Sr. Manager, Regulatory Affairs CMC | High-Growth Opportunity | Innovative Therapies | Top 20 Biopharma | Cambridge, MA area
This is a great opportunity for an experienced Regulatory Affairs CMC professional to join a very successful biopharma company focused on the development and commercialization of innovative high-potential new therapies. This is an exciting time as this company is going through a transitional phase, dedicated to continuing to invest heavily in R&D, and well-positioned for sustainable long-term growth/success – which lends itself to significant opportunity for you and a chance to really shine within this department in one of the company’s most exciting and highest-profile areas.
Attractive Features about this Company & Opportunity:
- Tremendous Growth Opportunity: Our client is going through an exciting transitional phase, and so you will have a great opportunity and platform here to shine and grow.
- 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.
- Excellent Compensation/Benefits Package: This company offers a very competitive compensation and benefits package.
- Innovative Therapeutics: Work on very exciting therapeutics and be an integral part of bringing innovative therapies with significant potential to market.
- Track Record of Success: Join a company with strong revenues, profits, cash & market cap that invests heavily in its R&D, and is well-positioned for sustainable long-term growth and success.
Responsibilities in a Nutshell:
- Responsibilities will include developing, coordinating and implementing global CMC regulatory strategies for assigned programs.
- Defining and optimizing global regulatory strategies pertaining to the development, registration, commercialization and lifecycle management of the company’s novel products.
- Serves as liaison to US and International Health Authorities for CMC related topics and issues.
- Maintains optimal CMC Regulatory Affairs effectiveness for ongoing development and lifecycle management activities through regulatory and operational excellence.
- 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.
- 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.
- Acts as an ambassador for the company’s Regulatory Affairs organization to influence and shape the external regulatory and policy environment.
Education & Desired Experience:
- Advanced scientific degree is preferred.
- 3+ years in a Regulatory Affairs CMC role experience working in the biotech/ pharmaceutical industry, or Government Health Authorities.
- Experience working one on one with the FDA/Health Authorities and leading agency meetings.
- Experience working on large submissions, tech transfers, regulatory strategy.
- 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: senior manager, manager, lead, Regulatory Affairs, CMC, plasma derived therapies, blood products, hematology, PDT, regulatory agencies, health authorities, Core Dossiers, CTAs, MAAs, NDS, Variations, small molecule, biologics