Company: RBW Consulting
Location: Boston, MA
Closing Date: 11 Feb 17
Type: Full Time
Salary (£): Competitive
My client is seeking a Regulatory Affairs Associate for a full time, permanent position in Boston, MA. This role is an exciting opportunity to get involved with a highly regarded and funded firm with 1 product on the market, and another well on the way! This role would be perfect for someone relatively junior in their career within the pharmaceutical industry, or some if you are looking to make a big impact in an up and coming firm!
Regulatory Affairs Associate
Greater Boston Area
My client is an entrepreneurial mid-sized firm based in the Greater Boston area. They already have 1 highly successful drug on the market, and are making great strides in their new project already. Partnered already with 3 larger firms, there are very strong career prospects, and now is an exciting time to get on board. They consider Research/Development, Development/Commercialisation and Company Support to be the 3 equal cornerstones of the company, and this is what allows them to continue to make big waves in the industry.
· Assuming responsibility for regulatory support activities
· Helping with the Regulatory Affairs review of labelling content, product and process changes, and product documentation
· Assisting with the preparation of U.S. and/ or international regulatory submissions as and when assigned
· Oversee and assisting with communications with U.S. FDA and/ or other regulatory bodies for regulatory submissions and reviews
· Prepares and updates regulatory documents such as annual reports for approval by the Regulatory Affairs & Quality Assurance lead
· Submits work to next management level for review of quality and soundness of judgment, including, but not limited to regulatory action and submission readiness of regulatory documents
· Performs duties and projects as assigned by the Regulatory Affairs & Quality Assurance lead
· BA/BS Degree in life sciences or engineering, or an acceptable alternative, is required
· 2 to 4 years’ experience in the pharmaceutical industry
· Good knowledge or exposure to the relevant US/international regulatory requirements for drug development
· Up to date and extensive knowledge of current FDA/Regulatory Affairs submission requirements
· Showcase proven ability to plan, prioritize, balance, schedule, and manage multiple activities and deadline
· Any relevant qualifications additional to the degree is highly desirable, such as Regulatory Affairs Certification (RAC)
I manage a range of other permanent and freelance positions for a broad portfolio of clients, so if the above role isn’t for you but you’d nevertheless like to discuss other opportunities currently available both now and in the near future, we are happy to get in touch at your discretion. Contact Ross Apted at (646) 586 9087, or by email on firstname.lastname@example.org today!
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