Regulatory Affairs & Safety Manager
We are Reckitt
About the role
Regulatory Affairs & Safety Manager will be responsible for ensuring full regulatory compliance of OTC products, managing registration and lifecycle processes, and developing advocacy strategies that support the company’s OTC portfolio and shape the external environment. This role combines deep regulatory expertise with proactive engagement of external stakeholders, industry associations, and regulatory bodies.
Your responsibilities
Regulatory & Safety
- Lead and manage the full regulatory lifecycle of OTC products, including registrations, variations, renewals, withdrawals, and maintenance.
- Prepare, submit, and follow up on regulatory documentation in line with national and EU requirements (including OTC categorization and OTC – GSL switch processes).
- Ensure regulatory compliance of product labels, artwork, claims, and promotional materials for OTC products.
- Monitor evolving regulatory requirements impacting OTC products and provide timely impact assessments.
- Collaborate cross-functionally with Professional Marketing, Marketing, Quality, Supply Chain, and Legal to support compliant business operations.
- Provide critical review of all projects proposed by Global/local business teams ( including NPD’s , claims)
- Actively engage in preparation of local innovation pipeline
- Lead cross-functional project teams for new product launches, regulatory changes, lifecycle updates, and advocacy initiatives.
- Provide strategic regulatory input for portfolio planning, including opportunities for switches, category extensions, and risk assessments
Advocacy & External Engagement
- Develop and implement advocacy strategies to support the OTC portfolio and influence regulatory and legislative frameworks.
- Represent the company in industry associations and working groups
- Engage with regulatory authorities and governmental bodies (e.g., Ministry of Health, Medicines Agency, GIF, GIS etc) to shape policy and regulatory direction.
- Monitor legislative developments, draft company positions, and lead responses to public consultations in co-operation with local Associations
- Work closely with Professional Marketing to build strong relationships with key opinion leaders, scientific experts, and patient organizations in support of policy‑shaping initiatives.
- Provide strategic regulatory insights for OTC -GSL switch projects, market access considerations, and competitive analyses.
- Challenge status quo for Regulatory
The experience we're looking for
- Master degree in medicine, pharmacy or natural science
- > 5 years experience as Regulatory Manager dedicated to medicinal products
- Experience in Healthcare advocacy
- Fluent English and Polish
- Problem solving and decision making
- Self-drive and ownership
- Good communication skills with internal and external stakeholders
- Entrepreneurial thinking
- Good leadership skills
- Regulatory strategic thinking
- Stakeholder management
What we offer
Equality
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