Informacje o stanowisku

For our Client, one of the biggest Pharmaceutical Companies worldwide we are looking for a Senior Manager, EMEA Regulatory Leader. The successful candidate will lead the EMEA Regulatory Affairs Strategy for a portfolio of diverse products, in close cooperation with the global and regional project teams and direct reports. The ideal candidate will bring to this role a high level awareness of the EU and broader EMEA regional regulatory environment, including Central/MRP/national procedures, issue management and portfolio optimization.

If you have relevant experience and would like to participate in the process, apply for this role.

What we expect

• University degree - medical or paramedical (pharmacy, biology, veterinary etc.), or equivalent by experience,
• Fluent English,
• Broad regulatory experience in drug development and commercialization. As this function is responsible for a broad portfolio of established products additional experience with late life cycle management & issue management will be an advantage.,
• Experience with EU regulatory procedures (CP, DCP/MRP, referrals & national),
• Experience in working in project teams and/or a matrix organization,
• Significant experience with people management will be a plus,
• Excellent oral and written communication skills,
• The ability to work successfully within a collaborative team environment and as an individual contributor and decision maker within a cross-functional remote organization.

Employment agency entry number 47

this job offer is intended for people over 18 years of age

What we offer

• annual performance-based bonus,
• opportunity to work with a leader in the pharmaceutical industry,
• a tangible impact on regulatory processes and the development of innovative products,
• additional leave benefits (e.g., bereavement leave),
• comprehensive medical care and life insurance,
• employer-sponsored retirement plan.

Your tasks

• Strategic regulatory input in Post-approval and Life cycle management including Portfolio optimization and Issue management,
• Liaising and negotiating with Regulatory Agencies, external partners and Local Operating Companies,
• Advise teams on required documents and processes to support Regulatory Agency contacts, submission and maintenance activities,
• Understand the competitive landscape, e.g., views of HA, regulatory precedents, labelling differences and therapeutic area issues,
• Ensure compliance and alignment with regulatory requirements and company processes.

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