Regulatory Affairs Manager / Senior Manager

Our growing regulatory 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.

• Provide regulatory guidance to projects teams on aspects of clinical and non-clinical development.
• Drive preparation of CTAs/INDs and MAAs/BLAs according to project timelines. Ensure high quality of regulatory documentation in close collaboration with members of the regulatory team and external consultants. Coordinate handover of CTAs for local submissions. Maintain IND including direct interactions with FDA program managers.
• Liaise with regulatory counterparts at CROs to align on requirements for clinical studies.
• Ensure that questions from health authorities are answered on time.
• Lead the preparation and take part in health authority meetings, identify risks and develop response strategies.
• Ensure document review and approval workflows are in place and maintained, actively monitor progress and find solutions in case of issues.
• File and archive regulatory documentation, assure correct formatting according to global requirements.
• Monitor changes in regulatory guidelines, activities of competitor programs and updates in the labelling of originator products based on data base searches. Identify regulatory trends impacting biosimilar development.
• Coach/mentor junior regulatory affairs team members.

• MSc/PhD in pharmaceutical sciences, biotechnology, biology, biochemistry or equivalent.
• 3-5 years (Regulatory Affairs Manager) or > 7 years (Regulatory Affairs Senior Manager) of industry experience in regulatory affairs, ideally with focus on biosimilars.
• Track record in the preparation of CTAs and INDs (and ideally MAAs/BLAs). Knowledge in procedural aspects of regulatory submissions for EMA and FDA.
• Experience working together with CROs and external consultants in the review of clinical study protocols and reports, Investigator Brochures and Informed Consent Forms.
• Practical experience in eCTD publishing and compilation of dossiers.
• Excellent planning, communication, documentation and organizational skills with hands-on mentality
• Ability to work successfully in a matrix organisation in cross-functional teams
• Knowledge of relevant legislation and international guidelines with focus on EU and US
• Fluent English (written and oral), Polish of advantage