AbbVie
Manager, Regulatory Affairs for Chemistry Manufacturing & Controls (CMC)
North Chicago, IL, United States
Sponsorship not specifiedDetected 1 day ago
Content MarketingCustomer SupportPharmacologyFDA RegulatoryResearchCommunicationRegulatory Affairs
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About the role
- For more information about AbbVie, please visit us at www.abbvie.com.
- Follow @abbvie on LinkedIn, Facebook, Instagram, X and YouTube.
- Prepares CMC regulatory strategies that enable first pass approvals under limited management supervision.
Responsibilities
- Develop strategies for CMC-related agency interactions and manage preparation of agency meeting requests and information packages, under limited supervision
- Manage products and change control with an understanding of regulations, agency guidance and company policies and procedures with limited supervision. Analyzes and approves manufacturing change records with limited supervision.
- Represents CMC regulatory affairs on teams such as the product development, Global Regulatory Product Teams and Operations Product Teams, for assigned projects; negotiates with and influences team members with support of management to maximize chances for first pass approval of regulatory submissions and stays abreast of regulatory procedures and changes in the external regulatory environment.
- The Manager, Regulatory Affairs for Chemistry Manufacturing & Controls (CMC) - Biologics Product Lead, works with internal and external partners in order to deliver products to patients.
- Develops and manages content strategy for regulatory submissions, including INDs/CTAs and amendments, new market applications and supplements/variations with limited management supervision.
- Builds and maintain relationships within the Regulatory Affairs functional areas and the Operations and Research & Development (R&D) organizations.
Requirements
- 6 years' biopharmaceutical or related industry experience.
- Seeks expert advice and technical support as required for strategies and submissions
- Significant Work Activities: Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hr day) is required
- Required Experience: 6 years' biopharmaceutical or related industry experience.
Nice to have
- Relevant advanced degree preferred.
- Certification a plus.
- Preferred Experience: 6 years biopharmaceutical RA, R&D or Operations experience including 3 years in regulatory affairs
Compensation
- Prepares CMC regulatory product strategies with limited supervision. Prepares regulatory submissions, including new IND/CTA applications and amendments, renewals, annual reports, supplements and variations under limited supervision.
Benefits
- AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow.
- We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees.
- Required Education: Bachelor's degree in pharmacy, biology, chemistry, pharmacology, engineering or related subject.
- Preferred Education: Relevant advanced degree preferred.
Company info
- We strive to have a remarkable impact on people's lives across several key therapeutic areas including immunology, oncology and neuroscience - and products and services in our Allergan Aesthetics portfolio.
Equal opportunity
- Employer/Veterans/Disabled.
- US & Puerto Rico only - to learn more, visit https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html
- US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:
- https://www.abbvie.com/join-us/reasonable-accommodations.html
This listing is sourced directly from AbbVie's careers page and normalized into a canonical job model.