Reference Number: JO-2104-466524
Senior Manager Global Regulatory Affairs CMC
Job Type: Permanent
Location: Dublin City Centre
Role: Senior Manager Global Regulatory Affairs CMC Biologics
Location: Ireland (homeworking offered/remote options available)
Salary: Highly competitive + benefits
employment: full time, permanent
CPL Life Sciences are collaborating with a global biopharmaceutical company focused on human health. Our client is seeking an experienced CMC Regulatory professional to join their team based in Ireland. In this role, you will manage the regulatory activities associated with Chemistry, Manufacturing, and Controls for licensed and clinical biologic products. To be considered for this role, you will need at least 5 years of experience in a regulatory function, broad knowledge/experience of EU, FDA, and global regulations, and finally, experience with Biologic products.
Responsible for creating innovative regulatory strategy and assuring this regulatory strategy is aligned with Health Authority requirements from a global perspective
Manage the global manufacturing sites, integrate regulatory strategy with those sites, and communicate to senior management.
Generate collaborative working relationships with Global Regulatory Affairs (scopes: corporate, regional, national), Technical and Quality Groups within R&D and Industrial Affairs, External Alliance Partners, Project Direction/ Management, Regulatory Health Authorities
Oversee new applications for biologics through planning, preparation, submitting, reviewing support for product dossiers
Lead the license maintenance with annual reports (the US, Canadian NDC, and YBPR, license and renewals) and site renewals (ex. Japan Accreditation)
Coordinate the regulatory strategy development by ensuring the preparation and review of submissions, the technical review of site supporting documents (CoA, SMF, MBR, SOPs)
Evaluate Global Regulatory CMC strategies and risks to develop projects and/or marketed products.
Collaborate with the CMC teams to achieve implementation of appropriate regulatory strategies with regards to the financial impact and all identified risks
Specific Knowledge, Skills, and Experience
Eligible to work within the UK/EU
Bachelor or ideally masters scientific, healthcare, or life sciences degree, RAC certification is an asset
Communication, leadership, team spirit, organizational skills
IT skills: MS Word, Excel, PowerPoint, MS Project, and Track wise
Oral and written fluency in English
If you would like to apply for this position, please contact Amani via amani.yousef@CPL.com. If you are not currently looking but know someone who would be good for this role then get in touch. We offer a referral scheme at Regulatory Professionals where in which a successful recommendation will earn you 250 worth of vouchers *terms and conditions apply*