Regulatory Affairs Europe, Associate Liaison

Il y a 6 mois


Brussels, Belgique MSD Temps plein

For our site in Brussels, we are looking for a Regulatory Affairs Europe, Associate Liaison

Primary Activities:

- Provides administrative regulatory support during filing and review of new submissions, variations, in order to safeguard submissions according to EU requirements.
- Plans and coordinates new submissions, variations, CHMP referrals, FUM. to ensure timely submission.
- Drafts of module 1 components and organizing the gathering of the module 1 components.
- Collaborates closely with Regulatory Operations to establish submission timelines and content of Module 1.
- Collaborates closely with Country RA Registration Managers in order to ensure timely submission.
- For the centralized procedure, supervises and coordinates the translation process to ensure timely submission to EMA.
- Provides other administrative support related to Marketing Authorization Applications to the Executive Director, Distinguished Scientist, Senior Principal Scientist, Associate Principal Scientist or Senior Scientist as needed.
- Ensures updates to regulatory databases.
- Keeps up to date with EU procedural requirements and legislation.
- Participates as SME in relevant workstreams/projects as deemed appropriate by Regulatory Affairs Europe Senior Staff.

Education/skills
- University degree (or similar such as A1 in Belgium), preferably in a science related to medicine, and at least four years of experience in the pharmaceutical industry with knowledge of the drug development and/or approval process.
- Good organizational skills, proven ability to multi-task, excellent written and verbal communication skills in English.
- Can work across boundaries, demonstrates the ability to act as intermediary across boundaries.
- Demonstrates the ability to evaluate new ideas and proposed methods for practicality and ease of implementation.
- Demonstrates ability to coordinate tasks with others for timely completion and to avoid setbacks.

**Search Firm Representatives Please Read Carefully**

**Employee Status**:
Regular

**Relocation**:
**VISA Sponsorship**:
**Travel Requirements**:
**Flexible Work Arrangements**:
**Shift**:
**Valid Driving License**:
**Hazardous Material(s)**:
**Requisition ID**:R255967



  • Brussels, Belgique MSD Temps plein

    Do you want to be part of our Oncology division, helping people fight cancer, supporting accessibility to our cancer medicines, and pursuing research in immuno-oncology to bring new hope to people with cancer? We have a new, exciting opportunity for a **Regulatory Affairs Liaison Oncology (Associate Principal Scientist) **to be based in Oss (NL), Brussels...


  • Brussels, Belgique VRS Regulatory Temps plein

    An opportunity for a Regulatory Policy Officer to join a global chemical trade association. You will be responsible for supporting all policy-related scientific and regulatory activities in Europe. This role will be diverse, challenging and offer excellent career development. You will primarily be involved in gathering, analysing and disseminating relevant...


  • Brussels, Belgique Institutional Shareholder Services Temps plein

    POSITION OVERVIEW: This is an ideal role for those interested in capital markets regulation globally and who understand the value that independent ESG research providers and proxy advisory firms provide in the market. This position will be based in our Brussels, Belgium, and the Senior Regulatory Affairs Associate will report to the Head of Regulatory...


  • Brussels, Belgique MSD Temps plein

    The Senior Regulatory Affairs Manager (RAM) has as primary task to take care of the several Regulatory Affairs (RA) activities of the RA-QA-PV Unit. For the Reg Affairs Manager this means the life cycle management of a group of product registrations of MSD AH Benelux. This life cycle management involves translation of product information texts and taking...


  • Brussels, Belgique Food Compliance International Temps plein

    **Food Compliance International is seeking to hire a Junior Food Regulatory Affairs Associate** **About the job**: - Perform the legal check of labeling, composition and advertising of innovative foods; - Assist with literature and online searches of case-law and regulatory developments; - Assist with the preparation of regulatory notes; - Drafting...


  • Brussels, Belgique Safari Club International Temps plein

    **Position: Government Affairs Liaison - Europe (Contractor)** **Hours**:Regularly requires long hours and weekend work. Some travel required. **Department**:International Government & Public Affairs **Location**: Brussels **Who We Are** Hunting is an ancient tradition passed down from the earliest times of man to the present day. Hunters participate...


  • Brussels, Belgique Boehringer Ingelheim Temps plein

    Regulatory Affairs Associate (Animal Health) | Brussels-223336 **OUR COMPANY** At Boehringer Ingelheim we develop breakthrough therapies that improve the lives of both humans and animals. Founded in 1885 and family-owned ever since, Boehringer Ingelheim takes a long-term perspective. Now, we are powered by 52,000 employees globally who nurture a diverse,...


  • Brussels, Belgique Innova Medical Group, Inc. Temps plein

    The EU Regulatory Affairs Manager maintains the official record for all European product registrations, related to the design, manufacture, and sale of medical device and in-vitro diagnostic products. Also, they will update the technical files with design changes and ensure, that additional submissions are completed. The EU Regulatory Affairs Manager will be...


  • Brussels, Belgique TMC Temps plein

    Belgium Life Sciences Brussels On-site Ready to oversee regulatory compliance for diverse products?Join us as Regulatory Affairs Officer! - About The Member Company - We are a global high-tech consultancy company with a team of entrepreneurial engineers, scientists, and digital experts from around the world. Together we form a fast-growing and proud...


  • Brussels, Belgique Hologic Temps plein

    **As a leading innovator of womens' health, we at Hologic are empowering people to live healthier lives everywhere, every day,** Our regulatory affairs team is responsible for keeping abreast of new, changing and existing regulatory requirements. They lead the development and implementation of a global vision for regulatory affairs to influence strategic...


  • Brussels, Belgique Nickel Institute Temps plein

    **Job Category**: **Project Management** **Job Experience**: **5 to 8 years** **Job Location**: **Brussels** **Expiration Date**: **06 Nov 2024** The Nickel Institute is looking for a Regulatory Affairs Manager to manage the Nickel EU REACH Consortia and provide support with other chemicals management regulations in the EU and other jurisdictions. The...


  • Brussels, Belgique MSD Temps plein

    The Regulatory Affairs Country Lead has the overall responsibility for local Regulatory Affairs in Belgium/Luxembourg and for managing related issues according to our ethics and standards. **Major activities include**: - Responsible for people management of Regulatory personnel in Belgium and provides clear leadership for the Regulatory group. Secures...

  • Senior Associate

    Il y a 3 mois


    Brussels, Belgique Regulatory Assistance Project (RAP) Temps plein

    **Job Category**: **Policy** **Job Experience**: **5 to 8 years** **Job Location**: **Brussels** **Expiration Date**: **15 Oct 2024** The Associate will provide expertise and professional experience to help guide RAP’s work in Europe and to deliver policy and technical assistance to governmental and industry decision-makers. The position requires the...


  • Brussels, Belgique MedTech Europe Temps plein

    **Key responsibilities** - Give** external affairs advice and support **in priority areas of MedTech Europe, including coordinating outreach and message alignment (e.g. regulatory affairs, international affairs, HTA ) - Build** relationships with relevant stakeholders, **such as patient and healthcare professional groups and other industry trade...


  • Brussels, Belgique Pauwels Consulting Temps plein

    In het kortbrussel / bruxelles bediende, freelancer 40 uur per week - Amandine JansenTalent Acquisition Lead Life Sciences 0032491153475 - **Regulatory Affairs Officer**: Pharma & Sciences - Regulatory Affairs - Compile and maintain regulatory documentation databases or systems - Coordinate efforts associated with the preparation of regulatory documents or...


  • Brussels, Belgique Pauwels Consulting Temps plein

    In het kortbrussel / bruxelles bediende, freelancer 40 uur per week - Amandine JansenTalent Acquisition Lead Life Sciences 0032491153475 - **Regulatory Affairs Officer**: - Pharma & Sciences - Regulatory Affairs - Compile and maintain regulatory documentation databases or systems - Coordinate efforts associated with the preparation of regulatory documents...


  • Brussels, Belgique STADA Arzneimittel AG Temps plein

    **About EG** - EG is a Purpose driven company: at the core of everything we do, we aim to Care for People´s Health as a Trusted Partner.- EG is also the largest pharmaceutical company in Belgium. With an offering for just about every therapeutic area, we are the market leader in generic medicines and the biggest OTC company in Belgian pharmacies.- Most of...


  • Brussels, Belgique Capgemini Temps plein

    At Capgemini Engineering we value excellence, care, responsibility, dynamism and innovation. We offer a job with variation that leaves plenty of room for initiative and development. In fact, we are not just offering you a job, we’re inviting you to be part of our community where we will provide you trainings, tools & grounds for professional and personal...

  • Regulatory Affairs Specialist

    il y a 4 semaines


    Brussels, Belgique SWIFT Financial Messaging Services Temps plein

    About the Role About Swift If you’ve ever sent money across borders, we’ve probably met before. We’re the ones that keep funds flowing, supply chains moving and the world’s economies turning. As the global specialist in financial transactions, we were founded to enable the financial community to move value quickly, securely and with unrivalled...


  • Brussels, Belgique Facebook App Temps plein

    Meta seeks a highly motivated, experienced lawyer to serve as Associate General Counsel, Competition and Regulatory. This position will help manage the company’s legal position and strategy on competition and regulatory related product and business strategies. The position is based at the company’s London or Brussels office. **Associate General Counsel,...