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EMEA Regulatory Affairs Manager

Employer
Planet Pharma Staffing Limited
Location
Switzerland (CH)
Salary
Competitive Salary in line with skills and experience
Start date
8 Dec 2021
Closing date
7 Jan 2022

View more

Discipline
Regulatory Affairs
Hours
Full Time
Contract Type
Permanent
Experience Level
Management

Job Details

Role – EMEA Regulatory Affairs Manager    

Location – EU Remote

Rate – Competitive (In line with skills and experience)

Type – Permanent

Purpose

For one of Planet Pharma’s global clients, we urgently seek a EMEA Regulatory Affairs Manager to join on a permanent basis. This role is a homebased position which can be based anywhere in Switzerland or Europe. In this role you will assess links between global, societal and economic trends; stakeholder concerns and regulatory issues and requirements.

Role

  • Participates in advocacy activities of a more advanced strategic nature
  • Develops and updates global, regional and multi-country regulatory strategy, and aligns regulatory strategies to organizational strategies
  • Provides guidance to integrate regulatory considerations into global product entry and exit strategy
  • Identifies regulatory pathways for initial product designs and provides input to internal stakeholders
  • Negotiates with regulatory authorities on complex issues throughout the product lifecycle
  • Establishes working relationships and interfaces with multiple government and non-government organizations having an impact on market access and distribution
  • Identifies the need for and manages the development and execution of new regulatory procedures and standard operating procedures
  • Develops and manages programs that train stakeholders on current and new regulatory requirements to ensure organization-wide compliance
  • Manages electronic (eCTD) and paper registration development

 

 

 

 

Qualifications 

  • A minimum of 5 years’ experience in Regulatory Affairs in the pharmaceutical industry
  • Experience across EMEA Regions
  • Experience in dealings with the EMA (scientific advice, orphan designation, PIPs) is an advantage
  • Well-versed in regulatory strategy, ICH and EMA guidelines

Interested? Apply now for immediate consideration or contact Michael Owusu-Ansah on +44 203 928 6631 – mowusu-ansah@planet-pharma.co.uk

We are an equal opportunities Recruitment Business and Agency. We welcome applications from all suitably qualified candidates regardless of their race, sex, disability, religion/belief, sexual orientation or age. Planet Pharma is an Employment Business providing Global Staffing services.

Company

Planet Pharma was founded by a dedicated team of professionals with extensive experience supporting the pharmaceutical, biotechnology, and device industries.

Our goal is to create an organization that strengthens the employer-employee dynamic by connecting clients with talent. This results in making staffing more personal and creating enduring, valuable relationships. We value communication with our clients and make it our priority to have the hiring process be as fast and successful as possible.

We leverage cutting-edge technology and flexible service delivery models that provide efficient, personalized solutions for your business.

Our global headquarters is in Northbrook, IL and branch offices are based across the United States and Europe.

Company info
Website
Telephone
+44 203 868 1000
Location
10 Greycoat Place
London
England
SW1P 1SB
United Kingdom

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