Company: RBW Consulting
Closing Date: 13 Feb 17
Type: Full Time
Salary (£): Competitive
My client is a large firm based in the Cambridge, MA. With over 2 decades of experience at the highest level, this firm already has a strong product portfolio, and is looking for more individuals to take up the reins in Regulatory Affairs
Regulatory Affairs Manager
My client is a large firm based in the Cambridge, MA. With over 2 decades of experience at the highest level, this firm already has a strong product portfolio, and is looking for more individuals to take up the reins in Regulatory Affairs. As a leader of the Regulatory Affairs team, you will have the exciting opportunity to oversee and manage regulatory affairs activities focusing on antibody production, purification and conjugation.
• 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.
• 5 years of proven US regulatory experience
• 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 firstname.lastname@example.org today!
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