ProClinical is advertising a vacancy for a Regulatory Senior Director CMC position with a leading global pharmaceutical company that focuses on developing first-in-class therapeutics that provide meaningful advances to patients who live with rare genetic diseases. Based in London, this is an exciting opportunity to work with a company that aims to make meaningful impacts on patients' lives.
The Regulatory Affairs Senior Director will lead the company's R&D group, which is responsible for everything from research and discovery to post-market clinical development. This will involve all bench, clinical research, and the associated groups that support those endeavours.
Job Responsibilities:
- Defining EU CMC Regulatory strategy for commercial and development programs and ensuring that work is carried out to company priorities and timelines.
- Proactively managing EU CMC aspects for global commercial programs, including overseeing preparations and submissions of marketing and clinical trial applications.
- Representing the company's EU Reg CMC Department at Regulatory Authority meetings.
- Managing and developing direct reports in the EU Reg CMC team.
- Researching and interpreting EU and Swiss CMC regulations to provide regulatory guidance to Quality, Manufacturing, Process Development, and other functional groups.
- Developing excellent relationships with internal functional groups, contract manufacturing organisations, and corporate partners.
- Representing the EU Regulatory Affairs CMC function on assigned cross-functional project teams to enhance and develop business processes.
- Managing interactions with EMA and Swiss Medic for assigned project to ensure acceptance, rapid review and approval of marketing applications, supplements/variations, clinical trial applications, and other submissions which present CMC information.
Skills and Requirements:
- A B.Sc. or higher degree in life sciences, such as biology, chemistry, molecular biology, or similar.
- At least 10 years in Regulatory Affairs in a global pharmaceutical and/or Biotechnology Company, with expertise in commercial biologics/large molecules and a deep understanding of lifecycle as well as Phase I-III.
- A thorough understanding of relevant drug development regulations and guidelines.
- Prior success with communication and influencing global teams on matters of EU Reg CMC strategy for commercial and development programs.
- Prior success filing marketing applications, supplements, and variations for biologic products within timelines; global submission experience desired.
- A thorough understanding of complex biological manufacturing processes and experience in assessing post-approval changes is required.
- Experience with small molecules is beneficial.
- Capable of travelling for 30% of the role.
- Demonstrable multitasking, project management, and execution skills.
- Good interpersonal skills, including communication, presentation, persuasion, and influence.
- Good organisational skills, including efficiency, punctuality, and collaboration in a team environment.
- Proficiency with computer skills, such as MS Office.
To Apply:
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please contact Roberto Esposito at +44 203 761 5702 or upload your CV on our website - www.proclinical.com.
A full job description is available on request.
ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
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