Job Opportunities in Netherlands

Associate Liaison Regulatory Affairs (Senior Specialist)

Do you want to be part of our Vaccines, Infectious Diseases and General Medicine team and help bringing new medical advancements to patients?
We are an international network on the leading-edge of healthcare breakthroughs that help provide new, reliable, and compliant medical products, practices and solutions to the world. We have a new, exciting opportunity for an 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.

Depending on assigned project, it will be your responsibility to liaise and collaborate with (regional) cross-functional teams (including i CMC, EU Labeling, Manufacturing) and Country Regulatory Affairs ensuring compliance with all necessary regulations for assigned projects. You will also coordinate preparation of regulatory documentation (Module 1) in a timely manner, aligning with corporate objectives and under oversight by (Senior) Principal Scientist. Furthermore, as an integral part of the team, you may 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. We cover a wide range of activities related to getting products and keeping them on the market. The health authority is our most important stakeholder; our end goal is to ensure innovative medicines reach patients. Our large portfolio in Vaccines, Infectious Diseases and General Medicine includes medicinal products at all stages of the marketing authorization’s life cycle and span a number of therapeutic areas. 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

• 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.

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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:
Regular
Relocation:

VISA Sponsorship:

Travel Requirements:

Flexible Work Arrangements:
Not Applicable
Shift:

Valid Driving License:

Hazardous Material(s):

Job Posting End Date:
10/25/2024

• 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.
  

Job Posting End Date:10/25/2024

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.


Requisition ID:R313904