Director Regulatory Affairs Liaison- General Medicine

05 Sep, 2022

Jobs

Director Regulatory Affairs Liaison- General Medicine

Merck
Rahway, NJ/Rockville, MD/Boston, MA/North Wales, PA

Job Description

 

New hires in office-based roles in the US & Puerto Rico will be required, subject to applicable law, to demonstrate that they have been fully vaccinated for COVID-19 or qualify for a medical or religious exemption to this vaccination requirement that can be accommodated without an undue burden to the operation. However, subject to applicable law, employees working in roles that the Company determines require routine collaboration with external stakeholders, such as employees in health services, customer facing commercial, or research based roles, will be required to be fully vaccinated as a condition of employment.

 

Our Regulatory Affairs team bring new medical advancements to the world by facilitating communications and procedures that allow swift, organized compliance across regulatory agencies. We are an international network on the leading-edge of healthcare breakthroughs that help provide new, reliable, and compliant medical products, practices and solutions to the world.

 

Looking for someone with a growth mindset. The Director, Regulatory Affairs Liaison is responsible for:

  • Developing regulatory strategy for their assigned products, in order to optimize label and obtain shortest time to approval by regulatory agencies.
  • Independently manages projects within the General Medicine Therapeutic Areafunctioning as the single, accountable, global point of contact on those projects.
  • Functions as first liaison assigned to programs where the compound is first-in-class, or is in a new therapeutic area for our company; where no regulatory guidance exists; where the program is extremely accelerated; is an Alliance program; there are multiple indications, the filing is global and/or it is a new disease target with no official regulatory guidance.
  • Independently interacts with 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.
  • 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 of all submissions and associated documentation.
  • Provides expertise as the Global Regulatory Lead 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:

  • Reports to Executive Director or Associate Vice President, Therapeutic Area Lead.
  • Develops worldwide product regulatory strategy to optimize label and obtain shortest time to approval by regulatory agencies for multiple indications simultaneously.
  • Provide leadership to the staff by leading the Global Regulatory Team which coordinates cross-functional regulatory support for development programs and marketed products.
  • Review and provide final approval of local registration study protocols when needed to obtain marketing authorization in secondary markets.
  • Represents our company with external organizations through direct communication with the FDA, including telephone calls and e-mail; chair meetings between company and FDA; prepare our company’s 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.
  • Coordinate interactions with foreign agencies through Regulatory Affairs Europe (RAE), Regulatory Affairs International (RAI), and the subsidiary registration departments to support their interactions and provide strategic direction across multiple regions simultaneously.
  • Review and provide final approval Worldwide Marketing Applications, Clinical Study Reports, protocols, Confidential Investigator Brochures before release from our company to external agencies and investigators.
  • 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.
  • Represent GRACS within our company’s internal committees to provide regulatory advice and approval according to the committee charters. (Therapeutic area document review committees (DRC), Global Regulatory Team (GRT) Product Development Team (PDT), Early Development Team (EDT), and Labeling Working Groups).
  • Participate in regulatory due diligence activities for licensing candidate review.

 

Minimum Education & Experience Requirements:

  • Degree in biological science or related discipline
  • B.S., with minimum of 7 years of relevant drug development experience
  • M.S. with minimum of 7 years relevant drug development experience
  • M.D. with minimum of 3 years relevant drug development experience or clinical experience
  • PhD/PharmD with minimum of 5 years relevant drug development experience

 

Required Experience:

  • Ability to achieve optimal results with limited day-to-day direction from Therapeutic Area Lead.

 

Preferred Experience:

  • Small and large molecule experience
  • 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” that great medicines can make a significant impact to our world. 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 …

We are known as Merck & Co., Inc., Kenilworth, New Jersey, USA in the United States and Canada and MSD everywhere else. For more than a century, we have been inventing for life, bringing forward medicines and vaccines for many of the world’s most challenging diseases. Today, our company continues to be at the forefront of research to deliver innovative health solutions and advance the prevention and treatment of diseases that threaten people and animals around the world.

 

What we look for …

Imagine getting up in the morning for a job as important as helping to save and improve lives around the world. Here, you have that opportunity. You can put your empathy, creativity, digital mastery, or scientific genius to work in collaboration with a diverse group of colleagues who pursue and bring hope to countless people who are battling some of the most challenging diseases of our time. Our team is constantly evolving, so if you are among the intellectually curious, join us—and start making your impact today.

 

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.

 

Residents of Colorado

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GRACSJOBS

New hires in office-based roles in the US & Puerto Rico will be required, subject to applicable law, to demonstrate that they have been fully vaccinated for COVID-19 or qualify for a medical or religious exemption to this vaccination requirement that can be accommodated without an undue burden to the operation. However, subject to applicable law, employees working in roles that the Company determines require routine collaboration with external stakeholders, such as employees in health services, customer facing commercial, or research based roles, will be required to be fully vaccinated as a condition of employment.

Learn more here

Job posted: 2022-09-05