Senior Director Regulatory Affairs
Meet Life Sciences, Boston, MA, United States
Senior Manager – Regulatory Affairs Operations
Location - Cambridge, MA (Hybrid)
Oncology Biotech | Global Clinical Programs I’m currently supporting an innovative clinical-stage biotechnology company developing next-generation therapies in oncology. With multiple clinical programs advancing globally, the organisation is expanding its Regulatory Affairs Operations capability to support an increasing number of regulatory submissions and interactions with global health authorities.
This is an opportunity to join a highly collaborative regulatory team and play a key role in driving operational excellence across global regulatory submissions.
The Role Reporting into the Director of Regulatory Affairs Operations, you will provide hands‑on leadership across global regulatory submissions, supporting clinical development programs from early development through major filings.
You will work cross‑functionally with Regulatory Strategy, Clinical, CMC, and external partners to ensure submissions are delivered accurately and on time.
Key Responsibilities
Act as Regulatory Operations Lead for submission planning and execution
Coordinate and manage global regulatory submissions (IND, CTA, NDA and lifecycle updates)
Ensure regulatory documentation meets global eCTD submission standards
Support regulatory interactions with global health authorities
Manage submission tracking, document control, and regulatory correspondence
Provide expertise in publishing, QC, and regulatory technology platforms
Partner with internal stakeholders to ensure regulatory readiness across clinical programs
Contribute to the development of regulatory processes, standards, and best practices
Ideal Candidate Profile
Bachelor’s or Master’s degree in a life sciences discipline
~6+ years of experience in Regulatory Affairs within pharma or biotech
Strong experience with global regulatory submissions and eCTD publishing
Hands‑on experience with regulatory information management systems (e.g., Veeva RIM)
Experience supporting major submissions or lifecycle management activities
Strong cross‑functional collaboration and project coordination skills
Why This Role?
Join a high‑growth biotech with multiple clinical assets
Highly visible role working across global regulatory programs
Opportunity to influence submission strategy and operational processes
Competitive salary, bonus, equity and benefits package
#J-18808-Ljbffr
Oncology Biotech | Global Clinical Programs I’m currently supporting an innovative clinical-stage biotechnology company developing next-generation therapies in oncology. With multiple clinical programs advancing globally, the organisation is expanding its Regulatory Affairs Operations capability to support an increasing number of regulatory submissions and interactions with global health authorities.
This is an opportunity to join a highly collaborative regulatory team and play a key role in driving operational excellence across global regulatory submissions.
The Role Reporting into the Director of Regulatory Affairs Operations, you will provide hands‑on leadership across global regulatory submissions, supporting clinical development programs from early development through major filings.
You will work cross‑functionally with Regulatory Strategy, Clinical, CMC, and external partners to ensure submissions are delivered accurately and on time.
Key Responsibilities
Act as Regulatory Operations Lead for submission planning and execution
Coordinate and manage global regulatory submissions (IND, CTA, NDA and lifecycle updates)
Ensure regulatory documentation meets global eCTD submission standards
Support regulatory interactions with global health authorities
Manage submission tracking, document control, and regulatory correspondence
Provide expertise in publishing, QC, and regulatory technology platforms
Partner with internal stakeholders to ensure regulatory readiness across clinical programs
Contribute to the development of regulatory processes, standards, and best practices
Ideal Candidate Profile
Bachelor’s or Master’s degree in a life sciences discipline
~6+ years of experience in Regulatory Affairs within pharma or biotech
Strong experience with global regulatory submissions and eCTD publishing
Hands‑on experience with regulatory information management systems (e.g., Veeva RIM)
Experience supporting major submissions or lifecycle management activities
Strong cross‑functional collaboration and project coordination skills
Why This Role?
Join a high‑growth biotech with multiple clinical assets
Highly visible role working across global regulatory programs
Opportunity to influence submission strategy and operational processes
Competitive salary, bonus, equity and benefits package
#J-18808-Ljbffr