Regulatory Affairs Specialist - Advanced Biotherapeutics / CMC Biologics

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Boston, MA

Industry: Pharmaceuticals & Biotech

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Less than 5 years

Posted 63 days ago

  by    Sam Murphy

This job is no longer available.

My Client provides expert advice to the biopharmaceutical industry on process/product development and strategic regulatory affairs. The company has a proven track record of success, and has worked on more than 400 medicinal products in its 26-year history.

This places them in an unrivalled position as consultants in this demanding and highly specialised arena. Our team specialises in biological medicinal products, including monoclonal antibodies, biosimilars, vaccines and advanced therapy medicinal products (cell and gene therapy, etc.).

Our clients range from small biotechnology start-up companies to the largest pharmaceutical corporations. This position is based in our London office, in the neighbourhood of Canary Wharf, where the European Medicines Agency is located. We offer a stimulating working environment in an attractive office facility.

As a regulatory affairs specialist consultant you will be responsible for tasks and activities including:

• Drafting, preparation and review of documentation for regulatory submissions

• Attending regulatory agency meetings

• Carrying out of gap analysis and due diligence activities

• Client relationship management, including oversight of project plans and timelines, budgets and deliverables

• Company representation at external conferences, including the provision of training workshops

• Business development activities (e.g. identifying opportunities for work, new client meetings etc.) The company offers a competitive salary, commensurate with qualifications and experience, and this position provides an excellent training ground.

In addition, there will be opportunities for further career development and promotion within the organisation. Requirements

For this position, you will have an advanced degree (PhD) in a relevant life science and at least 2 years' experience in the biotech or bio-pharmaceutical industry, preferably with a quality (CMC) focus (applications from more experienced candidates are also welcomed). Experience in cell therapy, gene therapy, tissue-engineered products and/or regulatory affairs is beneficial. Excellent English language communication skills (written and spoken) and a strong ability to multitask are prerequisites.

Salary

$138K - $188K