Regional CMC Consultant job in Surrey, England

First Name*

Last Name*

Email*

Phone Number*

Country*

Are you an employer or a jobseeker?*

Message

First Name*

Last Name*

Email*

Phone Number*

Country*

Are you an employer or a jobseeker?*

Message

First Name*

Last Name*

Email*

Phone Number*

Country*

Are you an employer or a jobseeker?*

Message

First Name*

Last Name*

Email*

Phone Number*

Country*

Are you an employer or a jobseeker?*

Message

Job type: Permanent

Discipline: CMC

Location: United Kingdom

This vacancy has now expired. Please see similar roles below...

An exciting opportunity has arisen for a Regional CMC Consultant to join a large pharmaceutical company. This pharmaceutical regulatory affairs job is an excellent opportunity to work for a global leader in the life sciences industry. The company has been established for more than 150 years and is a major supplier to the NHS.

Job Responsibilities

Manage initial and post approval submissions for Upjohn products in Developed Markets
Manage initial and post approval strategy (including timelines) and execution in alignment and partnership with key stakeholders (i.e. PGS, GRL, CRL, Labelling team, Submissions Management) to ensure a submission ready dossier.
Communicate changes to regulatory requirements and update the appropriate system in a timely manner
Support planning and monitoring activities, update timelines when necessary and communicate changes to the relevant partners
Author local submission components as needed
Ensure submission packages are reviewed against local CMC requirements for consistency and completeness
Liaise with the manufacturing sites for obtaining supporting documents as needed
Ensure thorough understanding and application of Upjohn RA procedures
Assist in ensuring internal regulatory processes and procedures are well documented
Identify and support efficiencies across the region through achieving consistency in initial and post approval strategies and its execution.

Skills and Requirements

Bachelor's degree or equivalent i.e. degree in Chemistry, Pharmacy, or a related life sciences.
MSc, MBA or PhD may be an advantage
Prior experience in the pharmaceutical or related industry in Regulatory Affairs, Conformance or Compliance
Experience in regulatory affairs or compliance preferably in human medicines - minimum 5 years of experience.
Demonstrated regulatory experience with a pharmaceutical company with proven examples of contribution.
Proven ability to manage Regulatory issues and consistently deliver to time, cost and quality standards.
Regulatory experience including knowledge of Europe submission product lifecycle management processes.

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

Senior Manager Regulatory Affairs

Salary

Highly Competitive Salary

Location:

Palo Alto, USA

Proclinical is actively seeking a Senior Manager for Regulatory Affairs. This is a remote permanent position.

Nick Walker

Apply

Consultant Regulatoty CMC

Salary

Highly Competitive Salary

Location:

Boston, USA

Proclinical is seeking a Senior Regulatory Affairs Associate or a Regulatory Affairs Consultant with a strong background in CMC post-approval.

Funmi Gbadamosi

Apply

Regulatory CMC Dossier Manager (remote)

Salary

£65 - £75 per hour

Location:

London, England

Proclinical is partnering with a pharmaceutical organisation who are recruiting for an individual to join their team.

Peter Duvall

Apply

Regulatory CMC Associate (hybrid)

Salary

Highly Competitive

Location:

London, England

Proclinical is seeking a Regulatory CMC Associate for a 12-month contract role.

Dracen Black

Apply

Director Global Regulatory CMC Authoring

Salary

Highly Competitive

Location:

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.