Regulatory Affairs Manager

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Amar Annamalai
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Regulatory Affairs Manager

Regulatory Affairs Manager
As our Manager Regulatory Affairs, you will draw on your experience of collaborating on and managing development products through EU clinical trial applications, scientific advice procedures and preparing Paediatric Investigation Plans (PIPs), and particularly your knowledge of the EU Centralised Procedure for Marketing Authorisations. For someone with your broad interests in Regulatory Affairs, it’s an opportunity to join a high calibre Global Regulatory Affairs department.
You will take a key role in the development and implementation of EU regulatory strategy for multiple and/or complex projects, designing and executing related regulatory submissions. Your brief will include planning and coordinating all aspects of regulatory submissions needed to support the lifecycle management and continued growth of a high-profile centrally authorised medicinal product in an area of high unmet medical need. Other projects are likely to include EU clinical trial applications scientific advice procedures, PIPs, orphan designation applications and virtually all other aspects of EU Regulatory Affairs, working as part of a vibrant and engaged team.
JOB REQUIREMENTS: In addition to your academic credentials, you will have experience and knowledge of a wide range of EU Regulatory Affairs projects. Your background will include liaison with Regulatory agencies, especially the EMA, preparation of Clinical Trial and Marketing Authorisation Application components, briefing packages and PIPs, and early and late global development strategies for pharmaceuticals/biologics. Experience in Regulatory Affairs for a third region (ex-US and EU) would be viewed as an asset. You should have an excellent standard of English written and verbal communication, and a second language would also be an asset.
You are also someone who is unafraid to get “hands on” when necessary, and takes as much pride in the execution as in the planning of a project. In return, you can look forward to an impressive benefits package that includes 28 days’ holiday, employee stock purchase plan and group stakeholder pension. As you would expect, we are highly health-aware, so you will also be eligible for private medical, dental and optical insurance as well as life insurance. Plus you can take advantage of our work place nursery and gym membership.
Vertex creates new possibilities in medicine. Our team discovers, develops and commercializes innovative therapies so people with serious diseases can lead better lives. Vertex scientists and our collaborators are working on new medicines to cure or significantly advance the treatment of hepatitis C, cystic fibrosis, rheumatoid arthritis and other life-threatening diseases. Founded more than 20 years ago in Cambridge, Mass., we now have ongoing worldwide research programs and sites in the United States, United Kingdom and Canada. Vertex has consistently been recognized as one of the industry’s top workplaces by leading publications such as Science magazine, The Boston Globe, Boston Business Journal, San Diego Business Journal and The Scientist. For more information and to view Vertex’s press releases, please visit
Vertex is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person’s race, color, gender, age, religion, national origin, ancestry, disability, veteran status, genetic information, sexual orientation or any characteristic protected under applicable law. Vertex will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.

Deadline: August 26, 2013

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