MSD Associate Liaison Regulatory Affairs 

Netherlands, North Brabant 

553551271

Job Description

Associate Liaison Regulatory Affairs (Senior Specialist)

to be based in Oss (NL), Brussels (BE), or London (UK).

Purpose of the position

In this role, you will be providing procedural, administrative, and planning support for new product registrations and post-approval submissions in the EU, UK, Switzerland, and the non-EU SEE countries under supervision from the (Senior) Principal Scientist of Regulatory Affairs. You will be supporting the (Senior) Principal Scientist to execute on strategies for products approved through the centralised and decentralised mutual recognition procedures.

Primary activities

• Provides administrative support during filling and review of new product registrations and post-approval submissions (variations, CHMP referrals, Agency commitments etc.) in the EU and the UK, Switzerland, and non-EU SEE countries;
• Plans and coordinates regulatory submissions efficiently and timely;
• Drafts some Module 1 components and organizes gathering of all Module 1 components for regulatory submissions;
• Collaborates closely and effectively with Regulatory Operations (planners, publishers) to establish submission timelines and content of Module 1;
• Collaborates effectively with Country Regulatory Affairs Registration Managers to ensure timely local submissions or local Agency communications;
• For the centralized procedure, supervises and coordinates the translation process to ensure timely submission to EMA;
• Ensures timely and accurate updates to regulatory databases;
• Coordinates new product artwork development and/or artwork updates implementation;
• Keeps up to date with EU procedural requirements and legislation;
• Contributes as Subject Matter Expert in relevant work-streams/projects per direction by Regulatory Affairs Europe Senior Staff.

Your profile

• Degree in life sciences.
• Minimum of 4 years of experience in the pharmaceutical industry or healthcare sector is preferred.
• Strong organizational and planning skills, with the ability to manage multiple tasks and to prioritize them efficiently.
• Demonstrates the ability to review regulatory documents for accuracy.
• Demonstrates ability to coordinate tasks for timely completion.
• Evaluates activities and business processes across functions, identifies areas in need for improvement and leads efforts for solution design and implementation.
• Ability to work in a cross-functional and international environment.
• Fluent written and spoken English is required, along with strong interpersonal communication skills.
• Willingness to travel up to 5% for job-related activities.

What we offer

We welcome you to a truly global, dynamic and challenging environment with great opportunities for personal development. Our benefits are very competitive, and the summary below will give you an idea of what you can expect.

• Competitive salary
• Attractive collective health care insurance package with considerable reduction rates;
• Solid Pension Plan;
• Incentive Plan;
• Numerous training, coaching and e-learning modules for long term job opportunities and development.

Current Contingent Workers apply

Not Applicable

*A job posting is effective until 11:59:59PM on the dayBEFOREthe listed job posting end date. Please ensure you apply to a job posting no later than the dayBEFOREthe job posting end date.

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.