Regulatory Affairs Director

2 weeks ago

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

The Director, Global Regulatory Lead will be 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 Responsibilities

  • Develop and execute regulatory strategies for assigned programs, including providing regulatory pathway for development and preview of clinical, non-clinical, and CMC development as needed.
  • Act as US agent and communicate with regulatory agencies, interact with CROs and other stakeholders as applicable.
  • Provide strategic, tactical, and operational direction and guidance for product's pipeline and key regulatory milestones.
  • Stay abreast of regulatory agency regulations, directives, guidelines, and policies that could impact product development and assess 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 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.
  • Develop and manage relationships with external regulatory agencies, industry groups, and business partners.
  • Review audit reports, Regulatory Agency inspection reports, and responses to inspection observations as received.
  • Compile, prepare, and review regulatory submissions to regulatory agencies as applicable.
  • Conduct department-level training to educate regulatory strategists and other roles in the department on regulatory requirements, policies, and procedures.
  • Participate in authoring and/or reviewing of departmental procedures as applicable.

Requirements

  • Post-graduation in Clinical Pharmacy or similar is required.
  • PhD will be preferable.
  • Minimum of 10+ years of experience within global regulatory affairs in the pharmaceutical/biotech industry.
  • A thorough understanding of NCE drug development process and regulatory requirements for products across various routes of administration.
  • Direct experience authoring and filing IND, CTA, NDA, and BLA's across major regulated markets and a knowledge of developing biologics regulations.

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.

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