Regulatory Affairs (Senior) Specialist General/Clinical
Reports to: Director Regulatory Affairs
Contract: 32-40 hrs.
Base location: Leiden
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 Specialist must fit in this organizational culture where integrity, entrepreneurship and flexibility are core competencies.
Overall purpose of the job
Currently we are looking for a Regulatory Affairs (Senior) Specialist General/Clinical. In this role, you will be responsible for your own clinical projects. You work closely together with the Director Regulatory Affairs, the R&D Department and the Clinical Department. Depending on your expertise and interests, you will be involved in the interaction with the Pharmacovigilance Department, Marketing, Market Access activities, Labelling, or eCTD publishing guidance 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
• 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, PV documents, product information, and educational materials
• Lead/assist in labelling or market access procedures, if applicable
• Participate in project teams to provide regulatory input
Minimum qualifications:
Education:
MSc. (Bio)Pharmaceuticals / 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
• Relevant work experience in a biopharmaceutical organization
• Knowledge of eCTD publishing (ICH M2)