Senior Director, Global Regulatory Affairs Strategy The position will provide regulatory affairs strategic leadership for the company and 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.
ResponsibilitiesDevelop and execute novel drug regulatory strategyEnsure 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 the company QualificationsMaster’s degree in Chemistry, Biochemistry, Pharmacy, Biomedical Engineering, or Chemical Engineering is mandatory;
PhD or PharmD in above disciplines are preferred10+ years industry experience a must with RA novel drug developmentCMC and / or Botanical experience, RAC certificationThorough 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 skills
Sr. Director, Regulatory Affairs Strategy - Sun Pharmaceutical Industries, Inc.
Senior Director, Global Regulatory Affairs Strategy The position will provide regulatory affairs strategic leadership for the company and novel drug development programs. Of each program this position supports, the individual will be responsible for developing and executing the overall regulatory st...
Associate Director, Corporate Counsel Transactions & Legal Affairs
Sun Pharmaceuticals Industries, Inc. Sun Pharmaceuticals (Sun) is not accepting unsolicited resumes from agencies and/or search firms for this job posting. When necessary, assist the litigation team in managing litigation and investigation matters, including business disputes and regulatory. We manu...
Director, Global Regulatory Lead
The Director, Regulatory Strategy is responsible for the assigned brand programs and all strategic decisions to include providing regulatory pathway for the development, preview of clinical, non-clinical and CMC development as needed, act as US agent and communicate with the agency, interact suitabl...
Associate Director, Corporate Counsel Transactions & Legal Affairs
Sun Pharmaceuticals Industries, Inc. Sun Pharmaceuticals (Sun) is not accepting unsolicited resumes from agencies and/or search firms for this job posting. When necessary, assist the litigation team in managing litigation and investigation matters, including business disputes and regulatory. We manu...
Director, Global Regulatory Lead - Sun Pharmaceutical Industries, Inc.
The Director, Regulatory Strategy is responsible for the assigned brand programs and all strategic decisions to include providing regulatory pathway for the development, preview of clinical, non-clinical and CMC development as needed, act as US agent and communicate with the agency, interact suitabl...
Associate Vice President, Clinical Development
Provide support for internal cross-functional interactions with study teams, including research and development, regulatory affairs, medical affairs, and commercial teams Provide support for study team and Asset Lead presentations to Global Development leadership and governance to ensure that clinic...
AVP, Head of Integrated Delivery Network - Sun Pharmaceutical Industries, Inc.
Head of Integrated Delivery Networks (AVP), Princeton, NJSun is a leading specialty pharmaceutical company dedicated to improving patient outcomes through innovative and high-quality products. Collaborate with cross-functional teams, including Sales, Marketing, Medical Affairs, and Regulatory, to en...
Associate Director, Biostatistic - Sun Pharmaceutical Industries, Inc.
The CompanySun Pharmaceutical Industries Ltd. Position SummarySun Pharma is seeking an experienced and motivated Senior Principal Statistician or Associate Director of Biostatistics to join our rapidly growing organization. Sun Pharma) is the fourth largest specialty generic pharmaceutical company i...
Associate Director, Corporate Counsel Transactions & Legal Affairs - Sun Pharmaceutical Industries, Inc.
Sun Pharmaceuticals Industries, Inc. Notice to Agency and Search Firm Representatives:Sun Pharmaceuticals (Sun) is not accepting unsolicited resumes from agencies and/or search firms for this job posting. Provide legal advice to business units across the company, including advice regarding transacti...
Associate Director, Corporate Counsel Transactions & Legal Affairs
Sun Pharmaceuticals Industries, Inc. Notice to Agency and Search Firm Representatives:Sun Pharmaceuticals (Sun) is not accepting unsolicited resumes from agencies and/or search firms for this job posting. Provide legal advice to business units across the company, including advice regarding transacti...