Senior Director, Global Regulatory Portfolio Lead

4 weeks ago

Princeton, New Jersey, United States Sun Pharmaceutical Industries, Inc. Full time
Job Summary

Sun Pharmaceutical Industries, Inc. is seeking a highly experienced Senior Director, Global Regulatory Portfolio Lead to provide strategic leadership for the company's global regulatory affairs. The successful candidate will be responsible for developing and implementing regulatory strategies to secure approval and maintain licenses in multiple geographies.

Key Responsibilities

  • Provide strategic direction and guidance for the company's global regulatory affairs, including developing and implementing regulatory strategies to secure approval and maintain licenses in multiple geographies.
  • Lead a team of regulatory professionals to ensure compliance with regulatory requirements and develop effective regulatory strategies to achieve business objectives.
  • Collaborate with cross-functional teams, including research and development, marketing, and sales, to ensure alignment on regulatory strategies and goals.
  • Develop and maintain relationships with regulatory agencies, including the FDA and EMA, to ensure timely and effective communication and to stay up-to-date on regulatory developments.
  • Stay abreast of emerging trends and issues in global regulatory affairs and provide recommendations to senior management on regulatory strategies and initiatives.
  • Develop and implement training programs to ensure regulatory awareness and compliance across the organization.
  • Manage and oversee the development of regulatory documents, including submissions and responses to regulatory agency inquiries.
  • Ensure compliance with all relevant regulatory requirements, including GxP and ISO standards.
  • Develop and maintain a comprehensive understanding of global regulatory requirements and stay up-to-date on regulatory developments.

Qualifications

  • Extensive experience in global regulatory affairs, including leadership roles in regulatory strategy and compliance.
  • Strong knowledge of global regulatory requirements, including GxP and ISO standards.
  • Excellent communication and leadership skills, with the ability to develop and maintain relationships with regulatory agencies and cross-functional teams.
  • Ability to stay up-to-date on emerging trends and issues in global regulatory affairs and provide recommendations to senior management.
  • Strong analytical and problem-solving skills, with the ability to develop and implement effective regulatory strategies.
  • Advanced degree in a relevant field, such as law, medicine, or pharmacy.

Location

  • East coast, with intermittent travel to New Jersey (Princeton), as needed or upon request.

This position is part of the Annual Performance Bonus Plan, and may be eligible for the Long Term Incentive Plan. Employees are eligible to participate in Company employee benefit programs which include medical, dental and vision coverage; life insurance; disability insurance; 401(k) savings plan; flexible spending accounts; and the employee assistance program. Employees also receive various paid time off benefits, including vacation time and sick time.

The compensation and benefits described above are subject to the terms and conditions of any governing plans, policies, practices, agreements, or other materials or documents as in effect from time to time, including but not limited to terms and conditions regarding eligibility. If hired, employee will be in an "at-will position" and the Company reserves the right to modify base salary (as well as any other discretionary payment or compensation program) at any time, including for reasons related to individual performance, Company, or individual department/team performance, and market factors.

The preceding job description has been designed to indicate the general nature and level of work performed by employees within this classification. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities and qualifications required of employees as assigned to this job. Nothing herein shall preclude the employer from changing these duties from time to time and assigning comparable duties or other duties commensurate with the experience and background of the incumbent(s).

We provide equal employment opportunities for all current employees and applicants for employment. This policy means that no one will be discriminated against because of race, religion, creed, color, national origin, nationality, citizenship, ancestry, sex, age, marital status, physical or mental disability, affectional or sexual orientation, military or veteran status, generic predisposing characteristics or any other basis prohibited by law.

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, will become the sole property of Sun. No fee will be paid if a candidate is hired for this position as a result of an unsolicited agency or search firm referral.

  • Senior Director, Global Regulatory Portfolio Lead

    4 weeks ago

    Princeton, New Jersey, United States Sun Pharmaceutical Industries, Inc. Full time

    Job Summary We are seeking a highly experienced Senior Director, Global Regulatory Portfolio Lead to join our team at Sun Pharmaceutical Industries, Inc. This is a key leadership role that will provide strategic direction and guidance for the development and implementation of global registration pathways for our products. The successful candidate will have a...

  • Senior Director, Global Regulatory Portfolio Lead

    3 weeks ago

    Princeton, New Jersey, United States Sun Pharmaceutical Industries, Inc. Full time

    The Senior Director, Global Regulatory Portfolio Lead, will provide leadership for the regulatory strategy of one or more in-line and pipeline assets in one or more therapeutic areas. This role will be a key member of the Global Regulatory Affairs Leadership Team, reporting directly to the VP/Head, GRA. The successful candidate will serve as a key corporate...

  • Senior Director, Global Regulatory Portfolio Lead

    4 weeks ago

    Princeton, New Jersey, United States Sun Pharmaceutical Industries, Inc. Full time

    Job SummaryThe Senior Director, Global Regulatory Portfolio Lead will provide leadership for the regulatory strategy of one or more in-line and pipeline assets in one or more therapeutic areas. This role will be a key member of the Global Regulatory Affairs Leadership Team, reporting directly to the VP/Head, GRA.Key Responsibilities Serve as key corporate...

  • Senior Director, Global Regulatory Portfolio Lead

    4 weeks ago

    Princeton, New Jersey, United States Sun Pharmaceutical Industries, Inc. Full time

    Job Title: Senior Director, Global Regulatory Portfolio LeadThe Senior Director, Global Regulatory Portfolio Lead, is a key member of the Global Regulatory Affairs Leadership Team, reporting directly to the VP/Head, GRA. This role is responsible for providing leadership for the regulatory strategy of one or more in-line and pipeline assets in one or more...

  • Senior Director, Regulatory Affairs Strategy Lead

    4 weeks ago

    Princeton, New Jersey, United States Sun Pharmaceutical Industries, Inc. Full time

    Senior Director, Global Regulatory Affairs Strategy **Job Summary** We are seeking a highly experienced Senior Director, Global Regulatory Affairs Strategy to provide regulatory affairs strategic leadership for our company and novel drug development programs. **Key Responsibilities:** * Develop and execute novel drug regulatory strategy * Ensure...

  • Global Director Regulatory Affairs Strategy

    4 weeks ago

    Princeton, New Jersey, United States Lynkx Staffing LLC Full time

    Job 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...

  • Senior Director Regulatory Affairs Strategy Lead

    4 weeks ago

    Princeton, New Jersey, United States Sun Pharmaceutical Industries, Inc. Full time

    Senior Director, Global Regulatory Affairs StrategyAs a key member of our team at Sun Pharmaceutical Industries, Inc., you will play a critical role in shaping the company's regulatory affairs strategy for novel drug development programs. Your expertise will be instrumental in ensuring compliance with ICH and local country regulatory requirements, as well as...

  • Senior Director, Regulatory Affairs Strategy Lead

    4 weeks ago

    Princeton, New Jersey, United States Sun Pharmaceutical Industries, Inc. Full time

    Senior Director, Regulatory Affairs Strategy LeadThe position will provide strategic leadership for the company's regulatory affairs and novel drug development programs. The individual will be responsible for developing and executing the overall regulatory strategy, including developing the registration pathway, interacting with regulatory agencies, and...

  • Senior Director, Global Drug Safety

    4 weeks ago

    Princeton Meadows, New Jersey, United States Genmab Full time

    About the RoleGenmab is seeking a highly experienced Senior Director, Global Drug Safety to join our team. As a key member of our Global Drug Safety and Pharmacovigilance team, you will be responsible for leading the development and implementation of our global safety strategy and ensuring the overall safety profile of our assigned products.Key...

  • Regulatory Affairs Director

    4 weeks ago

    Princeton, New Jersey, United States Sun Pharmaceutical Industries, Inc. Full time

    Job Title: Director, Global Regulatory LeadThe Director, Global Regulatory Lead is responsible for overseeing the development and implementation of regulatory strategies for assigned brand programs. This includes providing regulatory pathways for product development, previewing clinical, non-clinical, and CMC development as needed, acting as the US agent,...

  • Regulatory Affairs Director

    4 weeks ago

    Princeton, New Jersey, United States Lynkx Staffing LLC Full time

    Job 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 Strategy Lead

    3 weeks ago

    Princeton, New Jersey, United States Sun Pharmaceutical Industries, Inc. Full time

    Senior 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...

  • Strategic Regulatory Affairs Director

    3 weeks ago

    Princeton, New Jersey, United States Sun Pharmaceutical Industries, Inc. Full time

    Job DescriptionThe position of Senior Director, Global Regulatory Affairs Strategy, will provide 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, including developing the registration pathway, interacting with...

  • Senior Director, Regulatory Affairs Strategy

    4 weeks ago

    Princeton, New Jersey, United States Sun Pharmaceutical Industries, Inc. Full time

    Job SummaryThe Senior Director, Regulatory Affairs Strategy will provide strategic leadership for the company's regulatory affairs and novel drug development programs. This role will be responsible for developing and executing the overall regulatory strategy, including developing the registration pathway, interacting with regulatory agencies, and ensuring...

  • Regulatory Affairs Director

    4 weeks ago

    Princeton, New Jersey, United States SUN PHARMA Full time

    Job SummaryThe Director, Regulatory Strategy is responsible for leading the development and execution of regulatory strategies for assigned brand programs. This includes providing regulatory pathways for product development, interacting with regulatory agencies, and communicating with stakeholders.Key ResponsibilitiesDevelop and execute regulatory strategies...

  • Director of Procurement and Sourcing

    3 weeks ago

    Princeton, New Jersey, United States DSJ Global Full time

    Job DescriptionJob Title: Director of Procurement and SourcingJob Summary:We are seeking a highly experienced Director of Procurement and Sourcing to lead our procurement team and drive strategic sourcing initiatives. The successful candidate will have a proven track record of delivering cost savings, improving procurement processes, and building strong...

  • Senior Regulatory Counsel

    3 weeks ago

    Princeton, New Jersey, United States Bristol-Myers Squibb Company Full time

    Transforming Patients' Lives through ScienceBristol Myers Squibb is a leading pharmaceutical company that is dedicated to transforming patients' lives through science. We are seeking a highly skilled and experienced Senior Regulatory Counsel to join our team.Job SummaryThe Senior Regulatory Counsel will be responsible for providing legal support to different...

  • Savory Portfolio Director

    3 weeks ago

    Princeton Junction, New Jersey, United States dsm-firmenich Full time

    Job SummarySavory Portfolio Director is responsible for managing and optimizing a complex global portfolio of building blocks used in savory taste creations. This role requires a strategic thinker with strong analytical skills, expertise in savory ingredients, and excellent leadership and communication skills.Key Responsibilities- Manage the portfolio...

  • Head of Regulatory Interactions and Managing Director

    4 weeks ago

    Princeton, New Jersey, United States State Street Bank Full time

    Job Title:Head of Regulatory Interactions and Managing DirectorJob Summary:We are seeking a highly experienced and skilled professional to join our team as Head of Regulatory Interactions and Managing Director. This is a senior leadership position that requires a deep understanding of regulatory agencies and their supervisory processes.Key...

  • Procurement Director

    3 weeks ago

    Princeton, New Jersey, United States DSJ Global Full time

    Procurement Director Job DescriptionAt DSJ Global, we are seeking a highly skilled Procurement Director to lead our procurement team. The successful candidate will be responsible for developing and implementing procurement strategies that align with the company's goals and objectives.Key Responsibilities:Develop and implement procurement strategies that...