Regulatory Affairs Manager

Company Description

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 strive to have a remarkable impact on people's lives across several key therapeutic areas - immunology, oncology, neuroscience, and eye care - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on Twitter, Facebook, Instagram, YouTube and LinkedIn.

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.

• Serve as HA liaison with FDA for routine communications in support of filings including complete & timely responses during application review.

• 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