Director, Global Regulatory Lead

The Director, Regulatory Strategy is responsible for the assigned brand programs and all strategic decisions to include providing regulatory pathway for the development, preview of clinical, non-clinical and CMC development as needed, act as US agent and communicate with the agency, interact suitably with CROs and all other stakeholders as applicable.

The position is located in Princeton. The workweek is Hybrid. 3 days in office; 2 days remote.

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

Qualifications

• 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
• 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; (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.

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