2 Head of Regulatory Affairs Oncology Jobs in Cambridge, MA
Scientific Search is Hiring a Head of Regulatory Affairs Oncology Near Cambridge, MA
Responsibilities
- Leads global strategic and operational planning, management, support and execution of regulatory activities.
- Builds and manages strong relationships with cross-functional internal colleagues, as well as between the regulatory team and regulatory agencies, external CROs, regulatory consulting groups, and other third parties.
- Defines strategies and coordinates the execution of regulatory submissions including, but not limited to: Investigational New Drug applications, New Drug Applications and equivalent international filings.
- Serves as a primary liaison to US FDA, EMA, and other key market Health Authorities, driving interactions and overseeing Health Authority meeting preparation throughout the organization.
- Manages, coaches, and mentors direct reports.
- Bachelor’s degree in a scientific discipline is required, advanced degree is a plus with a minimum of 10 years of progressively increasing experience in a pharmaceutical or biotechnology organization including significant experience in a Regulatory Affairs leadership role.
- Oncology experience required.
- Regulatory CMC and CDx experience are preferred
- In-depth knowledge of relevant regulatory guidelines and requirements, with a focus on the US and EU
- Proven record of success in gaining regulatory approval through relationship building with global health authorities; experience with INDs, NDAs, CTAs, and post-marketing/life cycle management (e.g. variations, renewals, labeling)
We’d love to see your resume, but we don’t need it to have a conversation. Send us an email to Tom@scientificsearch.com.
Job Summary
Full Time
Ambulatory Healthcare Services
$248k-345k (estimate)
06/10/2024
07/20/2024
scientificsearch.com
CHERRY HILL, NJ
25 - 50
1983
ALLEN C ZECHOWY MDPHD
<$5M
Ambulatory Healthcare Services
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About Scientific Search
Scientific Search is a leader in the placement of technology professionals. Our technology areas of specialization include engineering, pharmaceutical & biotech, market research and information technology. Our client base is predominately centered in the corridor stretching from Philadelphia to New Jersey and the New York metropolitan area. We do, however, conduct a significant portion of our business outside of our primary market territory, both regionally and nationally. We are a full service employment agency offering multiple staffing options. From contract placements to direct placements ...and everything in between, Scientific Search works with employers and technology professionals to find the perfect solution. Scientific Search was founded in 1983 and has been providing recruiting and staffing excellence for twenty years. We have survived and excelled through a combination of hard work, knowledge and integrity. We are the firm that leading employers depend on to solve their staffing needs, and technology professionals trust to find challenging, rewarding positions. To learn more about Scientific Search, please visit our website at www.scientificsearch.com or call 856-761-0900.
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