Senior Director, Regulatory Affairs

Come Work for Us - Investing in You as a Sun Pharma EmployeeHybrid work arrangementMedical, Dental, Vision BenefitsHealth Savings Account (HSA), Flexible Spending Account (FSA)Prescription Drug CoverageTelehealth and Behavior Health ServicesIncome Protection Short Term and Long Term Disability BenefitsRetirement Benefits - 401k Company Match on Day One (100% vesting immediately)Group Life InsuranceWellness ProgramsCorporate Discounts on personal services: Cellular phones, Entertainment, and Consumer GoodsSun Pharma Vision: Reaching People And Touching Lives Globally As A Leading Provider Of Valued MedicinesSun Pharmaceutical Industries Ltd. (Sun Pharma) is the fourth largest specialty generic pharmaceutical company in the world with global revenues of over $ 4.5 billion US Dollars. Supported by more than 40 manufacturing facilities, we provide high-quality, affordable medicines, trusted by healthcare professionals and patients, to more than 100 countries across the globe including the United States. Sunology is a combination of Sun Values and Ideology and is the way of life at Sun Pharma. Sunology is Humility.Integrity.Passion.Innovation. It represents our promise to all stakeholders including patients, physicians, and employees.Our Code of ConductOur Global Code of Conduct governs every aspect of our operations. Sun Pharma is a family of thousands of people, working across many countries, speaking multiple languages, and all united, with one common purpose: to make good health accessible and affordable to local communities and society at large. Through active fieldwork, dedicated research teams, and in recognition of the efforts who work behind the scenes to combat illness and disease, the Sun Pharmaceutical Group helps as many people as possible, to secure their right to good health. The way we work every day is important to us.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 Senior 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 supports, 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 strategyInsure SPARC's development programs are compliant with ICH regulatory requirements and all local country regulatory requirementsStrong project management skills and strong interpersonal skills to handle complex distributed programsAbility to author clear and concise regulatory documents with oversight of all documents for regulatory submissions and associated messagingWork closely with regulatory CMC lead and overall development team to insure overall regulatory strategy and regulatory CMC strategy are alignedBe 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 experienceStrong communications skillsEducation Requirements:Master's degree in Chemistry, Biochemistry, Pharmacy, Biomedical Engineering, or Chemical Engineering is mandatoryPhD or PharmD in above disciplines are preferred10+ years industry experience a must with RA novel drug developmentCMC and/or Botanical experience, RAC certification