Team Leader – Regulatory Affairs CMC | Build Your Own Team | Innovative Therapies | Global Biopharma | Boston
Our client is a profitable and growing biopharma company focused on the development and commercialization of innovative high-potential new therapies in the rare disease space. In this exciting new opportunity as Director/Team Lead, you will come in and hire/build your own team of Regulatory CMC personnel and manage your own program within one the company’s most exciting and highest-profile therapeutic portfolio. This is an impactful and visible position where you will report to the Head of the department, work closely with a highly respected executive leadership team and create your own stamp/imprints on this department and organization.
ATTRACTIVE FEATURES ABOUT THIS COMPANY & OPPORTUNITY:
- Great Opportunity to Build Your Own Team: This is an exciting opportunity to come in and hire/build and directly manage your own team.
- Enjoy the Best of Both Worlds: Best of pharma and biotech: join a mid-sized company that has significant financial resources (i.e. cash, revenues, profits..), a strong appetite and for innovation and the perseverance/endurance to make the innovation happen (i.e. willing to significantly invest in its R&D spend and human capital too), and the company also offers a very entrepreneurial and agile work environment where decisions are made swiftly with minimal layers of management.
- Innovative Therapeutics: Work on very exciting therapeutics and be an integral part of bringing innovative new therapies to market.
- Track Record of Success: Join a Company that is well-positioned for sustainable long-term growth and has a track record of multiple discovery, development & FDA approval successes.
- Financial Strength: Join a company with strong revenues, profits, cash & market cap that invests heavily in its R&D.
- Very Competitive Compensation/Benefits: This company offers a very competitive compensation package and an extensive benefits package (LTI, 401k company contributions, employee stock purchase plan & much more).
RESPONSIBILITIES IN A NUTSHELL:
- Responsible for developing, coordinating and implementing global CMC regulatory strategies for assigned programs.
- Provides leadership and strategic guidance to your team by defining and optimizing global regulatory strategies pertaining to the development, registration, commercialization and lifecycle management of these therapies in the United States and international markets.
- Serves as the liaison to, and oversees the regulatory affairs relationship with, US and International Health Authorities for CMC issues.
- Maintains optimal CMC Regulatory Affairs effectiveness for ongoing development and lifecycle management activities through regulatory and operational excellence within their assigned team.
- Manages a team of direct reports (Associate Director / Sr. Manager levels), including performance evaluations, succession planning and ability for workforce planning.
- Provides guidance and oversight to CMC Regulatory personnel.
- Proactively contributes to the development and implementation of innovative CMC regulatory strategies in close collaboration with R&D and Commercial functions.
- Identifies and assesses regulatory and compliance risks associated with product development and life-cycle management activities.
- Interfaces with key R&D functions in the preparation, review and approval of CMC regulatory filings to support early and late stage development assets.
- Develops and fosters appropriate relationships with global regulatory agencies, especially the FDA and international regulatory agencies.
- Acts as an ambassador for the company’s Regulatory Affairs organization to influence and shape the external regulatory and policy environment.
- Serves as an active member of the CMC Regulatory Affairs leadership team to help influence and execute the operations and future strategy of the company’s R&D and Global Regulatory Affairs organization.
EDUCATION & DESIRED EXPERIENCE:
- Advanced scientific degree is preferred.
- At least 8 years of experience in global drug/biologics development at a biotech and/or pharmaceutical company.
- Minimum of 5 years in a Regulatory Affairs CMC role.
- People management experience (direct reports) is required, ideally having had experience hiring, performance evaluations, etc.
- Extensive knowledge of global regulatory requirements and demonstrated ability to function as the lead interface with global Regulatory Authorities.
- Experience in plasma-derived therapies or biologics is preferred.
Brian Skurka | Partner
P: 973-656-0220 x738
CORNERSTONE SEARCH GROUP – Pharma & Biotech Executive Search
Six Campus Drive | Suite 301 | Parsippany, New Jersey 07054 USA
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Keywords: Director, Leader, Regulatory Affairs, CMC, plasma derived therapies, blood products, hematology, PDT, regulatory agencies, Core Dossiers, CTAs, MAAs, NDS, Variations, small molecule, biologics