Job Title :
Regulatory Affairs Project Manager - CMC
Background :
The international ERA Consulting Group provides expert advice to the biopharmaceutical industry on process/product development and strategic regulatory affairs. ERA has a proven track record of success, and has worked on more than 400 medicinal products in its 26-year history. This places us in an unrivalled position as consultants in this demanding and highly specialised arena. Our team specialises in biological medicinal products, including monoclonal antibodies, biosimilars, and advanced therapy medicinal products. 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. For further information on ERA Consulting, please visit our website: www.eraconsulting.com.
Position :
As a regulatory affairs project manager/consultant you will be responsible for tasks and activities including: • Drafting, preparation and review of documentation for regulatory submissions • Devising regulatory strategies • Attending regulatory agency meetings • Carrying out of gap analysis and due diligence activities • Client relationship management, including oversight of project 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, we invite applications from motivated individuals with excellent scientific credentials and demonstrated project management experience. Excellent English language communication skills (written and spoken) and a strong ability to multitask are prerequisites.
You will have an advanced degree (PhD) in a relevant life science and at least 2 years’ experience in the biotech or biopharmaceutical industry, preferably with a quality (CMC) focus. One to two years’ experience in regulatory affairs and a solid understanding of ICH and GxP requirements is beneficial. Previous consultancy experience would be advantageous. Applications :
Applications in the form of a CV and cover letter, quoting the reference number ERA/UK/APP/96 should be addressed to: Dr. Chris Holloway, B.Sc., Ph.D., Dr.rer.hum.biol.habil Email: info@eraconsulting.com ERA Consulting (UK) Ltd. London Gas Museum, Twelvetrees Crescent, London E3 3JG Tel.: (020) 7510 0200 / Fax: (020) 7510 0218