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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: Consultant / Specialist

Location: United Kingdom

We are looking for Senior Regulatory CMC Consultant to develop key initiatives proposed by the manufacturing part of the business. You will also be expected to provide regulatory advice to colleagues in the manufacturing organisation

Job Responsibilities

Development of regulatory strategy for key initiatives proposed by the manufacturing part of the business including sourcing changes on the API and Drug Product (requirements, timelines, specific market issues etc)
Provision of regulatory advice to colleagues in the manufacturing organisation
Creation and maintenance of regulatory plans
Interface with other regulatory departments within Global Regulatory Affairs
Responding to agency questions as required
Identifying improvement opportunities for CMC Regulatory processes, policies and systems
Providing feedback on progress and challenges to key stakeholders
Contribute to the maintenance of global CMC regulatory intelligence
May contribute to process improvement and/or regulatory intelligence projects

Skills and Requirements

Minimum 5 years CMC experience
Good written and oral communication and networking skills
Be aware of the contents of a marketing authorisation application
Demonstrate team working and effective time management skills
Ability to efficiently interact with customers and senior stakeholders as required

To Apply

Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

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