Director, Regulatory Affairs

02138, Cambridge
Mar 05, 2019
Required Education
Bachelors Degree
Position Type
Full time

This position is with a clinical stage biopharmaceutical company based in Cambridge, MA focusing in the treatment of autoimmune disease. This position reports to the Head of Regulatory Affairs. 

Main Accountabilities
• Independently perform and manage day-to-day product registration operations and ensure timely
completion of the registration tasks assigned, in compliance with local applicable laws, regulations,
guidelines, and policies and SOPs.
• Assist in the development of product registration strategy and action plan as well as regulatory affairs
activities assigned.
• Draft product registration strategy plan for review and approval
• Compile registration dossier and prepare other regulatory documents (e.g., package insert, packaging
components) and ensure timely regulatory submission upon internal review and approval.
• Coordinate internal departments in product registration process
• Communicate with regulatory agencies/institutes (e.g., FDA, NICPBP) on product registration.
• Timely /closely monitor regulations and review process for ensuring the data presented fully represent
what is practically required and the constantly changing regulations to be followed. Meet or accelerate
Regulatory milestones.

Role related Qualifications/ Skills:
• 7 or more years of pharmaceutical industry experience in R&D, Regulatory or related functions, with
at least 5 years working in regulatory affairs
• Bachelor degree (minimum), MS, PharmD or PhD highly preferred
• Experience with least one major marketing application (IND/NDA/BLA/MAA/JNDA etc…), or extensive
experience with late stage development.
• Self-motivated to achieve challenging goals.
• Demonstrated communication skills.

Knowledge, Skills and Other Experience
• Strategic
• Solid knowledge and understanding of complex medical and scientific subject matter as well as
evolving regulatory policy and guidance
• Direct interaction/negotiation with regulatory authorities (e.g. CFDA, FDA, EMA)
• Properly maintain all regulatory documentation.