Executive Director, Regulatory Affairs Liaison Job at Merck, North Wales, PA

VDFuS2hjSmJTUS9ZckZRaXFpWFFQZ2JhWWc9PQ==
  • Merck
  • North Wales, PA

Job Description

Merck seeks an Executive Director to lead global regulatory strategy for ophthalmology and retinal disease programs in General Medicine. This senior role oversees a team of regulatory leads, manages complex submissions and health authority engagements, and serves as an internal regulatory expert across multiple indications.

Responsibilities

  • Develop and implement global regulatory strategy for ophthalmology programs across multiple indications
  • Oversee direct reports functioning as global points of accountability for assigned projects and regulatory authority engagement
  • Review and approve regulatory deliverables including submissions, communications, protocols, and labeling
  • Lead performance management, resource allocation, and staff development for regulatory team members
  • Represent company at external regulatory meetings, health authority engagements, and internal governance bodies

Requirements

  • B.S./M.S. in biological science with 12+ years drug development experience, majority in regulatory affairs
  • M.D./Ph.D. or PharmD. with 9+ years drug development experience and 7+ years in regulatory affairs
  • Demonstrated track record securing original NDA/BLA approvals
  • Strong scientific knowledge and familiarity with worldwide regulatory agencies
  • Leadership experience building and managing high-performing teams
  • Outstanding interpersonal, communication, and negotiation skills
  • Preferred: ophthalmology and retinal disease regulatory experience

Job Tags

Worldwide

Similar Jobs

Quality Enterprises USA, Inc.

Horizontal Directional Drill Operator Job at Quality Enterprises USA, Inc.

 ...primary responsibility is to safely and efficiently operate HDD rigs and other drilling equipment. Benefits ~ Competitive Pay...  ...management or similar field preferred. ~2+ years' experience operating an AA440 or larger drill rig required; combination of... 

SST Direct

CDL B Route Delivery Driver Job at SST Direct

DIRECT HIRE:A fantastic opportunity for an experienced CDL A Route Delivery Driver to join a dynamic team. Location : Madison, WI. Pay: $23.60/H Shift : Sunday - Thursday: 8pm to 4am Benefits : Medical, dental, vision, life insurance, 401K with company... 

Riot Games

Principal Concept Artist, Environment - League of Legends Job at Riot Games

 ...As a Concept Artist at Riot you will bring characters, creatures, environments and props to life. Drawing inspiration from as little as...  ...elegant, thoughtful ways to express fantasy. Reporting to the Concept Art Lead, youll help shape the future of Leagues art style, set... 

LPI HomeBuyers

Dispositions Manager (DM) | Remote | Real Estate | Full-Time Job at LPI HomeBuyers

 ...the right buyer and get it closed.** If you're an experienced real estate sales professional who knows how to build buyer relationships...  ...properties into successful closings. This is **not an entry-level sales position**. We're looking for someone with real estate... 

J Patrick Associates Inc

​​​​​​​AV Commissioning Engineer - ​​​​​​​Greater Los Angeles (Virtual/Remote) Job at J Patrick Associates Inc

 ...CTS-I)is preferred. Requirements : Load and Debug CodefromCrestron Toolbox Program and load DSP files that handle Audio Echo Cancellation, such as Biamp, Tesira, Clearone TestCrestron Control Panel and train end user customers on functions ...