Associate Director International Regulatory Affairs

Job Ref: J25219
Sector: Clinical
Sub-sector: Pharmaceuticals
Date Added: 29 January 2018

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The Role:

Responsible for strategic, tactical and operational regulatory direction and guidance for product and disease state communications and activities for products in the International/EU area. Manage and conduct the regulatory affairs aspects of review and approval of International/EU product communications and materials, including advertising and promotional materials and marketing activities.

Key Responsibilities:

Serve as expert on International/EU regulations and requirements governing product promotion and related communications, including disease-state and training materials

In collaboration with Commercial, Medical, and Legal, provide regulatory leadership to ensure that regulatory requirements are integrated in product and disease-state communications within the EU/International area

Function as local-country Regulatory Affairs representative for review and approval of materials for countries/territories as assigned, in accordance with local country requirements and procedures

Provide oversight and guidance to affiliates and/or consultants for local country review of communication materials, in accordance with local country requirements and procedures

Contribute to the development of regional plans to maximize regulatory success for product communications towards achievement of program objectives and effectively communicate objective assessments of the likelihood of success of these regulatory strategies

Provide guidance and input for development projects reflective of promotional considerations

Responsible for the creation and revision of the International/EU procedures related to product and disease-state communications' review and approval

Partner with business stakeholders to develop and/or improve processes and conduct training as needed

Collaborate with operations functions and cross-functional colleagues to assess and optimize use of electronic review and archiving tools

Support labelling review, approval, and implementation activities including serving as a member of the Labelling Working Group

Skills and Experience required:

BSc. Advanced scientific related degree preferred

Extensive pharmaceutical industry experience, with demonstrated experience specific to advertising and promotion compliance in the EU. This is inclusive of thorough regulatory experience or a solid combination of regulatory and/or related experience

Thorough knowledge of regulations and guidance's governing drugs and biologics in all phases of development in the EU (focus on Europe and marketed products), with a good understanding of basic regulatory requirements in emerging markets

Ability to speak and read German (required) and French (preferred)

If you are interested in this role or would like to have a confidential career discussion regarding other Regulatory Opportunities. Please contact me: or +441753 589626

The recruiter has stated that all applicants for this job should be able to prove they are legally entitled to work in the EU/UK. SRG is a trading name of Science Recruitment Group Ltd an Employment Business/Agency.