senior manager regulatory affairs regional strategy implementation.

For our Client, one of the largest Pharmaceutical Companies worldwide, we are looking for a Senior Manager, Regulatory Affairs Regional Strategy Implementation. This position resides within Global Regulatory Affairs and provides regional regulatory strategic implementation support for products in one or more therapeutic areas. The successful candidate will collaborate with Global and Regional Regulatory Leaders, functional area experts, and Local Operating Companies to implement and execute the company’s regulatory strategies for both marketed products and products under development, aligning with R&D, regional, and local business objectives.

This role operates within a matrix environment, requiring strong leadership skills to drive results. If you have relevant experience and would like to contribute to impactful regulatory strategies, we invite you to apply for this position.

• 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
• hybrid work model (office in Warsaw)
• company car
• additional leave benefits (e.g., bereavement leave)

• implementing the regional regulatory strategy and submission plans, in alignment with R&D, regional, and local business objectives
• representing the region and collaborating with global regulatory teams to develop and execute regulatory strategies for products
• advising product teams on regional and local requirements, as well as the impact of supply chain decisions on regional registrations
• managing regional working groups to ensure the achievement of product objectives and coordination of activities with global teams
• collaborating with local operating companies and regulatory authorities in preparing submissions and negotiating product labeling
• managing the preparation of registration documentation and working closely with regional and global teams

Education:

• 10 years of relevant experience (7 years in pharmaceutical regulatory) or Master’s/PharmD with 8 years of relevant experience (6 years in pharmaceutical regulatory) or PhD with 8 years of relevant experience (5 years in pharmaceutical regulatory)

Required:

• Extensive global regulatory affairs experience in drug development and commercialization, with experience in a therapeutic area and multiple phases of drug development
• Pharmaceutical regulatory experience in at least one major geographic region, with prior global regulatory exposure
• Proven ability to manage multiple projects independently, with strong verbal and written communication skills
• Ability to work in a multi-cultural, matrix environment and handle flexible hours for cross-time zone communication
• Excellent English communication skills
• Experience in leading project teams and demonstrated project management abilities

Preferred:

• Experience in APAC, LATAM, or non-EU countries
• Strong knowledge of regulations and guidelines related to drug development and registration
• Demonstrated contribution to drug development projects and strategy implementation

Other:

• Occasional travel (less than 10%)

Employment agency entry number 47

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