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International Senior Manager CMC

Barrington James Board and Executive Partners are collaborating with a global pharmaceutical company who are committed to transforming lives through innovative medicines. By developing innovative pharmaceuticals across a variety of therapeutic areas, the company are striving to generate value for the business and the wider community.

We’re seeking a talented Global Senior Regulatory Affairs CMC Manager to lead regulatory activities for a pivotal rare disease product within the portfolio. This is your chance to be part of a dedicated team that strives to make a difference in the lives of patients worldwide.

Responsibilities

As the Global Senior Regulatory Affairs CMC Manager, you will play a key role in driving the regulatory strategy and activities related to Chemistry, Manufacturing, and Controls (CMC) for a high-impact rare disease product. You will collaborate with cross-functional teams to ensure compliance, expedited approvals, and successful market access across diverse regions. If you’re ready to make a significant impact in the field of rare diseases, please read further:

• Develop and execute global regulatory CMC strategies in alignment with overall product development and registration plans.
• Provide strategic guidance on CMC aspects of regulatory submissions, including INDs, NDAs, and BLAs, ensuring timely approvals.
• Collaborate with internal teams and external partners to ensure adherence to global regulatory guidelines and requirements.
• Lead interactions with health authorities (FDA, EMA, etc.) for CMC-related matters, including pre-submission meetings and response to inquiries.
• Proactively identify and mitigate potential regulatory risks or roadblocks, developing contingency plans as needed.
• Drive continuous improvement initiatives related to regulatory processes, standards, and practices.

Qualifications

• Advanced degree in a scientific discipline (Ph.D., M.Sc., Pharm.D.) preferred.
• >5 years of experience in Regulatory Affairs CMC within the pharmaceutical industry.
• Proven track record of successful interactions with health authorities.
• Strong understanding of global regulatory guidelines and requirements for CMC aspects.
• Exceptional communication skills, with the ability to collaborate effectively across functions and regions.

Benefits

• Competitive Base Salary
• Enhanced Bonus Scheme
• 25+ days holiday
• Private Health Insurance
• Life Insurance
• Enhanced Pension Scheme
• Travel Allowances
• Clear Development Opportunities
• Flexible Working

Following your application Francesca Hallworth, a specialist Pharmaceutical Recruiter will discuss the opportunity with you in detail. She will be more than happy to answer any questions relating to the industry and the potential for your career growth. The conversation can also progress further to discussing other opportunities, which are also available right now or will be imminently becoming available.

This position has been highly popular, and it is likely that it will close prematurely. We recommend applying as soon as possible to avoid disappointment. Please click ‘apply’ or contact Francesca Hallworth for any further information.