Senior CMC Reg Manager job in Zürich, Switzerland

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

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

A leading pharmaceutical client is advertising a vacancy for a Senior CMC Reg Manager, based in their European office. The company's CMC team provides regulatory guidance to regulatory submissions across the EU, Switzerland, Balkans, Israel, and Russia. This is an exciting opportunity to join a large pharmaceutical company and work with local and global regulatory teams.

Job Responsibilities:

Provide regional/country, product and regulatory expertise, and clarification on regional CMC RA requirements.
Review the preparation of M2 and 3 CMC components of filings.
Manage regional CMC filings from marketing authorisation
Author and coordinate responses to questions across assigned products and countries.
Project Manage submissions and monitor status of applications.
Ensure CMC regional issues impacting the global regulatory strategy for proposed CMC filings are considered.
Provide guidance for regulatory assessments of change control requests.

Skills and Requirements:

Direct experience with EU and EM market applications - MAAs or variations.
CMC regulatory knowledge & experience.
Strong record of related experience within Regulatory Affairs.
Experienced in creation and execution of regional regulatory strategies.
Current knowledge and application of CMC hot topics and knowledge of EU/EM legislation and guidance for biotechnology products.
Demonstrable multitasking, project management, and execution skills.
Good interpersonal skills, including communication, presentation, persuasion, and influence.

Good organisational skills, including efficiency, punctuality, and collaboration in a team environment.
Proficiency with computer skills, such as MS Office.

To Apply:

Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.

In case you have difficulty in applying or if you have any questions, please contact Peter Duvall at or upload your CV on our website - www.proclinical.com.

A full job description is available on request.

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

Proclinical Staffing is an equal opportunity employer.

#LI-116788626_PD1

#RegulatoryAffairs

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.