Sun Pharmaceuticals, Inc Director, Global Regulatory Affairs Strategist in Princeton, New Jersey
Director, Global Regulatory Affairs Strategist
Location NJ, Princeton
Job Category Regulatory Affairs
Employment Duration Full time
Sun Pharma Advanced Research Company (SPARC) is a pharmaceutical research and drug discovery organization that was formed in 2007 when SUN Pharmaceutical Industries Ltd separated out its active projects in drug discovery and innovation into a new company to provide the focus and the opportunity for growth of these projects which are now at different stages of preclinical and clinical development.
SPARC is seeking a Director, Global Regulatory Affairs Strategist to join their team at the North American corporate headquarters in Princeton, NJ.
The position is to provide regulatory affairs strategic leadership for SPARC and supported Sun novel drug development programs. Of each program this position support, the individual will be responsible for developing and executing the overall regulatory strategy, which includes developing the registration pathway, interacting with regulatory agencies, and being responsible for all associated regulatory filings.
The applicant should join SPARC to take the leadership position for clinical regulatory affairs strategy in a dynamic and rapidly growing novel drug discovery company.
Key responsibilities are to:
Develop and execute novel drug regulatory strategy
Insure SPARC’s development programs are compliant with ICH regulatory requirements and all local country regulatory requirements
Strong project management skills and strong interpersonal skills to handle complex distributed programs
Ability to author clear and concise regulatory documents with oversight of all documents for regulatory submissions and associated messaging
Work closely with regulatory CMC lead and overall development team to insure overall regulatory strategy and regulatory CMC strategy are aligned
Be the point of contact between the company and the regulatory agency – serve as the regulatory liaison for SPARC/SUN.
Technical Skills/Competencies (Software packages, experience with specific machines etc.)
Thorough understanding of ICH and US CFR requirements and regulations.
Regulatory document submissions authoring experience (INDs, IMPDs, NDAs, BLAs, briefing books)
Regulatory agency direct interaction experience
Strong communications skills
Master’s degree in Chemistry, Biochemistry, Pharmacy, Biomedical Engineering, or Chemical Engineering is mandatory
PhD or PharmD in above disciplines are preferred
7-10 years industry experience a must with RA novel drug development
CMC and/or Botanical experience, RAC certification