Associate Director, Regulatory Affairs CMC | Novel Therapies | Top 20 Biopharma | Boston area

Cornerstone Search Group
Published
April 8, 2020
Location
Greater Boston Area, United States
Category
Job Code
bcsBH2766csg
Contact Email
bskurka@cornerstonesg.com

Description

Associate Director, Regulatory Affairs CMC | Excellent Growth Opportunity | Novel Therapies | Top 20 Biopharma | Boston 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.  So this is a high-impact role where you will have a chance to really shine and serve as one of the go-to people within this department in one of the company’s most exciting and highest-profile areas.

Attractive Features about this Company & Opportunity:

  • Tremendous Growth Opportunity: This company is going through an exciting transitional phase, which will provide you with the opportunity to serve as a “go-to” person as well as a platform 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.
  • At least 5 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 (ideally leading) large submissions, tech transfers, regulatory strategy.
  • Experience in plasma-derived therapies or biologics is preferred.

Contact:

Brian Skurka | Partner

E: bskurka@cornerstonesg.com

P: 973-656-0220 x738

LinkedIn: https://www.linkedin.com/in/brianskurka1

CORNERSTONE SEARCH GROUP - Pharma & Biotech Executive Search

Six Campus Drive | Suite 301 | Parsippany, New Jersey 07054 USA

www.cornerstonesg.com

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Keywords: Associate Director, Leader, senior manager, Regulatory Affairs, CMC, plasma derived therapies, blood products, hematology, PDT, regulatory agencies, health authorities, Core Dossiers, CTAs, MAAs, NDS, Variations, small molecule, biologics

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