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
Senior Manager, Regulatory Affairs
Sun Pharmaceutical Industries Ltd. Sunology is a combination of Sun Values and Ideology and is the way of life at Sun Pharma. Sun Pharma) is the fourth largest specialty generic pharmaceutical company in the world with global revenues of over $ 4. Through active fieldwork, dedicated research teams, ...
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...
Senior Statistical Programmer
Sun Pharmaceutical Industries Inc. Sunology is a combination of Sun Values and Ideology and is the way of life at Sun Pharma. Sun Pharma) is the fourth largest specialty generic pharmaceutical company in the world with global revenues of over $ 5 billion US Dollars. Description: Sun is seeking a Sen...
Senior Statistical Programmer - Sun Pharmaceutical Industries, Inc.
Sun Pharmaceutical Industries Inc. Sunology is a combination of Sun Values and Ideology and is the way of life at Sun Pharma. Sun Pharma) is the fourth largest specialty generic pharmaceutical company in the world with global revenues of over $ 5 billion US Dollars. Description: Sun is seeking a Sen...
Senior Director, Commercial Operations - Sun Pharmaceutical Industries, Inc.
Princeton, New Jersey (HYBRID: 3 days in office; 2 days remote) Summary:A key member of the Commercial Leadership Team, the Senior Director, Commercial Operations leads and manages commercial functions to include sales operations, sales insights and analytics, sales reporting, market insights and an...
Regional Business Director - Sun Pharmaceutical Industries, Inc.
These critical business partners include: Strategic Market Directors, National Account Directors, Territory Managers, Region Sales Managers, Corporate Account Directors, and National Sales Directors. Regional Business Director of Field Reimbursement The Region Business Director of Field Reimbursemen...
Regional Business Director
These critical business partners include: Strategic Market Directors, National Account Directors, Territory Managers, Region Sales Managers, Corporate Account Directors, and National Sales Directors. Regional Business Director of Field Reimbursement The Region Business Director of Field Reimbursemen...
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...
Senior Director, Global Regulatory Portfolio Lead
The Senior Director (Global Regulatory Portfolio Leader), Global Regulatory Affairs (GRA), Specialty Business (Brands and Innovative Medicines), is empowered to provide leadership for the regulatory strategy of one or more in-line and pipeline assets in one or more therapeutic areas and (potentially...
Senior Manager, Regulatory Affairs - Sun Pharmaceutical Industries, Inc.
COME WORK FOR US - INVESTING IN YOU AS A SUN PHARMA EMPLOYEE!Hybrid 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 B...