EU Regulatory Manager job in Basel, Switzerland

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First Name*

Last Name*

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Phone Number*

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Are you an employer or a jobseeker?*

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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

Job type: Permanent

Discipline: Project Manager

Location: Switzerland

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

An exciting opportunity has arisen for an EU Regulatory Affairs Manager in Switzerland. In this role you will be responsible for leading and implementing regulatory activities for assigned projects.

Job Responsibilities

Coordinate, prepare or review regulatory submissions for all projects to include but not limited to new MAAs, variations and other associated life cycle maintenances submissions.
Manage and facilitate all life cycle maintenance activities with partner CROs
Review change controls for the regulatory team
Help with regulatory related questions and complaints
Lead the artwork approval process of printed packaging components to meet packaging design and legislation requirements for each new product, new packs or changes to existing packaging
Review labelling (SPC, PIL and Labelling) for compliance against current EU guidelines and standards
Liaise with relevant internal and external suppliers/departments to assist with implementation being achieved effectively and on time.
Maintain relationships with print suppliers and the artwork studio
Coordinate review & approval of EU promotional material
Maintain current knowledge base of existing and emerging regulations, standards or guidance documents
Follow company policies and procedures
Collaborate with team to establish and meet targets and timelines
Help generate SOPs and Work instructions
Identify, design and implement process and system improvements

Skills and Requirements

University degree in life science, pharmacy, pharmacology, medicine or related discipline and possible higher degree
Experience in filing new registrations via CP/DCP
Experience in variations and life cycle management through European procedures (MRP/ National)
Experience in Labelling & artwork management
Experience in project management
Literate in Microsoft Office applications
Independent, reliable and communicative personality who can deliver high-quality work even under pressure and handle several projects simultaneously

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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