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The Steely Group
http://www.thesteelygroup.com
http://www.thesteelygroup.com
The role of Regulatory Affairs is to develop innovative global registration strategies that advance our client’ s pipeline products through approval in US, EU, and other regions.
The Senior Manager, Regulatory Affairs will lead and execute strategy and tactics for the global development team, and support the Senior Vice President, Regulatory Affairs in the development of sound global regulatory registration strategies. This role is located in Cambridge, MA.
Key Responsibilities:
Requirements / Qualifications:
Tracey Goldthwaite
Senior Manager, Regulatory Affairs
Cambridge, MA 02142
Posted: 02/08/2021
2021-02-08
2021-04-04
Employment Type:
Direct Hire
Job Category: Clinical: Regulatory
Job Number: 2763
Job Description
The role of Regulatory Affairs is to develop innovative global registration strategies that advance our client’ s pipeline products through approval in US, EU, and other regions.
The Senior Manager, Regulatory Affairs will lead and execute strategy and tactics for the global development team, and support the Senior Vice President, Regulatory Affairs in the development of sound global regulatory registration strategies. This role is located in Cambridge, MA.
Key Responsibilities:
- Develop and implement regulatory plans and strategies for multiple products
- Lead, author, review, and QC of regulatory documents provided by other functions for submission
- Prepare and execute regulatory submissions for IND/CTA/NDA/MAA/PSP, briefing books, regulatory documents, and responses to Health Authority inquiries
- Coordinate with teams and consultants to address any inquiries from Health Authorities
- Manage and keep track of timelines for regulatory submissions related to commitments and responses to HA inquiries
- Develop labeling and review promotional materials as assigned
- Maintain thorough current knowledge of regulatory requirements; stay abreast of developing regulatory landscape that may affect products/projects
- Develop procedures to support the regulatory affairs department
- Perform other duties as necessary and assigned by the Senior Vice President, Regulatory Affairs
Requirements / Qualifications:
- Bachelor’ s degree in health related field or advanced science degree (PhD, PharmD, MD, MSc) (preferred) and at least 5 to 6 years industry or relevant experience
- Experience with US and EU filings including INDs, CTAs, NDAs, BLAs, and MAAs; FDA’ s CDER, CBER, and CDRH.
- Ability to act as primary contact with Health Authorities
- Must have in-depth knowledge of regulatory requirements, including ICH and regional requirements and have an understanding of current global and regional trends in regulatory affairs and ability to assess the impact of these requirements to the business
- Must be capable of developing and implementing regulatory strategies and of managing negotiations with Health Authorities
- Thorough scientific knowledge, understanding of regulatory policy, GCP, and ICH guidelines
- Good leadership, organization, problem-solving & communication skills
- Proficiency on key operations systems, including eCTD submissions software, RIM software and electronic gateway submissions, a plus
- Ability to manage priorities and workflow, managing multiple projects and meeting deadlines
Meet Your Recruiter
Tracey Goldthwaite
Senior Vice President
Tracey spearheads the firm’s Commercial practice and focuses on identifying and placing individuals in leadership roles within Global Marketing, Medical Affairs, New Product Planning, and Patient Advocacy and Engagement, to name a few. With 25 years of experience, she also plays a key role in the Clinical Staffing practice, recruiting top talent of all levels for positions in our core areas including Clinical Operations and Development, Regulatory Affairs, Pharmacovigilance and Program Management.