MSD is a global health care leader with a diversified portfolio of prescription medicines, vaccines and animal health products. The difference between potential and achievement lies in the spark that fuels innovation and inventiveness; this is the space where MSD has codified its 125-year legacy. MSD’s success is backed by ethical integrity, forward momentum, and an inspiring mission to achieve new milestones in global healthcare.
MSD’s Regulatory Affairs division helps bring new medical advancements to the world by facilitating the communications and procedures that allow swift, organized compliance across regulatory agencies. As a team of energetic, results-driven individuals, we’re a global network on the leading-edge of healthcare breakthroughs that help provide new, reliable, and compliant medical products, practices, and solutions to the world on time, every time.
We have an exciting opportunity for a Senior Specialist Regulatory Affairs Liaison, to join our experienced and dedicated team for Regulatory Affairs Europe.
The person in this role will coordinate regulatory activities in the EEA, Switzerland and non-EU CES countries for products of our General Medicine portfolio. This includes working in teams to define and implement regulatory strategies for products in development as well as registered products. Our General Medicine portfolio comprises products in Neuroscience, Women’s’ Health, Respiratory, Dermatology, Immunology, Bone, Cardiovascular and Diabetes. The person in this role may be based in London, Brussels or Oss.
Responsible for coordinating the preparation, review and submission of regulatory dossiers in support of post-approval submissions and new product registration in the EEA, Switzerland and non-EU CES countries.
Manage interactions with the EU regulatory agencies.
Liaise directly with MSD Headquarters and US-based cross-functional teams to communicate regional requirements and ensure compliance with all the required regulations for assigned projects.
Manage European procedures, working in conjunction with regional subsidiary staff for decentralized procedures and provide assistance for national submissions in the above-mentioned region.
Work with project teams to develop and implement regulatory strategies (including scientific advices and paediatric investigational plans, or orphan designation), identify regulatory risks, and enable earliest possible approval.
Ensure regulatory strategies are aligned with project teams and business objectives and deliverables.
Ensures regulatory milestones for assigned projects are met.
Maintenance of a sound scientific knowledge and expertise for all assigned product areas.
Stay abreast on changes in the EU environment which could affect the MSD regulatory strategy.
Serve as the Regulatory Affairs representative in non-product related cross-functional teams.
Coordinate or oversee preparation of regulatory documentation in a timely manner to meet corporate objectives.
Develop and implement effective processes to meet business objectives and ensure appropriate compliance with regulatory requirements.
MSc. in Pharmacy or Chemistry or equivalent Life Science degree is required.
Minimum of 3 years of experience in regulatory affairs in the pharmaceutical industry and/or in a regulatory Health Authority.
Knowledge of EU regulations, guidelines and regulatory processes for product life cycle management.
Fluent written and spoken English.
Strong organizational and planning skills.
Ability to manage multiple projects with changing priorities and adhere to strict project timelines.
Ability to work in cross-functional and international environment.
Detail- and goal-oriented, quality conscientious, resilient and customer focused.
Good communicator and strong team player.
Problem solving skills, with ability to identify, analyze, and resolve problems in a timely manner.
Good understanding of medicinal product development and registration.
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.
Your role at MSD is integral to helping the world meet new breakthroughs that affect generations to come, and we’re counting on your skills and inventiveness to help make meaningful contributions to global medical advancement. At MSD, we’re inventing for life.
MSD is not accepting unsolicited assistance from search firms / recruitment agencies for this employment opportunity. Please, no phone calls or emails. All resumes submitted by search firms to any employee at MSD via email, the Internet or in any form and/or method without a valid written search agreement in place for this position will be deemed the sole property of MSD. No fee will be paid in the event the candidate is hired by MSD as a result of the referral or through other means.
Job: Regulatory Affairs Liaison
Job Title: EMEA-United Kingdom-ENG-London
Primary Location: EMEA-Belgium-Brussels-Capital Region-Brussels, EMEA-Netherlands-NB-Oss
Employee Status: Yes, 5 % of the Time