Regulatory Affairs CMC Senior Manager - Fully remote / permanent

SUMMARY

Our growing Regulatory Affairs team will give you the opportunity to have a true impact on the success of your projects beyond what is possible in established large biotech companies. You will actively collaborate with cross-functional development teams and leadership representatives regarding strategical and operational topics from early development up to product registration and launch.

RESPONSIBILITIES

• Provide regulatory guidance to projects teams on all aspects of technical development and production.
• Ensure that CMC sections for IMPDs/INDs, MAAs/BLAs and briefing books are written on time and with high quality, in close collaboration with other members of the regulatory team.
• Respond to CMC-related questions from health authorities to ensure regulatory approvals.
• Prepare the technical development team and take part in CMC-related health authority meetings, identify risks and develop response strategies.
• Ensure document review and approval work rows are in place and maintained, actively monitor progress and solutions in case of issues.
• Escalate CMC issues impacting submission timelines to the leadership team.
• File and archive regulatory documentation, including correct formatting according to global requirements.
• Coach/mentor junior regulatory affairs team members.
• Monitor changes in the regulatory landscape impacting quality aspects of biosimilar development.

QUALIFICATIONS

• MSc/PhD in biotechnology, biochemistry, biology or equivalent.
• 3-5 years (Regulatory CMC Manager) or > 7 years (Regulatory CMC Senior Manager) of industry experience in regulatory CMC activities with focus on biologics/monoclonal antibodies, ideally biosimilars.
• Track record in the preparation of the CMC/quality sections of CTAs, INDs and ideally MAAs/BLAs.
• Practical experience in CMC development, including aspects such as cell line development, process development, analytical methods, comparability studies and similarity assessments.
• Knowledge of relevant legislation and international guidelines with focus on EU and US.
• Excellent planning, communication, documentation and organizational skills with hands-on mentality.
• Ability to work successfully in a matrix organisation in cross-functional teams.
• Fluent English (written and oral), Polish of advantage.

 DURATION

Permanent / full-time

SALARY

Competitive salary

LOCATION

Fully remote anywhere in Europe (any travel will be expensed by the client)

ABOUT PLANET PHARMA

Planet Pharma is an American parented Employment Business/Agency that provides global staffing services with its head-quarters in Chicago and our EMEA regional office located in Central London. We have invested significantly in creating a robust international platform that enables us to work compliantly in 30+ countries with a current network of 2500+ active contractors globally as well as a very strong permanent / direct hire recruitment offering.

Our specialist knowledge and close relationships with our clients and the wider industry really makes us unique in our field. Just recently we were recognised by FORBES as the 17th best professional staffing firm, and have won multiple awards from industry accredited bodies for our commitment to excellence and service delivery. We have extensive functional expertise including: Regulatory Affairs, Pharmacovigilance, QA, QC, Submissions experts, Clinical development, Quality, Biostatistics, and Medical Affairs / Writing.

We are an equal opportunities Recruitment Business and Agency. We welcome applications from all suitably qualified candidates regardless of their race, sex, disability, religion/belief, sexual orientation or age.

www.planet-pharma.com