Senior Manager Regulatory Affairs Regional Strategy Implementation

3 tygodni temu


Warszawa, Mazovia, Polska Randstad Polska Sp. z o.o. Pełny etat
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.

Senior Manager Regulatory Affairs Regional Strategy Implementation

Nr ref.: 485/1/2025/AT/259401/jobs.pl Warszawa (mazowieckie)

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 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

What 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 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

  • Warszawa, Mazovia, Polska Randstad Polska Sp. z o.o. Pełny etat

    We are looking for an experienced Senior Regulatory Affairs Professional to support the implementation of regional regulatory strategies for pharmaceutical products at various stages of their lifecycle. This role involves close collaboration with global and regional teams to effectively execute regulatory submission plans, support product approvals, and...


  • Warszawa, Mazovia, Polska Randstad Pełny etat

    Regulatory Affairs Manager/Senior Manager in Global LabelingWe are seeking a highly skilled Regulatory Affairs Manager/Senior Manager to join our team at {company}. This individual will be responsible for ensuring the quality of primary and derived labeling documents, providing support for these documents, and contributing to the global labeling strategy.Key...


  • Warszawa, Mazovia, Polska Randstad Polska Sp. z o.o. Pełny etat

    Job OverviewWe are looking for an experienced Senior Regulatory Affairs Professional to join our team and support the implementation of regional regulatory strategies for pharmaceutical products at various stages of their lifecycle.This role involves closely collaborating with global and regional teams to effectively execute regulatory submission plans,...


  • Warszawa, Mazovia, Polska Randstad Polska Sp. z o.o. Pełny etat

    Step into a pivotal role as Manager, Regulatory Affairs and contribute to the global development and lifecycle management of groundbreaking pharmaceutical products. As a key member of team, you will lead the development and execution of global CMC regulatory strategies, ensure compliance with regulatory requirements, and represent Global CMC Regulatory...


  • Warszawa, Mazovia, Polska Randstad Polska Sp. z o.o. Pełny etat

    We are seeking a highly skilled Regulatory CMC Manager to play a vital role in shaping global regulatory strategies for innovative pharmaceutical products. In this position, you will lead the preparation of regulatory dossiers, collaborate with cross-functional teams, and provide expert guidance to ensure compliance and successful product development. This...


  • Warszawa, Mazovia, Polska Randstad Polska Sp. z o.o. Pełny etat

    as Manager, Regulatory Affairs Established Products, you will be responsible for the regulatory support of a portfolio of established oncology and internal medicine products. Your objective will be to ensure compliance with regulatory requirements and to implement the global regulatory strategy for post-approval products.Regulatory Affairs Established...


  • Warszawa, Mazovia, Polska Randstad Polska Sp. z o.o. Pełny etat

    Job DescriptionAs a Senior Regulatory Affairs Professional, you will play a crucial role in supporting the implementation of regional regulatory strategies for pharmaceutical products at various stages of their lifecycle.You will be responsible for closely collaborating with global and regional teams to effectively execute regulatory submission plans,...

  • Regulatory Affairs Senior

    2 tygodni temu


    Warszawa, Mazovia, Polska Randstad Polska Sp. z o.o. Pełny etat

    For our Client, one of the biggest Pharmaceutical Companies worldwide, we are looking for a Regulatory Affairs Senior / Specialist in Submission Publishing who will be responsible for executing the electronic publishing of complex regulatory submissions for national, regional and global regulatory agencies and operating companies in both eCTD and non-eCTD...


  • Warszawa, Mazovia, Polska Randstad Polska Sp. z o.o. Pełny etat

    Regulatory CMC ManagerWe are seeking a highly skilled Regulatory CMC Manager to play a vital role in shaping global regulatory strategies for innovative pharmaceutical products.About the RoleIn this position, you will lead the preparation of regulatory dossiers, collaborate with cross-functional teams, and provide expert guidance to ensure compliance and...


  • Warszawa, Mazovia, Polska Randstad Pełny etat

    **About the Role:**We are seeking a highly skilled Regulatory Affairs Senior/Specialist to join our team at Randstad. As a key member of our team, you will be responsible for executing the electronic publishing of complex regulatory submissions for national, regional, and global regulatory agencies and operating companies in both eCTD and non-eCTD format.The...


  • Warszawa, Mazovia, Polska Randstad Pełny etat

    **Job Title:** Manager, Regulatory AffairsContribute to Global Development and Lifecycle ManagementYou will lead the development and execution of global CMC regulatory strategies, ensuring compliance with regulatory requirements and representing Global CMC Regulatory Affairs in cross-functional and external collaborations.About This Opportunity:This is an...


  • Warszawa, Mazovia, Polska TN Poland Pełny etat

    Regulatory Affairs Specialist Job DescriptionWe are seeking a highly skilled Regulatory Affairs Specialist to join our team in Warsaw, Poland.Key Responsibilities:Prepare and submit regulatory documents, CTA packages, and submissions in assigned countries to ensure high quality standards.Coordinate regulatory timelines and deadlines for all assigned projects...


  • Warszawa, Mazovia, Polska Randstad Polska Sp. z o.o. Pełny etat

    Job Overview:Our client, a leading pharmaceutical company, is seeking a Regulatory Affairs Senior/Specialist in Submission Publishing. The successful candidate will be responsible for executing the electronic publishing of complex regulatory submissions for national, regional, and global regulatory agencies and operating companies in both eCTD and non-eCTD...


  • Warszawa, Mazovia, Polska ManpowerGroup Sp. z o.o. Pełny etat

    We are seeking a highly skilled Regulatory Affairs Manager to lead the development and maintenance of primary labeling for assigned compounds. This role requires strong leadership skills, as well as expertise in pharmaceutical regulatory guidelines.Key Responsibilities:Develop and maintain primary labeling documentsEnsure compliance with worldwide regulatory...


  • Warszawa, Mazovia, Polska POLPHARMA S.A. Pełny etat

    Polpharma S.A. is a leading pharmaceutical company that seeks an exceptional candidate to fill the position of Regulatory Affairs Manager - CHC Team Lead. This role requires a highly skilled individual with experience in managing regulatory affairs teams in leading Pharma CHC, Consumer Healthcare or FMCG companies.Key Responsibilities:Team Leadership:...


  • Warszawa, Mazovia, Polska Randstad Polska Sp. z o.o. Pełny etat

    Join one of the largest pharmaceutical companies worldwide as a Regulatory Affairs Director (CMC) and play a pivotal role in shaping the future of global regulatory strategies for pharmaceutical products. This is an exciting opportunity to lead high-performing teams, drive strategic initiatives, and collaborate with global leaders to ensure compliance,...


  • Warszawa, Mazovia, Polska Randstad Pełny etat

    Job SummaryA highly skilled Regulatory CMC Manager is sought to play a vital role in shaping global regulatory strategies for innovative pharmaceutical products. This individual will lead the preparation of regulatory dossiers, collaborate with cross-functional teams, and provide expert guidance to ensure compliance and successful product development.Key...


  • Warszawa, Mazovia, Polska ManpowerGroup Sp. z o.o. Pełny etat

    Our client is a leading pharmaceutical company seeking an experienced Regulatory Affairs Publishing Specialist to join their team.The successful candidate will be responsible for executing the electronic publishing of moderate to complex regulatory submissions for national, regional, and global regulatory agencies and operating companies in both eCTD and...


  • Warszawa, Mazovia, Polska ManpowerGroup Sp. z o.o. Pełny etat

    ManpowerGroup Sp. z o.o., a global leader in the employment services industry, is seeking a highly skilled Regulatory Affairs Specialist to join our team. With over 70 years of experience and operations in 82 countries, we are committed to providing our clients with top-notch recruitment solutions.Job SummaryWe are looking for an experienced Regulatory...


  • Warszawa, Mazovia, Polska Randstad Pełny etat

    we are looking for a Senior Manager, Global Labelling to be responsible for the labelling strategy for pharmaceutical products in international markets. The role requires close collaboration with global and regional teams and subject matter experts to ensure documentation is in line with regulatory requirements and business strategy.the incumbent will manage...