Senior Product Specialist, Regulatory Affairs (Maternity Cover - 12-Month FTC)

London, United Kingdom – Hybrid (3 days per week in-office – St James Park) At Theramex we are driven by a clear purpose of improving the lives of women around the world through innovative and accessible healthcare. As one of the fastest‑growing global specialists in Women’s 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. You’ll join a collaborative, high‑performing team that values expertise, encourages fresh thinking, and empowers people to lead with ownership.

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 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 Responsibilities

• Prepare and submit required regulatory packages for designated products/countries, including variations and lifecycle activities.
• Author, update and review key regulatory documents (CTD components, Product Information, etc.) to ensure compliance.
• Develop and implement 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 internal stakeholders (MS&T, Quality, Pharmacovigilance, Supply).
• Identify gaps in regulatory documentation and conduct necessary remediation.
• Communicate with external stakeholders, including regulatory agencies, CMOs and third‑party service providers.
• Create and maintain regulatory information management systems, databases, SOPs and working instructions.

Qualifications

• Extensive experience with practical European Regulatory Affairs, including MA lifecycle activities within DCP, MRP, and National procedures.
• Understanding of post‑authorisation variations impacting CMC, safety, and product information.
• Experience with renewals, PSURs/PSURAs, and other regulatory activities.
• Knowledge of CTD/eCTD documentation structure and lifecycle management.
• Familiarity with regulatory submissions across different markets and procedures, including the Centralised Procedure.
• Ability to author, edit, and manage product information and CMC documentation.
• Capability to support other RA activities such as PASS, PAMs and Centralised Procedure submissions.
• Strong interpersonal, problem‑solving, proactive and adaptable skills; ability to work across multiple projects with high standards.
• Excellent organisational, time‑management, written and verbal communication skills in English.
• Desirable degree in Pharmacy, Biology, Chemistry or related discipline.
• Desirable experience with distributor markets via third‑party contractors and in planning and project management.

Benefits & Perks

• Competitive reward package.
• 25 days holiday + 8 bank holidays.
• Private health insurance for employee and family members.
• Pension contribution: 10% company + 5% employee (auto‑enrolled from day one).
• Hybrid working.
• Cycle to Work scheme.
• Engaging employee experience with in‑office events and shared learning.