BrightOwl Loader Loading

Distinguished Scientist, Regulatory Affairs Europe Therapeutic Area Lead, General Medicine - United Kingdom  

MSD (company)


Posted on : 15 May 2017

Project Description

  • Our company  is a global health care leader with a diversified portfolio of prescription medicines, vaccines and animal health products. 
  • Today, we are building a new kind of healthcare company – one that is ready to help create a healthier future for all of us.
  • Our ability to excel depends on the integrity, knowledge, imagination, skill, diversity and teamwork of an individual like you. 
  • To this end, we strive to create an environment of mutual respect, encouragement and teamwork. 
  • As part of our global team, you’ll have the opportunity to collaborate with talented and dedicated colleagues while developing and expanding your career.

  • Act as a team leader on the General Medicine Therapeutic Area, Europe.
  •  Manage a team of regulatory liaisons / associate liaisons and provide advice and support to teams cross-functionally/cross-divisionally on the projects.
  •  Define, develop, and ensure execution of innovative regulatory strategies for development and registration of the products in scope.
  •  Ensure high quality regulatory submissions, including original marketing authorization applications, post-approval variations, scientific advice briefing documents, and PIPs.
  •  Optimize the life-cycle management of all products in the therapeutic area and ensure regulatory compliance for the assigned products in the region.
  •  Contribute to the development of the portfolio in close collaboration with key stakeholders internally in the subsidiaries and regional / global teams, as well as externally with the Regulatory Agencies for the projects assigned.
  •  Take ownership of new projects in this context; projects may be complex, broad in scope, with multiple indications or formulations, and may involve external business partners. 
  • Monitor, prioritize and supervise projects’ strategy, time lines, and milestones in compliance with applicable regulation, and ensure effective communication to / engagement from stakeholders.

  • M.D., Pharm.D. or Ph.D. in life science, complemented with 6+ years of relevant experience is required. 
  • A M.Sc. degree with substantial additional experience (6+ years) or a B.Sc. with an additional 8+ years experience in regulatory affairs or related discipline could suggest an equivalent ability to function in this position.
  • Excellent interpersonal, written and verbal communication skills both internal and with regulatory health authorities.
  • In this position strong people management skills are a pre-requisite.
  • Demonstrates the ability to translate deep knowledge and experience in the global/regional/local regulatory landscape to advise on and drive company’s cross-functional regulatory strategy.
  • Viewed as a subject matter expert related to regulatory/risk communications and submissions, and advises on effective data and presentation approaches.
  • Able to effectively influence and negotiate with regulatory agencies related to company’s submissions, clinical risk management and pharmacovigilance strategies to achieve positive regulatory outcomes.
  • Applies extensive knowledge of the disease and therapeutic environment to advise on global development strategies for a disease or therapeutic area and establishes relationships with external scientific advisers on behalf of R&D.
  • Viewed as a subject matter expert by internal and external stakeholders related to emerging trends/innovations and treatment best practices specific to a disease and therapeutic area.
  • Applies extensive knowledge of translational medicine to make strategic go/no-go decisions related to disease area studies.

  • Our employees are the key to our company’s success. 
  • We demonstrate our commitment to our employees by offering a competitive and valuable rewards program. 
  • Our Company’s benefits are designed to support the wide range of goals, needs and lifestyles of our employees, and many of the people that matter the most in their lives.

   Job Segment:  Scientific, Regulatory Affairs, Law, Scientist, Pharmacovigilance, Engineering, Legal, Science, Healthcare