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.
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
- hybrid work model (office in Warsaw)
- company car
- additional leave benefits (e.g., bereavement leave)
your tasks
implementing the regional regulatory strategy and submission plans, in alignment with R&D, regional, and local business objectivesrepresenting the region and collaborating with global regulatory teams to develop and execute regulatory strategies for productsadvising product teams on regional and local requirements, as well as the impact of supply chain decisions on regional registrationsmanaging regional working groups to ensure the achievement of product objectives and coordination of activities with global teamscollaborating with local operating companies and regulatory authorities in preparing submissions and negotiating product labelingmanaging the preparation of registration documentation and working closely with regional and global teamswhat we expect
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 developmentpharmaceutical regulatory experience in at least one major geographic region, with prior global regulatory exposureproven ability to manage multiple projects independently, with strong verbal and written communication skillsability to work in a multi-cultural, matrix environment and handle flexible hours for cross-time zone communicationexcellent English communication skillsexperience in leading project teams and demonstrated project management abilitiespreferred :
experience in APAC, LATAM, or non-EU countriesstrong knowledge of regulations and guidelines related to drug development and registrationdemonstrated contribution to drug development projects and strategy implementationother :
occasional travel (less than 10%)Employment agency entry number 47
this job offer is intended for people over 18 years of age
