Strategic Regulatory Affairs Director

1 month ago


US Trenton NJ USA Sun Pharmaceutical Industries, Inc. Full time

Senior Director, Global Regulatory Affairs Strategy

The 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 regulatory agencies, and being responsible for all associated regulatory filings.

Key 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 ensure 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


  • Washington, DC , USA, United States Exelon Corporation Full time

    Job SummaryExelon Corporation is seeking a highly skilled Regulatory Affairs Director to lead the development and implementation of strategic initiatives that drive business growth and profitability. The successful candidate will have a deep understanding of regulatory policies and procedures, as well as excellent communication and leadership skills.Key...


  • US-, Trenton, NJ , USA Sun Pharmaceutical Industries, Inc. Full time

    Job Title: Senior Manager, Regulatory AffairsSun Pharmaceutical Industries, Inc. is seeking a highly skilled Senior Manager, Regulatory Affairs to join our team. As a key member of our Regulatory Affairs department, you will be responsible for handling publishing and coordinating tasks for Global RA submission activities.Key Responsibilities:Coordinate and...


  • US-, Trenton, NJ , USA Sun Pharmaceutical Industries, Inc. Full time

    Unlock Your Potential in Regulatory AffairsSun Pharmaceutical Industries, Inc. is seeking a highly skilled Senior Manager, Regulatory Affairs to join our team. As a key member of our Global Regulatory Affairs department, you will play a critical role in ensuring the timely and successful submission of regulatory documents to health authorities worldwide.Key...


  • US-, Trenton, NJ , USA Sun Pharmaceutical Industries, Inc. Full time

    Job Title: Director, Global Regulatory LeadThe Director, Global Regulatory Lead is responsible for providing strategic direction and guidance for product development and regulatory submissions. This role will serve as the key corporate regulatory contact and source of regulatory information and guidance for the US market and other markets as applicable.Key...


  • Princeton, NJ, United States Sun Pharma (Taro Pharma) Full time

    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...


  • Princeton, NJ, United States Sun Pharmaceutical Industries, Inc. Full time

    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...


  • Princeton, NJ, United States Sun Pharmaceutical Industries, Inc. Full time

    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,...


  • Ewing Township, NJ, USA, United States Panna Knows LLC Full time

    Job Title: Director of Government Policy and Regulatory AffairsPanna Knows LLC is seeking a highly skilled Director of Government Policy and Regulatory Affairs to join our team. As a key member of our organization, you will play a critical role in shaping our government relations strategy and ensuring compliance with regulatory requirements.Key...


  • United, PA , USA, United States Fairway Consulting Group Full time

    At Fairway Consulting Group, we are seeking a highly skilled Regulatory Affairs Director to join our team. This key role will be responsible for leading the development and implementation of regulatory strategies for our clients' pharmaceutical and medical device combination products.Key Responsibilities:Develop and execute regulatory strategies to ensure...


  • Princeton, NJ, United States Sun Pharmaceutical Industries, Inc. Full time

    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...


  • Princeton, NJ, United States Sun Pharma (Taro Pharma) Full time

    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...


  • Princeton, NJ, United States Sun Pharmaceutical Industries, Inc. Full time

    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...


  • Greenfield, IN , USA, United States Elanco Full time

    About the RoleAt Elanco, we are seeking a highly skilled and experienced Director of Global Regulatory Affairs to lead our pharmaceutical innovation efforts. As a key member of our team, you will be responsible for developing and implementing global regulatory strategies, collaborating with cross-functional teams, and ensuring compliance with relevant laws...


  • US-, Trenton, NJ , USA Sun Pharmaceutical Industries, Inc. Full time

    The Director of Regulatory Strategy will be responsible for leading the development and execution of regulatory strategies for assigned brand programs. This includes providing regulatory pathways for product development, reviewing clinical, non-clinical, and CMC development as needed, and acting as the US agent for communication with regulatory agencies. The...


  • Bernards, NJ, United States Daiichi Sankyo, Inc. Full time

    Join a Legacy of Innovation 110 Years and Counting!Daiichi Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and technology. With more than 100 years of scientific expertise and a...


  • Bernards, NJ, United States Daiichi Sankyo, Inc. Full time

    Join a Legacy of Innovation 125 Years and Counting! Daiichi Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and technology. With more than 125 years of scientific expertise and a...


  • US-, Trenton, NJ , USA Sun Pharmaceutical Industries, Inc. Full time

    Sun Pharmaceutical Industries, Inc. is a leading generic pharmaceutical company with a strong presence in the global market. Our mission is to develop, manufacture, and market high-quality products that meet the needs of our customers and patients. We are committed to fostering a diverse and inclusive work environment, where our employees can thrive and...


  • Bernards, NJ, United States Daiichi Sankyo, Inc. Full time

    Join a Legacy of Innovation 110 Years and Counting! Daiichi Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and technology. With more than 100 years of scientific expertise and a...


  • Bernards, NJ, United States Daiichi Sankyo, Inc. Full time

    Join a Legacy of Innovation 125 Years and Counting! Daiichi Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and technology. With more than 125 years of scientific expertise and a...


  • Bernards, NJ, United States Daiichi Sankyo, Inc. Full time

    Join a Legacy of Innovation 125 Years and Counting! Daiichi Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and technology. With more than 125 years of scientific expertise and a...