Vacature Regulatory Affairs Specialist in Leiden | Modis
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Regulatory Affairs Specialist

Ref: 14541919

Toegevoegd op 21 April 2020
Vacature locatie
Leiden
Contract type
Detachering

Functieprofiel

Job summary

The Consultant RA Scientist will work with the EMEA Regulatory Liaison hand in hand with the commercial arm of the EMEA (Europe Middle East and Africa) organization to ensure rapid market access of our products and optimal support of products already on the market. The team also provides regulatory support through the entire product life cycle, by providing regional regulatory strategy, advice, HA communications and support submissions, for EMEA products and EMEA Regulatory activities through development and product life-cycle.

Input in development, post-approval and Life Cycle Management
  • Participate in global regulatory team meetings as appropriate
  • Advise the Regulatory team on applicable regulatory requirements, project specific regulatory issues as assigned
  • Develop an understanding of the regional regulatory environment, competitor intelligence and therapeutic area
Liaison with Regulatory Agencies and Local Operating Companies
  • Act as back-up for contact with Regulatory Agencies as needed
  • Assist in the preparation of meetings with Regulatory Agencies
  • Draft cover letters for Regulatory Agency communication
  • Liaise with LOCs, track and respond to queries in a timely manner
Input in document and process development
  • Assist in development of processes related to regulatory submissions
  • Draft and review some document content (depending on level of regulatory knowledge / expertise)
  • Provide input to documentation to ensure they thoroughly and accurately answer the questions being posed
  • Track dates of submissions and Regulatory Agency responses
Support of Marketing Authorization Applications (MAA) in EMEA region:
  • Provide regulatory support throughout registration process
  • Provide regulatory support throughout life-cycle management
  • Advise team on required documents and submission strategies in preparation of MAA as assigned (in collaboration with LOCs as appropriate)
  • Assist with timely MAA availability, ensure that all document components are in place on time, identify and track critical path activities
  • Assist with submission and acceptance of MAA
  • Ensure country-specific submission packages are made available to the LOCs in accordance with agreed plans
Clinical Trial Applications (CTA)
  • Review protocols and ensure alignment with regulatory requirements
  • Advise team on required documents and submission strategies in preparation of CTAs
  • Ensure CTA submission packages are complete and available according to agreed timelines

Bedrijfsprofiel

Our client is part of an international company, and develops and manufactures biologicals aiming to treat diseases in the field of cardiology, immunology and oncology.

The department

Global Regulatory Affairs; EMEA Therapeutic Area Immunology.

Functie-eisen

• University degree in Life Sciences (pharmacy, biology, veterinary etc.), or equivalent by experience;
  • Minimal 3 years of relevant Regulatory experience and Knowledge of the regulatory environment, guidelines and practice of EMEA regions
  • International team work experience is a plus
  • Fluency in English
  • Proven project management skills
  • Oral & written communication skills
  • Strong Organization & multi-tasking skills

Offer

A 32h/week contract with Modis and an exciting opportunity in a leading company in the pharmaceutical industry. You will be part of a dynamic and accomplished team

You will be working at a multidisciplinary team of Life Science professionals. You get the opportunity to develop your professional skills. Modis continues to innovate and stimulates new ways of working. In addition to getting a lot of freedom, you also get the necessary responsibilities. This way you are encouraged to continue to develop your ambitions and expertise. In this way we can grow together.

Connect Smarter.

More information

If you wish to receive more information first, please contact us on technologylifescience@modis.com or contact one of our Recruitment Consultants:

Cindy van Gorp on 06-1278 1269

Barbara Flaton on 06-2266 4285

Lars Wijnands on 06-1333 9633

I want to apply now

Please tell us who you are and what motivates you! Send us your using the application button on this website. Closing date is 21 April 2020.

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