Regulatory Affairs Manager

4 days ago

South San Francisco, United States AbbVie Full time

**Company Description**
**Job Description** Key Responsibilities**
- Responsible for providing regulatory strategy & support for global development.
- Responsible for supporting teams & efforts around major filing activities & Regulatory Health Authority (RHA) interactions & meetings, attending & providing regulatory support to other departments, project teams & committees.
- Organize regulatory submissions to health authorities (HAs), including Investigational New Drug (IND)/Clinical Trial Applications (CTAs) IND/CTA amendments, Non-Disclosure Agreements (NDA)/Marketing Authorization Applications (MAA), Orphan Drug Application, Breakthrough Applications, safety reports, pre-meeting packages, & NDA post-approval submissions.
- Responsible for development & implementation of regulatory strategic & tactical planning (RSTP) for assigned on market products or those products in development.
- Assist Regulatory Staff by identifying & gathering data to support filings, responses to inquiries, & registration maintenance to enable commercialization of products that are developed, manufactured or distributed to meet relevant regulatory HA requirements.
- Responsible for products within a Therapeutic Area & support the Global Regulatory Lead (GRL) & Therapeutic Area Head with the development & execution of the regulatory strategy.
- Write regulatory documents such as meeting requests &/or briefing book activities), & lead draft review meetings.
- Advise internal cross-functional team who may contribute to regulated communication on Regulatory/FDA issues including Public Affairs, Clinical Development, Legal, & others such as Commercial. Interpret FDA/European Medicines Agency (EMA) regulations, guidelines, policy statements, etc. for drug therapeutics.
- Present pertinent regulatory information to appropriate cross-functional areas.
- Responsible for operating in compliance with regulations, company policies, procedures, & guidance in alignment with regulatory product strategy & Quality Dossier Program (QDP).

**Qualifications**
Must possess a Bachelor’s degree or foreign academic equivalent in Pharmacy, Biology, Chemistry, Pharmacology or an industry-related field of study with at least 6 years of regulatory, R&D, or industry-related experience, or a Master’s degree or foreign academic equivalent in the aforementioned fields of study with 2 years of related regulatory, R&D, or industry-related experience in:

- organizing regulatory submissions to health authorities (HAs);
- identifying & gathering data to support filings, responses to inquiries, & registration maintenance to enable commercialization of products that are developed, manufactured or distributed to meet relevant regulatory HA requirements; &
- interpreting FDA/EMA regulations, guidelines, policy statements, etc. for drug therapeutics.

Employer will accept any suitable combination of education, training, or experience.

Salary Range: $178,000 - $208,000 per year
- **Additional Information**
We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees. This job is eligible to participate in our short-term and long-term incentive programs.

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