Are you looking for a new career opportunity?
Invenia Group has partnered with one of the world’s fastest-growing pharmaceutical companies, currently seeking a Senior Director for its Regulatory Affairs team.
Role responsibilities:
As Senior Director, Regulatory Affairs, you are responsible for leading regulatory strategy, development, and execution across the company’s biosimilar and generic product portfolios. You will serve as a senior leader and subject matter expert, guiding global regulatory submissions, interactions with health authorities, and ensuring compliance with applicable regulations. You will:
- Develop and lead regulatory strategies for biosimilar and generic products from early development through post-marketing
- Serve as a senior regulatory advisor to executive leadership, R&D, clinical, manufacturing, quality, and commercial teams
- Provide thought leadership on evolving regulatory frameworks for biosimilars and generics globally
- Oversee preparation and submission of high-quality regulatory filings
- Ensure timely approvals by proactively managing communications with FDA, EMA, and other global health authorities
- Lead regulatory due diligence for business development opportunities
- Ensure company-wide adherence to applicable regulations, guidelines, and internal SOPs
- Partner with Quality and Clinical functions to resolve regulatory issues and support inspections and audits
- Monitor and interpret regulatory changes, guiding internal teams on impact and implementation
- Build, mentor, and lead a high-performing regulatory team supporting biosimilar and generic programs
- Foster a culture of collaboration, accountability, and continuous improvement
- Represent Regulatory Affairs to senior leadership and external industry associations
What we are looking for:
We are seeking an individual with an Advanced degree in life sciences, pharmacy, or a related field (e.g., PharmD, PhD, MS, or equivalent). You should have 12-15+ years of progressive regulatory affairs experience in the pharmaceutical/biotech industry, with significant leadership responsibility and a proven track record of successful regulatory submissions and approvals in both biosimilars and generics.
Knowledge, skills, and abilities:
- Deep knowledge of global regulatory requirements for biosimilar and generic drug development
- Strong leadership, people management, and cross-functional collaboration skills
- Excellent communication, negotiation, and problem-solving abilities
- Strategic and forward-thinking regulatory leadership
- Ability to balance scientific, legal, and commercial considerations in regulatory decision-making
- High level of integrity, adaptability, and resilience in a dynamic environment
- Strong stakeholder management and executive presence
Sound interesting? This is a fantastic opportunity to join a company that recognises that developing the skills and capabilities of employees is essential to achieving organisational goals. Apply today to find out more.
