Senior Director, Global Regulatory Portfolio Lead
2 days ago
The Senior Director, Global Regulatory Portfolio Lead, is a key member of the Global Regulatory Affairs Leadership Team, reporting directly to the VP/Head, Global Regulatory Affairs. This role is responsible for providing leadership for the regulatory strategy of one or more in-line and pipeline assets in one or more therapeutic areas. The successful candidate will develop and implement efficient global registration pathways to secure approval and maintain licenses in multiple geographies.
Key Responsibilities
- Develop and execute regulatory strategies for assigned programs, ensuring compliance with global regulatory requirements.
- Provide strategic, tactical, and operational direction and guidance for product's pipeline and key regulatory milestones.
- Responsible for developing, executing, and maintaining the regulatory commitments and requirements for assigned programs.
- Stay abreast of regulatory agency regulations, directives, guidelines, and policies, assessing approval pathways and issues.
- Identify and communicate all issues to management related to product development that could impact product submission, approval, and product launch.
- Set and monitor submission timelines along with other key stakeholders.
- Facilitate and lead all communications with Regulatory Agencies/Health Authority as applicable.
- Ensure communication with the regulatory body is in accordance with established procedure within the department.
- Develops and manages relationships with external regulatory agencies, industry groups, and business partners.
- Reviews audit reports, Regulatory Agency inspection reports, and responses to inspection observations, as received.
- Compiles, prepares, and reviews regulatory submissions to regulatory agencies as applicable.
- Conducts department-level training, as necessary, to educate regulatory strategists and other roles in the department on regulatory requirements, policies, and procedures.
- Participates in authoring and/or reviewing of the departmental procedure as applicable.
Qualifications
- Extensive global regulatory leadership experience, demonstrated by milestones reached, health authority engagements, and staff and organizational development experience.
- Strong staff and organizational development experience, including building teams, coaching, and training both new and experienced staff.
- Broad experience in and across regulatory disciplines, including global/regional strategy, labeling, clinical, nonclinical, CMC.
- Direct experience and expertise in authoring and filing regulatory documentation across major regulated markets.
- Ability and interest in building and/or working a nimble resourcing environment.
- Advanced degree (MD, PhD, PharmD, JD, MS, MBA) preferred.
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, including 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.
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