Senior Manager, Global Regulatory Affairs (Cell and Gene Therapy)
Remote - United States
We are seeking candidates with strong global Regulatory Affairs experience to serve as the Senior Manager Regulatory Affairs and 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.
- 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 drugs.
- Assist with the development and full maintenance of regulatory submission 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.
- Plan, prepare, and deliver high-quality regulatory files supporting submissions
- Develop responses to Regulatory Authorities with Regional Regulatory Affairs support and key stakeholders
- 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.
- A strong understanding of advanced therapy products development within Cell and Gene Therapy is strongly desired.
- Demonstrates problem-solving ability with the ability to analyze risk and make appropriate recommendations and decisions.
If interested in learning more, please contact Bria Gaber at (646) 430-1191 or email@example.com.