PhaRA is a Belgian based consultancy firm in Regulatory Affairs providing strategic, scientific and procedural as well as hands-on support to large pharmaceutical and smaller biotech companies.

By focusing exclusively on regulatory affairs, PhaRA can offer in-depth expertise and skills covering a broad range of RA activities throughout product development and life cycle for chemical entities and biologicals.

We are seeking to strengthen our CMC RA team with a senior CMC Regulatory Affairs Professional with more than 10 years of experience in procedural, scientific and strategic CMC regulatory affairs.

Embedded in and supported by our team, you will support our clients with more complex assignments such as developing sound CMC regulatory strategies and lead/support CMC submissions across different stages of product development (preclinical, clinical, and post-approval). You will be involved in preparation and review of the CMC sections of Regulatory Submissions including: scientific advice briefing books, IND/IMPD, MAA/NDA/BLA, and/or post approval variations ensuring accuracy, completeness, and alignment of these documents with scientific and regulatory standards. You may address potential risks in manufacturing or quality processes and provide solutions to resolve discrepancies in regulatory compliance. You may participate in client project teams in an international environment, coach more junior staff at clients or within PhaRA, and will contribute internally to define processes and best practices.

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• Master with preferably a PhD or QP background in a scientific discipline relevant to the development and manufacturing of medicinal products (eg, chemistry, biochemistry, biotechnology or pharmaceutical sciences)
• At least 10 years of experience in scientific and procedural CMC RA for medicinal product development and/or life cycle management. Seasoned in developing CMC regulatory strategies for early and late phase development programs for innovative drugs and biologicals at regional and/or global level.
• Strong scientific interest and background allowing to understand complex scientific data in several areas of drug development (quality, non-clinical, clinical) and manufacturing processes and frame these in a regulatory context. Experience in specialized areas of medicinal product development such as biologicals, ATMP, combination products, devices or IVD or other is a plus.
• Successful track record in liaising with regulatory authorities.
• Excellent analytical and organizational skills and resilience to manage multiple projects and changing priorities.
• Determination to deliver according to deadlines and high quality standards.
• Inspiring leadership towards external and internal clients.
• Experience with company stakeholder interaction at middle management is a plus.

• Excellent language skills in English, Dutch. French is a plus.
• Clear and effective communication skills.
• Good regulatory scientific writing skills.
• Strong analytical and problem solving skills.
• Good project management skills.
• Proactive and “can do” attitude.
• Customer minded and quality output driven.
• A highly motivated, dynamic person and team player who can operate in a flexible and often virtual working environment.
• Pleasant personality with effective interpersonal skills.

• A competitive salary.
  
• Varied job in a dynamic environment.
• Exchange of expertise with other experienced regulatory affairs colleagues, passionate by regulatory affairs.

If you are looking for a new challenge in regulatory affairs to contribute to medicinal product development, manufacturing and registration, building on your extensive scientific and RA experience, this position at PhaRA may be a unique opportunity for a next step in your career. While being exposed to both major pharmaceutical and biotech companies, you will work in an informal and dynamic organization. Together with PhaRA colleagues and client teams, you can live your passion in RA at an expert level, eventually fulfilling the unmet need of patient. As long as the client and PhaRA internal needs are fulfilled, flexibility in working arrangements is possible.

Belgium – the Netherlands - PortugalOur offices are easily accessible by public transport.