Similar posts
Associate Director Regulatory CMC
- Permanent
- CMC
- United Kingdom
This vacancy has now expired. Please see similar roles below...
ProClinical is advertising a vacancy for a Regulatory CMC Associate Director with a global biopharmaceutical company. The organisation focuses on developing treatments in the fields of oncology, cardiovascular & metabolic disease (CVMD) and respiratory fields, as well as actively participating in the fields of autoimmunity, neuroscience, and infection.
This position offers an exciting opportunity to work with an innovative company whose medicines are used by millions of patients worldwide. The Regulatory CMC Associate Director is responsible for the global CMC submission and approval of oncology biosimilars and post approval changes.
Job Responsibilities
- Lead submission and approval of oncology biosimilars in US and ROW by 2020 based on EMA approval
- Lead health authority interactions along with technical experts to facilitate approval
- Post approval regulatory strategic planning, execution and interactions
The Regulatory CMC Associate Director possesses strategic leadership skills, understands regional (US or EU) and/or global regulatory science and overall drug/biologic development processes and strategies. Experience and knowledge of the oncology disease area is an important enabler to being able to influence cross-functional discussions with Product Development Teams (PDT) and relevant internal and external stakeholders.
To Apply
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical and medical device companies.
#LI-PD1
Related jobs
Highly Competitive Salary
Leeds, England
Proclinical is actively seeking a Senior Regulatory Consultant. This is a remote contract position.
Highly Competitive Salary
Leeds, England
Proclinical is seeking a Regulatory Affairs CMC Manager to support global commercial post-approval submissions. This is a remote contract position.
Highly Competitive Salary
Palo Alto, USA
Proclinical is actively seeking a Senior Manager for Regulatory Affairs. This is a remote permanent position.
Highly Competitive Salary
Boston, USA
Proclinical is seeking a Senior Regulatory Affairs Associate or a Regulatory Affairs Consultant with a strong background in CMC post-approval.
£65 - £75 per hour
London, England
Proclinical is partnering with a pharmaceutical organisation who are recruiting for an individual to join their team.
Highly Competitive
London, England
Proclinical is seeking a Regulatory CMC Associate for a 12-month contract role.
Highly Competitive
Mainz, Germany
Proclinical are recruiting for a Director Global Regulatory CMC Authoring to join a biotech organisation. This role is on a permanent basis and is located in Mainz.