Our Regulatory Affairs team bring new medical advancements to the world by facilitating communications and procedures that allow swift, organized compliance partnering with external regulatory agencies. We are on the leading-edge of healthcare breakthroughs that help provide new, reliable, and compliant medical products, practices and solutions to the world.
Primary activities include, but are not limited to:
- Reports to Associate Vice President, Therapeutic Area Lead, Antivirals
- Develops worldwide product regulatory strategy to optimize label and obtain shortest time to approval by regulatory agencies for multiple indications simultaneously.
- Provides 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.
- Provides leadership to the staff by leading the Global Regulatory Team which coordinates cross-functional regulatory support for development programs and marketed products.
- Represents our company with external organizations through direct communication with the FDA, including telephone calls and e-mail; chairs meetings between our company and FDA; prepares our company teams for meetings with Food and Drug Administration at all phases of drug development. Leads cross-functional efforts to prepare for advisory committees and may speak at the advisory committee.
- Coordinates interactions with foreign agencies through Regulatory Affairs Europe and the subsidiary registration departments to support their interactions and provide strategic direction across multiple regions simultaneously.
- Reviews and provides final approval Worldwide Marketing Applications, Clinical Study Reports, Protocols, Investigators' Brochures before release from our company to external agencies and investigators.
- Represents Global Regulatory Affairs within internal company committees to provide regulatory advice and approval according to the committee charters (therapeutic area Document Review Committees), Product Development Team, Early Development Team, and Label Evaluation and Development Team.
- Conducts initial Investigational New Drug application/Clinical Services Agreement content review and approval to facilitate initial approval by regulatory agencies for conduct of clinical trials.
- Participates in regulatory due diligence activities for licensing candidate review.
- Independently interacts with the Worldwide Regulatory Agencies and/or subsidiaries with regard to global regulatory strategy/registration requirements for one or more our Company's 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 and external to GRACS.
Education Minimum Requirement:
- M.D. or Ph.D. in biological science, chemistry or related discipline preferred. Other degrees such as M.S. with substantial experience in regulatory affairs to suggest equivalent ability to function in this position.
Required Experience and Skills:
- Regulatory experience preferred with therapeutic area experience in Infectious Diseases.
- 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.
Preferred Experience and Skills:
- Antivirals/Infectious Diseases experience/expertise. Substantial experience in regulatory affairs.
We are a research-driven biopharmaceutical company. Our mission is built on the simple premise that if we “follow the science” and that great medicines can make a significant impact to our world. And we believe that a research-driven enterprise dedicated to world-class science can succeed by inventing medicine and vaccine innovations that make a difference for patients across the globe.
Who we are …
Merck & Co., Inc., Kenilworth, New Jersey, USA is known as “Merck” in the United States, Canada & Puerto Rico. We are known as “MSD” in Europe, Middle East, Africa, Latin America & Asia Pacific. We are a global biopharmaceutical leader with a diverse portfolio of prescription medicines, oncology, vaccines and animal health products.
We are driven by our purpose to develop and deliver innovative products that save and improve lives. With 69,000 employees operating in more than 140 countries, we offer state of the art laboratories, plants and offices that are designed to Inspire our employees as we learn, develop and grow in our careers. We are proud of our 125 years of service to humanity and continue to be one of the world’s biggest investors in Research & Development.
What we look for …
In a world of rapid innovation, we seek brave Inventors who want to make an Impact in all aspects of our business, enabling breakthroughs that will affect generations to come. We encourage you to bring your disruptive thinking, collaborative spirit and diverse perspective to our organization. Together we will continue Inventing For Life, Impacting Lives while Inspiring Your Career Growth.
NOTICE FOR INTERNAL APPLICANTS
In accordance with Managers' Policy - Job Posting and Employee Placement, all employees subject to this policy are required to have a minimum of twelve (12) months of service in current position prior to applying for open positions.
If you have been offered a separation benefits package, but have not yet reached your separation date and are offered a position within the salary and geographical parameters as set forth in the Summary Plan Description (SPD) of your separation package, then you are no longer eligible for your separation benefits package. To discuss in more detail, please contact your HRBP or Talent Acquisition Advisor.
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We are an equal opportunity employer, Minority/Female/Disability/Veteran – proudly embracing diversity in all of its manifestations.
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Merck & Co., Inc., Kenilworth, NJ, USA, also known as Merck Sharp & Dohme Corp., Kenilworth, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.
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