We are partnering with a
global pharmaceutical company
to appoint a
Senior Director Regulatory Affairs
to lead regulatory strategy and execution across a broad portfolio of
established, marketed products .
This is a senior leadership role with end-to-end accountability across
Regulatory Affairs, CMC, and Regulatory Operations , operating in a highly international environment and working closely with Manufacturing, Quality, and Supply Chain.
Key responsibilities
Lead global regulatory strategy and governance for marketed products
Oversee post-approval lifecycle management, including variations, renewals, and manufacturing transfers
Strengthen CMC regulatory oversight and health authority engagement
Lead and develop an international regulatory organisation
Act as a senior regulatory partner across technical and commercial functions
Background sought
Senior leadership experience within Regulatory Affairs in a global pharmaceutical setting
Strong exposure to
post-approval / lifecycle management
of marketed products
Sound understanding of CMC regulatory requirements (without being CMC-only)
Able to operate both strategically and hands‑on, particularly during transition periods
Hybrid working is supported, with an expectation of on-site presence initially.
#J-18808-Ljbffr
global pharmaceutical company
to appoint a
Senior Director Regulatory Affairs
to lead regulatory strategy and execution across a broad portfolio of
established, marketed products .
This is a senior leadership role with end-to-end accountability across
Regulatory Affairs, CMC, and Regulatory Operations , operating in a highly international environment and working closely with Manufacturing, Quality, and Supply Chain.
Key responsibilities
Lead global regulatory strategy and governance for marketed products
Oversee post-approval lifecycle management, including variations, renewals, and manufacturing transfers
Strengthen CMC regulatory oversight and health authority engagement
Lead and develop an international regulatory organisation
Act as a senior regulatory partner across technical and commercial functions
Background sought
Senior leadership experience within Regulatory Affairs in a global pharmaceutical setting
Strong exposure to
post-approval / lifecycle management
of marketed products
Sound understanding of CMC regulatory requirements (without being CMC-only)
Able to operate both strategically and hands‑on, particularly during transition periods
Hybrid working is supported, with an expectation of on-site presence initially.
#J-18808-Ljbffr