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).
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