Pharming Group N.V.

Regulatory Affairs Biomedical (Senior) Specialist - Leiden

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Job

Active since 06-11-2017 Job category Quality / Health / Environment ...
Location Leiden Level Professional
Educational level Master / Post-Graduate / ... Employment type Fixed term contract with option...
Hours 32 - 40 Salary -

Introduction

Pharming Group N.V. develops innovative protein therapeutics for the treatment of genetic disorders. As the Company further develops, its legal complexity will be increasing thus requiring strengthening of its legal functions.

At this moment, the company is composed for further science, technology and new product development and commercial roll-out. The company is small (approx. 130 employees, based international) and entrepreneurial. The Regulatory Affairs Biomedical (Senior) Specialistmust fit in this organizational culture where integrity, entrepreneurship and flexibility are core competencies.

Job description

Currently we are looking for a Regulatory Affairs Biomedical (Senior) Specialist. In this role, you will be responsible for your own projects. Depending on your expertise and interests, you will be involved in the interaction with the Pharmacovigilance Department, Marketing & Sales, Market Access activities, Medical/Clinical, Regulatory labelling, or eCTD publishing activities. Depending on expertise and experience, you’ll be involved in all regulatory (non-CMC) activities.

Tasks & responsibilities:

  • Preparing, submitting and maintaining current/future MAA, BLA, and IND dossiers.
  • Ensure timely delivery of final documents for regulatory submissions in accordance with appropriate regulatory guidance
  • Coordination and preparation of responses to Health Authority questions (e.g. responses-to questions, Policy 0043 and/or 0070 requests)
  • Maintain up-to-date electronic records/archives
  • Maintain up-to-date knowledge of the relevant (EU, US and ICH) regulations and guidelines
  • Depending on expertise you will write, review and approve clinical protocols, clinical dossier texts, clinical study reports, PIP, PV documents (PSUR/DSUR), product information, educational materials, and promotional materials
  • Lead/assist in labelling or market access procedures, if applicable
  • Participate in project teams to provide regulatory input

Minimum qualifications:

Education:

  • MSc. (Bio)Pharmaceutical Sciences / Pharmacy / Biotechnology / Biology / Medical Biology / Medicine / Chemistry.
  • Skills:
  • Fluency in Dutch and English, spoken and written
  • Experience with MS Word, MS Outlook, and MS Excel
  • Knowledge of the relevant (EU, US and ICH) regulations and guidelines
  • Experience with writing and/or compiling (clinical) regulatory documents

Preferred:

At least 3-4 years’ relevant work experience in Regulatory Affairs

Knowledge of requirements for promotional material

Knowledge of pediatric investigation plans (PIPs)

Relevant work experience in a biopharmaceutical organization

Knowledge of eCTD publishing (ICH M2)

Apply:

Please apply via our website (https://pharminggroup.heeft-vacatures.nl/)

For all recruitment agencies: don’t call us, we call you!

More information
This listing is a full-time job

Job category Quality / Health / Environment / Safety
Industry / Industries Medical / Health
Region Zuid-Holland
Keywords

Contact information

Name karin Overmeer

Location

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