Merck Director, Global Regulatory Liaison- Oncology in Helena, Montana
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.
The Director, Global Regulatory Lead, is responsible for development and implementation of worldwide regulatory strategy for their assigned projects in the Oncology, Immunology and Devices therapeutic area. The individual functions with a high degree of independence and provides regulatory oversight for assigned products, in order to optimize label and obtain shortest time to approval by regulatory agencies. 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. With our 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:
Reports to Executive Director, Global Regulatory Affairs Oncology
Develops worldwide product regulatory strategy to optimize label and obtain shortest time to approval by regulatory agencies for multiple indications simultaneously.
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.
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 group with external organizations through direct communication with the FDA, including telephone calls and e-mail; chair meetings between company and FDA; prepare our company 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 RAE 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, Investigator Brochures before release from our team to external agencies and investigators.
Represent GRA within internal 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.
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.
B.S. Degree in biological science, chemistry or related discipline, with minimum of 10 years drug development or clinical experience or regulatory affairs
M.S. with minimum of 10 years drug development or clinical experience or regulatory affairs
M.D. with minimum of 5 years regulatory experience
PhD with minimum of 7 years relevant regulatory experience
- Ability to achieve optimal results with limited day-to-day direction from Therapeutic Area Lead.
Immunology and biologics experience
Substantial experience in regulatory affairs in one major country/region (eg. USA, EU).
New Hires based in the US & Puerto Rico will be required to demonstrate that they have been fully vaccinated for Covid-19 or qualify for a medical or religious exemption or accommodation to this vaccination requirement, subject to applicable law.
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 …
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 .
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Flexible Work Arrangements:
Remote Work, Telecommuting
1st - Day
Valid Driving License:
Number of Openings:
Requisition ID: R149771