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Job Details

Global Regulatory Affairs Manager

Company: RBW Consulting
Location:
Reference: RA-RAM-BMA
Closing Date: 12 Feb 17
Type: Full Time
Salary (£): Competitive
Benefits:

Job Summary:

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

Requirements:

Global Regulatory Affairs Manager

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.

Job Responsibilities 
• 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.
• Ensures 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.
• Ensures consistently timed arrival and completion of clinical trial applications. 
• Coordinates, reviews, and may prepare reports for submission.
• Participates in one or all of the following activities: early development plan, regulatory strategy, risk management, implementation plan, and chemistry manufacturing control (CMC). 
• Applies 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. 
• May represent organization as main contact on contracts and projects.

Job Requirements 
• 2-5 years of regulatory experience, preferably with a strong knowledge of US regulatory affairs. Additional knowledge of other regions is an asset. 
• Additional drug development experience in discovery research, CMC, preclinical pharmacology, toxicology, clinical development or other experimentally based discipline is an asset. 
• Involvement in an IND/CTA submissions and approval. 
• Regulatory operational expertise 
• 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 ross.apted@rbwconsulting.com today!

 

Apply for this job: Global Regulatory Affairs Manager

Contact Information:

Address:  US Team
Origin Two 106 High Street, Crawley
RH10 1BF
England
Tel:  (646) 586 9087
Website:  Visit Our Web Site

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