Pharmiweb ChannelsAll | PharmaCo | Clinical Research | R&D/BioTech | Sales/Mktg | Healthcare | Recruitment | Pharmacy | Medical Comms

Pharmiweb.com RSS Feed Pharmiweb.com RSS Feeds

Pharmiweb.com RSS Feed PharmiWeb Candidate Blog

Pharmiweb.com RSS Feed PharmiWeb Client Blog

Job Details

Regulatory Affairs Manager

Company: RBW Consulting
Location:
Reference: RA-RAM-CMA
Closing Date: 13 Feb 17
Type: Full Time
Salary (£): Competitive
Benefits:

Job Summary:

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

Requirements:

Regulatory Affairs Manager

Cambridge, MA

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.

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 
• 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 ross.apted@rbwconsulting.com today!
 

Apply for this job: 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

Advertising
Share | | |
Site Map | Privacy & Security | Cookies | Terms and Conditions

PharmiWeb.com is Europe's leading industry-sponsored portal for the Pharmaceutical sector, providing the latest jobs, news, features and events listings.
The information provided on PharmiWeb.com is designed to support, not replace, the relationship that exists between a patient/site visitor and his/her physician.