Director Regulatory Affairs Europe

Overview:

On behalf of our client, a pharma-biotech company developing innovative oncology medicines, we are seeking a Director of Regulatory Affairs.

Job Overview:

Your primary role is to craft and execute regulatory strategies for our designated program, ensuring alignment with business goals and close collaboration with internal stakeholders.

Your Responsibilities:

• Formulate regulatory strategies tailored for European markets, influencing clinical development plans and spearheading marketing authorization applications.
• Serve as the European regulatory team's spokesperson within the global regulatory team for assigned projects.
• Take charge of regulatory documentation including PIPs, ODAs, and briefing materials for engagements with European regulatory bodies.
• Conduct thorough submission analyses, pinpoint potential risks, and devise mitigation plans for successful submission acceptance and timely approvals.
• Oversee and ensure the quality of regulatory agency communications, submissions, and approvals, aiming for first-cycle approvals.
• Provide leadership and mentorship to team members.
• Stay abreast of evolving laws, regulations, and guidelines across European regulatory authorities.
• Represent Corporate's European regulatory function in industry consortiums as needed.
• Collaborate with other departments such as legal, compliance, QA, CMC, operations, and labeling groups to ensure compliance and business continuity.

Reporting: To the Senior Director – Team Lead Regulatory Affairs, Europe and New Markets.

Required Qualifications:

• A degree in a scientific discipline or equivalent.
• Minimum 15 years' experience in the biotech or pharmaceutical industry, with at least 10 years in a regulatory role.
• Experience working directly with EMA for EU regulatory procedures is a must.
• Comprehensive understanding of drug development processes, pharmaceutical industry dynamics, and healthcare landscapes, including global and EU regulatory requirements.
• Preferably recent experience with oncology products and familiarity with MAAs, ODD, and PIPs.
• Demonstrated ability to achieve objectives within cross-functional teams with professionalism.
• Fluency in English is preferred, and remote work may be possible.

Location: Europe, with Switzerland being preferred.

Supervisory Responsibilities: Yes

Computer Skills: Proficiency in Microsoft Office 365 suite software including Word, Excel, Outlook, and Adobe.

Contact :

Gilles COUTARD – HealthTech Executive Recruitment - ANTAL International – https://www.linkedin.com/in/gilles-coutard/ Haut du formulaire

Ref CJR-20240206-DRA-GC