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...
Senior Manager, Business Development - Sun Pharmaceutical 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. Resumes submitted to any Sun employee by a third party agency and/or search firm without a valid written & signed search agreement, ...
AVP, Head of Integrated Delivery Network - Sun Pharmaceutical Industries, Inc.
Head of Integrated Delivery Networks (AVP), Princeton, NJ Sun 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 e...
Recruiter
Title: RecruiterSun Pharmaceutical Industries Ltd. Sunology is a combination of Sun Values and Ideology and is the way of life at Sun Pharma. Notice to Agency and Search Firm Representatives:Sun Pharmaceuticals (Sun) is not accepting unsolicited resumes from agencies and/or search firms for this job...
Associate Director, Biostatistics
The CompanySun Pharmaceutical Industries Ltd. Sun Pharma) is the fourth largest specialty generic pharmaceutical company in the world with global revenues of over US$ 5. From humble beginnings in 1983, Sun Pharma has grown to become one of the largest generic pharmaceutical companies worldwide. Sun ...
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
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, Marketing - Biologics - Sun Pharmaceutical Industries, Inc.
The Associate Director of Marketing is a team leader recognized for their ability to influence matrix team members and manage multiple agencies for the successful development and execution of both HCP and patient promotion plans. Effective cross-matrix team collaboration with Sales, Medical Affairs,...
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...