Jobs

• Support the development of regulatory strategies and plans to advance Spark products through the regulatory review and approval process globally.
• Prepare for and attend as needed meetings with regulatory authorities
• Anticipate regulatory obstacles and emerging issues, including changing regulations, throughout the product lifecycle and develop solutions with other members of regulatory and related teams.
• Evaluate proposed nonclinical, clinical, and manufacturing changes for regulatory filing strategies.
• Participate in the development & implementation of new regulatory policies, processes, systems, and SOP’s and train key personnel on them.

10%  Other projects and duties as may be required

Requirements: 

• Bachelor’s degree in Life/Health Sciences required; advanced degree preferred.
• Minimum of 5 years in Regulatory Affairs;
• Minimum 1-year management experience;
• Comprehensive knowledge of applicable regulations, including GCPs, GMPs and GLPs;

Technical Experience and Skills

• Experience in a relevant area of biologics/ vaccines and or gene therapy product development; experience in rare disease development desirable.
• Direct experience in interfacing with relevant regulatory authorities;
• Experience in interpretation of regulations, guidelines, policy statements, etc.;
• Experience and knowledge in the preparation of major regulatory submissions and supportive amendments or supplements, including INDs, BLAs, CTAs, MAAs for biologics/gene therapy. Products.

Managerial Experience and Skills

• Ability to represent the RA in project teams, committees, including the ability lead and influence project teams, committees, etc. to attain group goals;
• Supervisory/mentoring experience, including, prior experience coaching and supervising direct reports;
• Strong interpersonal skills with the ability to work effectively with regulatory, medical, scientific, manufacturing, legal, marketing functional areas;

Compentencies:

• Knowledge of the drug development process, with a focus on IND/CTA and NDA/BLA/MAA processes.
• Demonstrated experience in preparing new IND submissions.  Experience with BLA submissions is desirable.
• Excellent writing skills with an ability to write detailed information for submissions.
• Excellent ability to read, analyze and interpret technical documents, technical procedures and government regulations.
• Prepare and deliver effective presentations for external and internal audiences.
• Knowledge of computers and appropriate software packages. Experience with electronic submissions preferred.
• Ability to handle multiple tasks and strong attention to detail.
• Excellent interpersonal communication and organizational skills.
• Successful performance in a high-intensity work environment.
• Knowledge of regulatory history, guidelines, policies, standards, practices, requirements and precedents.
• Current knowledge and understanding of GxPs (GCPs, GLPs, GMPs) and ICH guidelines as well as FDA, international, and, if applicable, local regulations.
• Current knowledge and understanding of Ethical guidelines of clinical research and the regulatory process.

Learn more here