Responsibilities
- Manage, compile, and author CMC sections of marketed product variations with minimal management oversight.
- Update simple CMC documents independently.
- Partner with RA CMC Project Leads to create and develop content plans, bundling strategies, and project timelines.
- Collaborate with diverse functional groups to ensure file-ability and acceptance of CMC sections.
- Manage assigned projects to ensure thoroughness, accuracy, and timeliness of CMC dossiers and responses.
- Independently run team review and management reviews of submission documents.
- Ensure CMC expectations including CTD content, structural and formatting requirements are being met for assigned projects.
- Provide input into and utilize current best practices for use of regulatory business systems within the group.
- Timely communication of systems issues to management.
- Communicate content gaps and risks for variation documents identified by RA CMC Project Leads.
- Provide guidance on use of submission document templates.
- Support annual reports and renewals (ad hoc baseline support)
Benefits
- paid time off (vacation, holidays, sick)
- medical/dental/vision insurance
- 401(k)
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What This Job Offers
Job Type
Full-time
Career Level
Senior
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Common questions about Regulatory Affairs Associate careers and jobs.
Based on current job postings on Teal, the average Regulatory Affairs Associate salary in the US is approximately $74,000 per year, with a typical range of $52,000 to $119,000.
