Director of Regulatory Affairs - Munich, Deutschland - Cpl Life Sciences

Beschreibung

Reference Number:

JO
Director of Regulatory Affairs -Infectious Disease


Rate:
Negotiable


Job Type:
Permanent


Location:
Munich


Job Title:
Director, Regulatory Affairs - Infectious Diseases


Location:
Munich
, Germany - Hybrid working


Salary:
Attractive salary plus benefits package (stock options, car allowance, bonus)

Working for one of the industry's most innovative biotechnology companies, this is a fantastic opportunity to provide expert regulatory knowledge to an early-stage infectious disease development program, with a focus on the EU market.

This role will be responsible for leading the EU Regulatory Team across multiple geographies, providing support, mentorship, and advice in a challenging regulatory environment.

You will have a sound understanding of the infectious disease space, be able to devise strategies in line with business requirements globally, and be able to influence at a high level internally and externally.

Responsibilities:

• Lead, manage and develop EU regulatory team members by serving as a resource for EU knowledge for the global regulatory and development teams and for the reporting EU regulatory team.
• Build the representation of EU regulatory function to EMA and EU National Agencies, as well as Alliance partners as required.
• Responsible for planning and ultimately leading MAA related processes and strategy to ensure timely product approvals with competitively differentiated labelling.
• As needed, support activity with Business Partners to ensure the EU regulatory strategy meets business objective.
• Monitor emerging legislation and guidance in the EU and contribute to ensuring companylevel awareness and compliance (where appropriate).
• Provide support to department liaisons with their project specific communications and issues, including Agency meetings, responses to CTA challenges and CRO oversight as required.
• Ensure emerging issues are flagged to EU regulatory leadership in a timely manner.

Job Requirements

• Advanced degree in a scientific discipline.
• 10+ years regulatory experience with a focus on supporting products through clinical development.
• Experience of managing and developing staff members desirable.
• Proven track record of supporting EU Clinical Trial Applications through approval and study start up.
• Experience in dealings with the EMA (scientific advice, orphan designation, PIPs).
• Experience of providing EU regulatory strategy for infectious diseases is desirable.
• Experience of monoclonal antibodies is desirable.
• Experience of bringing a product through EU approval is a distinct advantage.
• Ability to negotiate and concisely express clear positions to stakeholders at all levels.
• Experience of directly working with national regulatory agencies and leading agency meetings face to face.
• Excellent written and verbal communication skills.

This is a great opportunity for a science-minded individual to work at the heart of innovation on a developing infectious disease portfolio.

You will take lead and work with senior board members across the globe to define regulatory / business strategy.