The Director, Liaison, is responsible for development and implementation of worldwide regulatory strategy for their assigned early development projects in the Oncology and Immunology therapeutic area. The individual functions with a high degree of independence and provides regulatory oversight for assigned products, in order to optimize the initial development strategy to meet regulatory requirements and inform further development. Independently manages projects, functioning as the single, accountable, global point of contact on those projects. Independently interacts with the Worldwide Regulatory Agencies and/or subsidiaries with regard to global regulatory strategy/registration requirements for one or more Merck investigational and marketed drugs/Biologics. Programs may be complex with more than one indication, formulation or have an external business partner.
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- Coordinates the preparation, submission and follow-up contact with regulatory agencies and/or subsidiaries for all IND/CTA submissions.
- Responsible for regulatory review and final approval for all submissions and associated documentation.
- Provides expertise as worldwide regulatory representative to the Early Development Product Development Teams and regulatory single point-of-contact for early products within Global Regulatory Affairs and Clinical Safety (GRACS) and external to GRACS.
- Works closely with GRL’s to ensure transition of early assets into late development teams when appropriate.
Primary activities include, but are not limited to:
- Reports to Collaborations and Early development Therapeutic Area Lead
- Develops worldwide product regulatory strategy to optimize early development.
- Provide expert advice to Early Development Product Development Teams and subsidiaries on regulatory issues as they arise with the developmental compounds.
- Provide single point of contact for early development products; ensure transition of successful candidates to appropriate GRL for late development activities.
- Review and provide final approval of study protocols.
- Represents Merck with external organizations through direct communication with the FDA, including telephone calls and e-mail; chair meetings between company and FDA; prepare Merck teams for meetings with FDA.
- Review and provide final approval for Clinical Study Reports, protocols, Investigator Brochures before release from Merck to external agencies and investigators.
- Represent GRA within internal Merck committees to provide regulatory advice and approval according to the committee charters (therapeutic area Document Review Committees (DRC), Early Product Development Team (EPDT), Early Development Team (EDT).
- Conducts initial IND/CSA content review and approval to facilitate initial approval by agencies for conduct of clinical trials.
- Participate in regulatory due diligence activities for licensing candidate review.
- M.S. with minimum of 7 years relevant drug development or clinical experience, preference if this experience is in regulatory affairs.
Qualifications
Education Minimum Requirement:
- Degree in biological science, chemistry or related discipline required.
Required Experience and Skills:
- Regulatory experience preferred for therapeutic area of Oncology.
- M.D. with minimum of 5 years relevant experience required; PhD with minimum of 7 years relevant experience required.
- BSc/M.Sc. with minimum of 10 years relevant experience, notably with experience in the early development of new products.
- Ability to achieve optimal results with limited day-to-day direction from Therapeutic Area Lead.
Preferred Experience and Skills:
- Oncology, Immunology and biologics experience preferred.
- Substantial experience in regulatory affairs in one major country/region (eg. USA, EU).
- Particular expertise for regulatory considerations for FIH/Phase 1 studies to support data generation for decision making and further development for novel agents.
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