Regulatory Affairs Manager

Position Summary

We are seeking a strategic and experienced Regulatory Affairs Manager to lead the development and execution of global regulatory strategies for our portfolios. This role is critical for ensuring timely market access and maintaining compliance throughout the product lifecycle. We are open to candidates with a strong background in either the medical device or pharmaceutical industry, recognizing the unique and transferable skills each brings.

Key Responsibilities

• Regulatory Strategy & Execution:

  • Define and implement global regulatory strategies for new and existing products to ensure rapid, predictable, and cost-effective approvals.

  • Lead the preparation, compilation, and submission of high-quality regulatory dossiers.

  • Manage the entire lifecycle of product approvals, including post-market surveillance, renewals, and variations.

• Cross-Functional Leadership & Collaboration:

  • Act as the central regulatory advisor to cross-functional teams, including R&D, Clinical Affairs, Quality Assurance, and Marketing.

  • Provide expert regulatory input into product development, design changes, clinical trial strategies, and risk management processes.

  • Lead and manage interactions with global regulatory authorities and Notified Bodies, including preparing for and managing meetings and audits.

• Regulatory Intelligence & Compliance:

  • Proactively monitor and interpret changing global regulations to assess impact and ensure ongoing compliance .

  • Develop and maintain internal procedures and Standard Operating Procedures (SOPs) to ensure consistent regulatory practices .

  • Guide the company on emerging trends, such as digitalization and AI in regulatory processes .

Qualifications & Experience

Education:

• Bachelor’s degree in a scientific, engineering, or life sciences discipline is preferred.

• An advanced degree (MSc, PhD, PharmD) or a Regulatory Affairs Certification (RAC) is highly preferred.

Experience:

• Minimum of 4-7 years of experience in a Regulatory Affairs role within the healthcare industry.

• Proven track record of leading submissions.

• Strong experience in managing agency interactions.

Skills & Competencies:

• Strong project management skills with the ability to manage multiple complex projects simultaneously.

• Excellent written and verbal communication skills, with the ability to articulate complex regulatory issues clearly.

• Strong negotiation, influencing, and stakeholder management abilities.

• Precise, structured, and pragmatic approach to problem-solving.

Why Join Us?

• A collaborative and supportive work environment that values professional growth.

• Competitive salary and comprehensive benefits package.

• The chance to shape the regulatory strategy in a dynamic and evolving field.