About the role
The Regulatory Affairs Manager ensures compliant market access for diverse portfolios (medicines, devices, cosmetics, foods) by leading product registration, labeling, and claims aligned with commercial goals. They maintain ongoing compliance, manage health authority interactions, and oversee submissions and inspections. Serving as a key strategic partner, they collaborate cross-functionally with marketing, supply chain, and quality teams while coaching junior staff. Externally, they build strong relationships with regulators and industry bodies to facilitate approvals. Finally, they monitor regulatory trends, mitigate risks, and drive continuous improvement to support successful product launches and lifecycle management.
Key responsibilities
Product Lifecycle & Launch Management: Lead the end-to-end regulatory process for new product launches and lifecycle maintenance (NPD & Line Extensions), utilizing systems like Veeva Vault to prepare dossiers, secure registrations, and ensure compliant labeling and claims aligned with commercial plans.
Regulatory Strategy & Risk Mitigation: Develop robust regulatory strategies (e.g., RSD) and conduct gap analyses to identify risks early; proactively manage the impact of regulatory changes and propose solutions to ensure products are scientifically robust and legally compliant.
Cross-Functional Collaboration & Process Excellence: Act as a strategic partner to Marketing, Sales, Supply Chain, and QA teams, embedding regulatory requirements into business processes (e.g., Quality Agreements, TTS); maintain SOPs and compliance databases to drive operational efficiency.
Stakeholder Engagement & External Representation: Serve as the primary point of contact for Health Authorities and industry bodies, managing inspections, responding to queries, and building strong relationships to facilitate smooth approvals and negotiations.
Regulatory Intelligence & Safety Oversight: Monitor global and local regulatory landscapes (including e-commerce and sustainability trends), analyze impacts on the portfolio, and establish robust safety review processes to ensure product integrity and compliance.
Team Leadership & Capability Building: Lead and mentor junior RA staff and cross-functional teams, delivering training programs to build organizational capability and fostering a culture of compliance and continuous improvement.
Specialized Compliance (E-commerce & Self-Care): Navigate the complex regulatory landscape for Cross-Border E-commerce and OTC/Self-Care initiatives, developing strategies to support market expansion, sustainable innovations, and accurate consumer communications.
Qualifications and skills
Education & Experience: Bachelor’s degree in a scientific or regulatory field (e.g., Pharmacy, Life Sciences) with 5–10 years of progressive experience in Regulatory Affairs, preferably within the consumer healthcare or pharmaceutical industry.
Technical Expertise: Proven ability to manage the full product lifecycle, including overseeing complex regulatory submissions (registrations, variations, renewals) via systems like Veeva Vault.
Strategic Acumen: Strong capability to develop and implement regulatory strategies and risk mitigation plans while interpreting complex global guidelines for diverse product portfolios.
Communication & Influence: Excellent written and verbal communication skills to effectively negotiate with health authorities, present to stakeholders, and deliver regulatory training to cross-functional teams.
Project Management: Demonstrated ability to lead cross-functional projects under tight deadlines, utilizing strong problem-solving and critical thinking skills to navigate complex regulatory landscapes.
Preferred
Strategic Input & Risk Management: Ability to provide expert recommendations to management, proactively assess regulatory risks, and develop mitigation strategies to address compliance gaps and ensure product safety.
Broad Regulatory Expertise: Extensive knowledge of global regulatory landscapes and diverse product categories (Rx/OTC, Medical Devices, Cosmetics, Food Supplements, etc.), with the adaptability to navigate evolving regulations and guidelines.
Stakeholder Communication & Influence: Proven effectiveness in building strong relationships and negotiating with regulatory agencies, industry associations, and internal cross-functional teams to facilitate smooth approvals.
Standards & Operational Know‑how: Familiarity with global standards and certifications (e.g., ISO, HACCP, Sustainability) and experience with manufacturing or R&D operations to support compliant product development.
Diversity, Equity and Inclusion
At Haleon we embrace our diverse workforce by creating an inclusive environment that celebrates our unique perspectives, generates curiosity to create unmatched understanding of each other, and promotes fair and equitable outcomes for everyone.
We’re striving to create a climate where we celebrate our diversity in all forms by treating each other with respect, listening to different viewpoints, supporting our communities, and creating a workplace where your authentic self belongs and thrives.
We believe in an agile working culture for all our roles. If flexibility is important to you, we encourage you to explore with our hiring team what the opportunities are.
