Director/Leader, Regulatory Affairs Strategy | Innovative Therapies | New Business Unit - Exciting Biopharma | Boston
Our client is a fast-growing biopharma leader focused on the development and commercialization of innovative high-potential new therapies in the rare disease space. This is an exciting new opportunity within a new Business Unit where you will serve as the US and Global regulatory strategy lead for high-profile projects, provide global regulatory leadership and strategic guidance, key internal/external relationships, and manage other regulatory personnel. This is an impactful and visible position where you will report to the Head of the department and work closely with a highly respected executive leadership team.
ATTRACTIVE FEATURES ABOUT THIS COMPANY & OPPORTUNITY:
- Exciting Opportunity in New Business Unit: This is an exciting opportunity to join a new Business Unit within the organization in an impactful/influential role.
- Enjoy the Best of Both Worlds: Best of pharma and biotech: enjoy a very collaborative, intellectual and fast-paced/nimble work environment where decisions are made swiftly with minimal layers of management, while also being part of a 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).
- Innovative Therapeutics: Work on very exciting therapeutics and be an integral part of bringing innovative new cell therapies to market.
- Fantastic Hiring Manager: Report into a very highly-regarded and well-respected hiring manager/Department Head.
- 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.
- Excellent 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 and directing global regulatory strategies, objectives and policies pertaining to the development, registration, commercialization and lifecycle management of innovative therapies in the United States and international markets.
- Serves as the global regulatory affairs lead for one or more projects and includes leadership of the Global Regulatory Team composed of core regulatory support functions.
- Serves as the primary liaison to the US FDA and will provide support for regional and local regulatory affairs teams for interactions with international regulatory Agencies and Health Authorities.
- Provides proactive guidance and leadership to develop and implement innovative regulatory strategies in close collaboration with relevant R&D and Commercial functions.
- Leads Global Regulatory Team and represents Regulatory Affairs function on key internal program teams.
- Leads the tactical implementation of strategic regulatory plans for the creation and submission of regulatory documents, e.g., INDs, NDAs/BLAs, CTAs, MAAs, supplemental NDAs/BLAs.
- Designs and implements US regulatory strategies to obtain and maintain INDs and NDAs/BLAs, and to extend product registrations.
- Acts as the primary point of contact and interface with key R&D functions in the preparation, review and approval of regulatory filings to support early and late stage development assets.
- Supervises and provides guidance and oversight of assigned US and International Regulatory personnel/team members.
- Serves as an active member of the Regulatory Affairs Leadership team to help influence 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 of relevant experience in a Regulatory Affairs strategy role.
- Strong US and international/global regulatory affairs experience.
- Extensive knowledge of global regulatory requirements and demonstrated ability to function as the lead interface with global Regulatory Authorities.
Brian Skurka | Partner
E: firstname.lastname@example.org | 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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