Regulatory Affairs Manager

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 duringapplication 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).