Sr. Director, Regulatory Affairs Strategy
1 month ago
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.
Responsibilities
* Develop and execute novel drug regulatory strategy
* Ensure 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 the company
Qualifications
* Master's degree in Chemistry, Biochemistry, Pharmacy, Biomedical Engineering, or Chemical Engineering is mandatory; PhD or PharmD in above disciplines are preferred
* 10+ years industry experience a must with RA novel drug development
* CMC and/or Botanical experience, RAC certification
* 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
-
Sr. Director, Regulatory Affairs Strategy
4 weeks ago
Princeton, NJ, United States Sun Pharmaceutical Industries, Inc. Full timeSenior 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...
-
Sr. Director, Regulatory Affairs Strategy
5 months ago
Princeton, NJ, United States Sun Pharma (Taro Pharma) Full timeSenior 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...
-
Sr. Director, Regulatory Affairs Strategy
2 months ago
Princeton, NJ, United States Sun Pharmaceutical Industries, Inc. Full timeSenior 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...
-
Sr. Director, Regulatory Affairs Strategy
6 months ago
Princeton, NJ, United States Sun Pharma (Taro Pharma) Full timeSenior 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...
-
Sr. Director, Regulatory Affairs Strategy
4 weeks ago
Princeton, NJ, United States Sun Pharmaceutical Industries, Inc. Full timeSenior 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...
-
Sr. Director, Regulatory Affairs Strategy
5 months ago
Princeton, United States Sun Pharma (Taro Pharma) Full timeSenior 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...
-
Sr. Director, Regulatory Affairs Strategy
1 month ago
Princeton, United States Sun Pharmaceutical Industries, Inc. Full timeSenior 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...
-
Sr. Director, Regulatory Affairs Strategy
5 months ago
Princeton, United States Sun Pharma (Taro Pharma) Full timeSenior 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...
-
Sr. Director, Regulatory Affairs Strategy
5 months ago
Princeton, United States Sun Pharma (Taro Pharma) Full timeJob DescriptionSenior 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...
-
Sr. Director, Regulatory Affairs Strategy
2 months ago
Princeton, United States Sun Pharmaceutical Industries, Inc. Full timeSenior Director, Global Regulatory Affairs StrategyMake sure to read the full description below, and please apply immediately if you are confident you meet all the requirements. 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...
-
Global Director Regulatory Affairs Strategy
4 weeks ago
Princeton, New Jersey, United States Lynkx Staffing LLC Full timeJob Title: Global Director Regulatory Affairs StrategyJob Description:At Lynkx Staffing LLC, we are seeking a highly skilled Global Director Regulatory Affairs Strategy to lead our global teams in the development and execution of regulatory strategy.Key Responsibilities:* Lead Regulatory Affairs Functional Teams (RAFTs) to ensure high-quality strategic...
-
Director of Regulatory Affairs
1 week ago
Princeton, United States Success Matcher Recruitment, LLC Full timeWe are seeking a Regulatory Affairs Director to lead and drive the regulatory strategy for our growing drug portfolio. This key role will involve collaborating with cross-functional teams such as R&D, Technical Operations, Clinical Development, and others to ensure our products meet both U.S. and global regulatory standards and are positioned for commercial...
-
Director of Regulatory Affairs
3 weeks ago
Princeton, United States The Carolan Group Full timeJob Title: Director/Senior Director of Regulatory Affairs – Global Regulatory Lead (Oncology)Location: Princeton, NJ OR Mountain View, CAOverview:Our client, a leader in innovative drug development, is seeking a strategic and experienced Director or Senior Director of Regulatory Affairs to join their Global Regulatory team. This role involves developing...
-
Regulatory Affairs Strategy Lead
4 weeks ago
Princeton, New Jersey, United States Sun Pharmaceutical Industries, Inc. Full timeSenior Director, Global Regulatory Affairs StrategyThe position will provide regulatory affairs strategic leadership for Sun Pharmaceutical Industries, Inc. and novel drug development programs. The individual will be responsible for developing and executing the overall regulatory strategy, which includes developing the registration pathway, interacting with...
-
Sr. Director, Global Regulatory Affairs
2 weeks ago
Boston, MA, United States AVEO Pharmaceuticals Full timeJOB TITLE: Sr. Director, Global Regulatory Affairs REPORTS: Vice President, Regulatory Affairs DEPARTMENT: Regulatory Affairs DATE PREPARED: October 17, 2024 JOB SUMMARY: AVEO Oncology is seeking an experienced Senior Director, Regulatory Affairs who will develop and execute global regulatory strategies in support of the development for assigned...
-
Regulatory Affairs Director
1 month ago
Princeton, New Jersey, United States Lynkx Staffing LLC Full timeJob OverviewLynkx Staffing LLC is seeking a highly experienced Director Regulatory Affairs Chemistry Manufacturing & Controls (CMC) to lead global teams in developing and executing regulatory strategies for pharmaceutical clients.Develop and implement regulatory strategies for CMC components of drug development programs, collaborating with project teams and...
-
Regulatory Affairs Director
1 month ago
Princeton, New Jersey, United States TK-CHAIN LLC Full timeJob SummaryThe Director of Regulatory Affairs will play a key role in ensuring the compliance of our clients' drug development programs with US regulatory guidelines and federal regulations. This individual will be responsible for integrating and applying knowledge of regulatory guidelines and federal regulations to all aspects of our clients' drug...
-
Director, Regulatory Affairs Strategy
3 weeks ago
United, United States Fairway Consulting Group Full timeOur client is a clinical-stage biopharmaceutical company focused on developing medicines for life threating diseases. They have asked us to assist them in their search for a Director, Regulatory Affairs Strategy.Major tasks and responsibilities include: Interacts with key regulatory agency personnel to ensure the review and approval of development...
-
Director, Regulatory Affairs
2 weeks ago
Boston, MA, United States Monte Rosa Therapeutics Full timeDirector, Regulatory Affairs - Small Molecule StrategyLocation: Boston, MA USAMonte Rosa Therapeutics is seeking a highly skilled and self-motivated regulatory professional to join our team as an Associate Director of Regulatory Affairs. This role will focus on oncology, immunology, and related therapeutic areas. The successful candidate will be responsible...
-
Director of Regulatory Affairs
2 weeks ago
Weston, FL, United States Transpire Bio Full timeJob Title: Director Regulatory AffairsLocation: Weston, FL (near Miami and Fort Lauderdale, Florida (FL))Function: Regulatory AffairsReports to: Chief Regulatory Affairs Officer Job Summary:The Director of Regulatory Affairs will be responsible for the preparation and management of ANDA submission and oversee and manage all ANDA regulatory activities pre-...