Senior Manager, Global Regulatory Affairs

Senior Manager, Global Regulatory Affairs (Cell and Gene Therapy)

Remote - United States

Summary:

We are seeking candidates with strong global Regulatory Affairs experience to serve as the Regulatory Senior Manager to partner with the Global Regulatory Leaders to actively contribute with the development and implementation of global regulatory strategies for novel drugs; late-stage assets and other early-stage products. This Senior Manager will work collaboratively cross-functionally with the team and will have the opportunity to contribute to regulatory strategies that expedite development, maximize the probability of success, and mitigate risks.

Responsibilities/Skills:

• Provides regulatory support on global regulatory strategies on specific clinical development projects teams for groundbreaking gene therapy products.
• Prepare regulatory submissions independently and assisted on more complex submissions.
• Experienced with eCTD IND, CTA, NDA/BLA/MAAs submission preparation, and drafting.
• Maintain and develop regulatory submissions for breakthrough therapies and Orphan drug.
• Assist with the development and full maintenance of regulatory submssions tracking/archiving (EDMS).
• Strong knowledge of pertinent regulations in ICH regions.
• Collaborate with the teams towards common goals through development/approval challenges.
• Responsible for regulatory activities for assigned projects in line with US, European, ICH, and other applicable requirements to ensure compliance
• Strong ability to work and manage multiple projects at any given time.

Professional Qualifications:

• Bachelor of Science degree in Life Sciences or Biology or equivalent required; M.S. or Advanced degrees (Ph.D./PharmD) preferred
• A minimum of 8 years of relevant global regulatory industry experience in a biotech/pharmaceutical setting.
• Experience with eCTD IND, CTA, NDA/BLA/MAAs, Orphan Drug designations
• Strong understanding and interpretation of GxP protocols and ICH, FDA, & EMA guidelines and regulations to ensure compliance of requirements from healthy authorities.
• Working knowledge with document respiratory systems, i.e.: EDMS, CTMS, Veeva
• Scientific background with a strong understanding of advanced therapy product development; biologics product development is required.
• Recent experience within Rare Diseases/Orphan disease indications.
• Strong understanding of advanced therapy products development within Cell and Gene Therapy is strongly desired.

If interested in learning more, please contact Bria Gaber at (646) 430-1191 or bria.gaber@investigo-us.com.