Senior Director, Regulatory Affairs Strategy Position Available In Mercer, New Jersey

Job Description:

Senior Director, Global Regulatory Affairs Strategy The positionwill provide regulatory affairs strategic leadership for thecompany and novel drug development programs. Of each program thisposition supports, the individual will be responsible fordeveloping and executing the overall regulatory strategy, whichincludes developing the registration pathway, interacting withregulatory agencies, and being responsible for all associatedregulatory filings. Responsibilities Develop and execute novel drugregulatory strategy Ensure development programs are compliant withICH regulatory requirements and all local country regulatoryrequirements Strong project management skills and stronginterpersonal skills to handle complex distributed programs Abilityto author clear and concise regulatory documents with oversight ofall documents for regulatory submissions and associated messagingWork closely with regulatory CMC lead and overall development teamto insure overall regulatory strategy and regulatory CMC strategyare aligned Be the point of contact between the company and theregulatory agency – serve as the regulatory liaison for the companyQualifications Master’s degree in Chemistry, Biochemistry,Pharmacy, Biomedical Engineering, or Chemical Engineering ismandatory; PhD or PharmD in above disciplines are preferred 10years industry experience a must with RA novel drug development CMCand/or Botanical experience, RAC certification Thoroughunderstanding of ICH and US CFR requirements and regulations.

Regulatory document submissions authoring experience (INDs, IMPDs,NDAs, BLAs, briefing books) Regulatory agency direct interactionexperience Strong communications skills