Regulatory Affairs Manager – Consumer Health

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.

Key responsibilities

• Lead end‑to‑end regulatory processes for new product launches and lifecycle maintenance, using Veeva Vault to prepare dossiers and secure registrations.
• Develop robust regulatory strategies, conduct gap analyses, and proactively manage the impact of regulatory changes.
• Act as a strategic partner to Marketing, Sales, Supply Chain, and QA, embedding regulatory requirements into business processes and maintaining SOPs.
• Serve as the primary contact for health authorities and industry bodies, managing inspections and building strong relationships.
• Monitor global regulatory landscapes, including e‑commerce and sustainability trends, and establish safety review processes.
• Lead and mentor junior RA staff, delivering training and fostering a culture of compliance.
• Navigate regulatory requirements for cross‑border e‑commerce and OTC/self‑care initiatives.

Required profile

• Bachelor’s degree in a scientific or regulatory field with 5–10 years of progressive Regulatory Affairs experience, preferably in consumer healthcare or pharmaceuticals.
• Proven ability to manage full product lifecycles and complex regulatory submissions via systems like Veeva Vault.
• Strong capability to develop and implement regulatory strategies and risk‑mitigation plans.
• Excellent written and verbal communication skills for negotiating with health authorities and presenting to stakeholders.
• Demonstrated project‑management skills to lead cross‑functional projects under tight deadlines.

Required skills

• Veeva Vault
• Regulatory submission management
• Risk analysis and mitigation
• Global regulatory guidelines knowledge
• ISO/HACCP compliance
• Sustainability regulations awareness