Regulatory Affairs Manager (CMC)
Based in Cork, our client is a global pharmaceutical company focused on developing first-in-class and best-in-class therapeutics that provide meaningful advances to patients who live with serious and life-threatening rare genetic diseases.
They require a Regulatory Affairs Manager with a background in the Biopharma industry and 4+ years Regulatory affairs CMC experience, to join them, initially on a 12- month contract.
The Regulatory Affairs CMC Manger works with the Regulatory Affairs Associate Director to support operations conducted. This role works closely with cross functional teams to ensure that the relevant product and regulatory expectations are met.
This role is remote for 1-4 days weekly with 1 day onsite weekly expected.
Job Reference: BBBH 21783
What will a Regulatory Affairs Manager do?
· Represent regulatory CMC at relevant site meetings and provide timely and accurate feedback to support site initiatives.
· Timely compilation and management of all necessary documentation for regulatory submissions. Ensure submissions are high quality; the content and format of regulatory submissions comply with application regulations and guidelines governing the development, licensure and marketing of drugs and/or biologics.
· Liaise with U.S. and Shanbally teams to prepare GMP documentation to support global submissions for product registrations and/or renewals.
· Participate in cross-functional project teams as a regulatory CMC representative for project specific discussions.
· Ensure consistent communication within the department and with other functional areas.
· Proactively identifying issues and suggesting appropriate strategies to mitigate risks.
- Assist in the preparation for interactions with global regulatory authorities
What does the Ideal Candidate look like?
- 4+ years Regulatory affairs CMC experience
- Site and global regulatory CMC experience
- Software/tools: Veeva vault ( a cloud enterprise content management platform and suite of applications specifically built for life sciences.)
- Biopharma industry background
- 28 days annual leave (pro-rata) plus paid bank holidays. Competitive Salary.
- Flexibility for working from home.
- State of the art modern office.
- Work Laptop, phone (most roles) and latest tools and technologies.
- Expanding workforce with options for permanent positions and career progress ion for top performers.
- The experience of working with a company that will make your CV stand out from the crowd.
Still interested in this opportunity?
Submit your CV (in a Microsoft Word format) today!
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