Senior Manager, Regulatory Affairs - Biologics / Remote EU
5 days left
- Experience Level
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.
- 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 work knows are in place and maintained, actively monitornprogress and ?nd 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
Permanent / full-time
Fully remote anywhere in Europe (any travel will be expensed by the client)
- If you would like to discuss this vacancy further or to discuss your career options in confidence, please contact Sam Chapple on +44 (0) 203 868 8607 or e-mail on firstname.lastname@example.org
- If this role is not suitable for you, please let us know if you can refer anyone – any recommendations are much appreciated! Planet Pharma offers a competitive referral scheme so you will be rewarded for your help!
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.
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