at AbbVie in North Chicago, Illinois, United States
Job Description
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 X (https://twitter.com/abbvieireland) , Facebook, Instagram (https://www.instagram.com/abbvieireland/) , YouTube and LinkedIn.
Job Description
Thank you for considering a future opportunity with our company! We are not currently hiring for this specific role, but we would love to connect with talented individuals who are interested in potential future positions. By joining our talent pipeline, you will be the first to be notified when suitable opportunities arise.
In this talent pipeline requisition, we are not actively recruiting for this position at the moment. However, we are building a network of exceptional individuals who possess the skills and experience required for future openings. By submitting your application to this requisition, you will be added to our talent pipeline and considered for future opportunities.
Global Regulatory Affairs Strategy roles (U.S. and Canada) are:
1. Responsible for providing regulatory strategy & support for global development.
2. 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.
3. 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.
4. Responsible for development & implementation of regulatory strategic & tactical planning (RSTP) for assigned on market products or those products in development.
5. 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.
6. Responsible for products within a Therapeutic Area & support the Global Regulatory Lead (GRL) & Therapeutic Area Head with the development & execution of the regulatory strategy.
7. Serve as HA liaison with FDA for routine communications in support of filings including complete & timely responses during application review.
8. Write regulatory documents such as meeting requests &/or briefing book activities), & lead draft review meetings.
9. 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.
10. Present pertinent regulatory information to appropriate cross-functional areas.
11. Responsible for operating in compliance with regulations, company policies, procedures, & guidance in alignment with regulatory product strategy & Quality Dossier Program (QDP).
Qualifications
+ Required Education: Bachelor’s degree (pharmacy, biology, chemistry, pharmacology) or industry related. Advanced Degree a plus. Certifications a plus.
+ A minimum of 6 years of Regulatory, R&D, or Industry-related experience is required. 2-3 years in pharmaceutical regulatory activities is preferred.
+ Demonstrates excellent negotiation skills, problem solving skills and builds consensus.
+ Demonstrates effective communication skills in written and oral channels both within Regulatory and across the organization.
+ Able to deliver challenging messages effectively without compromising important business relationships.
+ Proven skill at implementing successful US and Canada regulatory strategies regulatory strategies. Experience working in a complex and matrix environment.
+ Global regulatory experience is a plus. Experience interfacing with government regulatory agencies.
Additional Information
All your information will be kept confidential according to EEO guidelines.
AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives, serving our community and embracing diversity and inclusion. It is AbbVie’s policy to employ qualified persons of the greatest ability without discrimination against any employee or applicant for employment because of race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information, gender identity or expression, sexual orientation, marital status, status as a protected veteran, or any other legally protected group status. To learn more, visit https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html (US & Puerto Rico only)
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