Director, Global Regulatory Affairs, Vaccines and Infectious Disease group Job - United States
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Merck & Co., Inc. Kenilworth, N.J., U.S.A. known as Merck in the United States and Canada, is a global health care leader with a diversified portfolio of prescription medicines, vaccines and animal health products. The difference between potential and achievement lies in the spark that fuels innovation and inventiveness; this is the space where Merck has codified its 125-year legacy. Merck’s success is backed by ethical integrity, forward momentum, and an inspiring mission to achieve new milestones in global healthcare.
Merck’s Regulatory Affairs organization helps bring new medical advancements to the world by facilitating the communications and procedures that allow swift, organized compliance across regulatory agencies. As a team of energetic, results-driven individuals, we’re a global network on the leading-edge of healthcare breakthroughs that help provide new, reliable, and compliant medical products, practices, and solutions to the world on time, every time.
The Director,Global Regulatory Liaison, is responsible for development and implementation of worldwide regulatory strategy for their assigned projects in the Vaccine therapeutic area. The individual functions with a high degree of independence and provides regulatory oversight for assigned products. Lead liason for programs where: the compound is first-in-class, or is in a new therapeutic area for Merck, and/or no regulatory guidance exists, works closely with regulatory colleagues outside the US , such as Regulatory Affairs Europe, Regulatory Affairs International, MSD-Japan, China and Canada to develop a global regulatory strategy and provides feedback from these regions to such teams as the Early development (EDT) and Product development (PDT) teams. Independently manages projects, functioning as the single, accountable, global point of contact on those projects as the Global regulatory liaison. 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. Coordinates the preparation, submission and follow-up contact with regulatory agencies and/or subsidiaries for all applications and submissions. Responsible for regulatory review and final approval for all submissions and associated documentation. Provides expertise as worldwide regulatory representative to Product Development Teams and regulatory single point-of-contact for products within Global Regulatory Affairs and Clinical Safety (GRACS) and external to GRACS.
Primary activities include, but are not limited to:
1. Reports to Executive Director, Therapeutic Area Lead, Pediatric Vaccines and Live VaccinesDevelops worldwide product regulatory strategy to optimize label and obtain shortest time to approval by regulatory agencies for multiple indications simultaneously.
2. Provide expert advice to Product Development Teams and subsidiaries on regulatory issues as they arise with the developmental compounds or marketed products throughout the entire life cycle of the drug.
3. Provide leadership to the staff by leading the Global Regulatory Team which coordinates cross-functional regulatory support for development programs and marketed products.
4. Review and provide final approval of local registration study protocols when needed to obtain marketing authorization in secondary markets.
5. 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 at any phase of drug development. Lead cross-functional efforts to prepare for advisory committees and may speak at the advisory committee.
6. Coordinate interactions with foreign agencies through RAE and the subsidiary registration departments to support their interactions and provide strategic direction across multiple regions simultaneously.
7. Review and provide final approval Worldwide Marketing Applications, Clinical Study Reports, protocols, Investigator Brochures before release from Merck to external agencies and investigators.
8. Represent GRA within internal Merck committees to provide regulatory advice and approval according to the committee charters (therapeutic area Document Review Committees (DRC), Product Development Team (PDT), Early Development Team (EDT), and LEAD.
9. Conducts initial IND/CSA content review and approval to facilitate initial approval by agencies for conduct of clinical trials.
10. Participate in regulatory due diligence activities for licensing candidate review
- M.D. or Ph.D. in biological science, chemistry or related discipline preferred. Other degrees such as Masters with substantial experience in regulatory affairs to suggest equivalent ability to function in this position.
- Minimum of 7 years relevant drug development or clinical experience
- Regulatory experience preferred for therapeutic area experience in Vaccines. M.D. with minimum of 3 years relevant drug development or clinical experience required; PhD with minimum of 5 years relevant drug development experience required. M.S. with minimum of 7 years relevant drug development or clinical experience, preference if this experience is in Regulatory Affairs.
- Ability to achieve optimal results with limited day-to-day direction from Therapeutic Area Lead.
- Experience is in regulatory affairs and experiences/expertise in Vaccine expertise
Your role at Merck is integral to helping the world meet new breakthroughs that affect generations to come, and we’re counting on your skills and inventiveness to help make meaningful contributions to global medical advancement. At Merck, we’re inventing for life. If you need an accommodation for the application process please email us at email@example.com.
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Job: Regulatory Affairs Liaison
Job Title:Prin. Scientist, Regulatory Liaison
Primary Location: NA-US-PA-Upper Gwynedd
Other Locations: NA-US-NJ-Rahway
Employee Status: Regular
Travel: Yes, 5 % of the Time
Number of Openings: 1
Shift (if applicable): N/A
Company Trade Name:Merck
Nearest Major Market: Philadelphia
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