MidFull TimeEN
Job Description
Do you want to be part of our Regulatory Affairs Europe team, supporting accessibility to our new and already registered medicines?
We have a new, exciting opportunity for a Regulatory Affairs Liaison to be based in Oss (NL), Brussels (BE), or London (UK).
Purpose of the position
In this role, you will have the opportunity to coordinate regulatory activities in the EU, UK, Switzerland, and non-EU SEE countries under the supervision of the (Senior) Principal Scientist of Regulatory Affairs. You will be responsible for implementing strategies for products in development with their guidance and independently developing and executing strategies for registered products. Additionally, you will play a crucial role in managing submissions and interactions with the EU regulatory agencies. It will be your responsibility to directly liaise with HQ US-based cross-functional teams, effectively communicating regional requirements and ensuring compliance with all necessary regulations for assigned projects. You will also coordinate or oversee the preparation of regulatory documentation in a timely manner, aligning with corporate objectives. Furthermore, as an integral part of the team, you will serve as the Regulatory Affairs representative on assigned non-product related cross-functional teams.
The department
Regulatory Affairs Europe is part of Global Regulatory Affairs and Clinical Safety (GRACS). In GRACS we are always striving for operational excellence. Our group covers a wide range of activities related to getting products on the market and keeping them on the market. The health authority is our most important stakeholder; our end goal is to ensure innovative medicines reach patients. Activities are numerous and the dedication and commitment of the team is very rewarding. Our portfolio provides the chance to learn something new every day!
Primary activities
Under supervision from the (Senior) Principal Scientist, coordinate the preparation, review, and submission of regulatory dossiers for new product registrations and post-approval submissions in the EU, UK, Switzerland, and non-EU SEE countries.
Work with cross-functional project teams to develop and implement regulatory strategies, including scientific advice, pediatric investigational plans, and orphan designation.
Identify regulatory risks and ensure alignment of regulatory strategies with project teams and business objectives.
Accountable for interacting with regulatory agencies and Country RA teams to facilitate smooth submission, assessment, and quick approval of CTAs under the EU Clinical Trial Regulation.
Serve as the primary regulatory representative to regulatory agencies and Country RA teams.
Act as the Regulatory Affairs representative on assigned non-product related cross-functional teams.
Develop and implement effective processes to meet business objectives and ensure compliance with regulatory requirements.
Continuously build and maintain a sound scientific knowledge and expertise in assigned product areas and regulations.
Your profile
Master's degree in pharmacy, chemistry, or equivalent, preferably in a science-related field. Minimum of 2 years of experience in the pharmaceutical industry is preferred.
Strong organizational and planning skills, with the ability to manage multiple projects and adapt to changing priorities.
Knowledge of EU regulations, guidelines, and regulatory processes for product life cycle maintenance.
Ability to work in a cross-functional and international environment.
Fluent written and spoken English is required, along with strong interpersonal, oral, and written communication skills.
Digital & AI literacy (use of AI-enabled tools to support regulatory, administrative, and process-improvement activities).
Willingness to travel up to 5% for job-related activities.
Required Skills:
Adaptability, Chemistry, Complaint Management, Economic Impact Analysis, EU Regulations, Legal Compliance, Multi-Management, Negotiation, Pharmaceutical Regulatory Affairs, Process Improvements, Product Lifecycle, Project Tasks, Regulatory Affairs Compliance, Regulatory Affairs Management, Regulatory Communications, Regulatory Compliance, Regulatory Documents, Regulatory Experience, Regulatory Filings, Regulatory Impact Assessment, Regulatory Reporting, Regulatory Strategy Development, Stakeholder ManagementPreferred Skills:
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Search Firm Representatives Please Read Carefully
Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.
Employee Status:
RegularRelocation:
VISA Sponsorship:
Travel Requirements:
Flexible Work Arrangements:
Not ApplicableShift:
Valid Driving License:
Hazardous Material(s):
Job Posting End Date:
05/30/2026*A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.
