Senior Regulatory Affairs Product Specialist

Warsaw Poland Hybrid (1 day per week in-office)

At Theramex we are driven by a clear purpose by improving the lives of women around the world through innovative and accessible healthcare. As one of the fastest growing global specialists in Womens Health we combine the agility of a scale up with the impact and ambition of a private equity backed organisation. Here your work translates into real world outcomes - shaping portfolios influencing strategic direction and driving meaningful change for patients. Youll join a collaborative high performing team that values expertise encourages fresh thinking and empowers people to lead with ownership. If you are motivated by purpose growth and the opportunity to make a lasting difference Theramex offers a place where your contribution truly matters.

About you

• Advanced experience with practical European Regulatory Affairs including a good understanding of the following MA lifecycle activities within DCP MRP and National procedures (preferably also other than URPL):

  • postauthorisation variations impacting CMC Safety and Product Information

  • different submission strategies (e.g. single grouping SuperGrouping WorkSharing)

  • other RA activities such as renewals and PSURs/PSUSAs

  • CTD/eCTD documentation structure and lifecycle management

• Knowledge and understanding of the following areas European regulations and related guidance documents (e.g. management of documents submissions requirements):

  • regulatory submissions across different markets and procedures including the Centralised Procedure

  • Product Information authoring editing and management

  • CMC documentation requirements

  • CTD and eCTD authoring editing and lifecycle management

• Able to perform other Regulatory Affairs activities with team support (e.g. PASS PAMs Centralised Procedure submissions)

• Able to perform accompanying activities such as Artwork reviews/approvals and Prescribing Information preparation

• Good interpersonal skills and effective problemsolving capabilities

• Proactive adaptable and comfortable working across multiple projects while maintaining high standards

• High attention to detail with excellent organisational and timemanagement skills

• Excellent written and verbal communication skills in English and Polish

• Desirable degree in Pharmacy Biology Chemistry or a related discipline.

• Desirable experience working with distributor markets via thirdparty contractors.

• Desirable experience in planning and project management.

About the role

The Senior Regulatory Affairs Product Specialist serves as a key regulatory partner to the business providing strategic guidance and operational support across designated products and markets. The role ensures that regulatory objectives are fully aligned with business needs drives compliant and efficient lifecycle management activities and contributes to the successful execution of regulatory strategies across the product portfolio.

Key Duties and Responsibilities

• Preparation and submission of required regulatory packages for designated products/countries including variations and lifecycle activities

• Authoring/updating of key regulatory documentation including CTD components and Product Information and leading review of other technical documents to ensure regulatory compliance

• Development and implementation of regulatory strategy for required changes

• Act as the contact within the business for regulatory advice and support related to designated products

• Provide support and regulatory advice to key internal stakeholders including MS&T Quality Pharmacovigilance Supply and other teams

• Identification of any gaps in the regulatory documentation and conduction of any remediation necessary to achieve compliance

• Communication with external stakeholders including regulatory agencies CMOs and third party service providers

• Creation and maintenance of Regulatory Information Management systems and databases records and entries

• Support of creation and maintenance of SOPs working instructions describing regulatory and labelling processes and best practices to ensure compliance

What does our team say about life at Theramex

Having now been with Theramex for a few months Im really enjoying my time here. Right from the outset the onboarding experience induction and orientation have been brilliant and I already feel like I am making the most of opportunities to add value to the business in meaningful ways. Theramex has a friendly and supportive vibe and is a place where I feel supported and valued.

Umut Tarakcilar Senior Treasury Analyst

Why Join Us

• A fast-paced environment with broad exposure giving you opportunities to develop professionally - even outside your core area of expertise

• A culture that supports learning celebrates success and recognizes performance

• Opportunities for driven and talented professionals to contribute to our exciting journey

Apply Now!
Ready to make a meaningful impact in Womens Health Wed love to hear from you. Apply today and shape the future with Theramex.