Company: RBW Consulting
Closing Date: 12 Feb 17
Type: Full Time
Salary (£): Competitive
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.
Global Regulatory Affairs Director/Associate Director
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.
• Act as the company regulatory representative to clinical development/research project teams and to the relevant regulatory agencies
• Be responsible for regulatory direction to teams on submission strategy, communication and negotiation with regulatory agencies
• Advise and ensure that pre-clinical and clinical trial designs meet regulatory requirements
• Lead the development of submission of clinical trial applications world-wide, progress reports, amendments, and/or periodic experience reports
• Enable consistently timed arrival and completion of clinical trial applications
• Reviews and oversee prepare reports for submission
• Lead in all of the following activities: early development plan, regulatory strategy, risk management, implementation plan, and chemistry manufacturing control (CMC)
• Act as lead on extensive technical expertise and has full knowledge of other related disciplines
• Develops technical solutions to complex problems which require the regular use of ingenuity and creativity.
• Be the first point of representation for the organization as main contact on contracts and projects
• 3-7 years of regulatory experience, preferably with a strong knowledge of US regulatory affairs. Additional knowledge of other regions is highly desirable
• Additional drug development experience in discovery research, CMC, preclinical pharmacology, toxicology, clinical development or other experimentally based discipline is a must in this role
• Ability to showcase Involvement in an IND/CTA submissions and approval in a number of varieties
• Strong interpersonal, communication, negotiation and problem solving skills is an absolute must
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 email@example.com today!
Origin Two 106 High Street, Crawley
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