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Regulatory Affairs Director
2 months ago
The Director, Global Regulatory Lead will be responsible for leading the development and execution of regulatory strategies for assigned brand programs. This role will provide strategic, tactical, and operational direction and guidance for product's pipeline and key regulatory milestones.
Key Responsibilities- Serve as key corporate regulatory contact and source of regulatory information and guidance for US market (US agent) and other markets as applicable.
- 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, etc. that could have an impact on product development to 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 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.
- At times, there may be the need for other functional areas to have a discussion with the Health Authority with their counterparts at the regulatory agency. The Regulatory Strategist/Lead should always be the point of contact and lead this interaction.
- Ensure that communication that is documented per established procedure should be distributed within the Global Regulatory Affairs team and any other external department that is directly affected by the communication.
- Must be involved in writing, or to facilitate the authoring of certain regulatory sections of product submissions.
- Develops and manages relationships with external regulatory agencies, industry groups and business partners.
- As applicable, shall review the audit reports, Regulatory Agency inspection reports and responses to the inspection observations if any, when received.
- To compile, prepare, and review regulatory submissions to regulatory agencies as applicable.
- Conduct department level training, as necessary, to educate regulatory strategists and other roles in the department on regulatory requirements, policies, and procedures.
- Participate in authoring and/or reviewing of the departmental procedure as applicable.
- 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 such as Topical Dermal, Ophthalmic and Parenteral & other dosage forms/delivery systems.
- Direct experience authoring and filing IND, CTA, NDA and BLA's across major regulated markets and a knowledge of the developing biologics regulations.
Sun Pharma offers a competitive compensation package, including a base salary, annual performance bonus, and long-term incentive plan. Employees are also 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 employee assistance program. Additionally, employees receive various paid time off benefits, including vacation time and sick time.
