Regulatory Strategist - Leading Bio-Pharmaceutical - Hybrid in Hillingdon

!*Regulatory Strategist - Leading Bio-Pharmaceutical - Hybrid in Hillingdon*!

Location: Hybrid in Chester

FTE: Full time

Start date: ASAP

Planet Pharma are working with a global biopharmaceutical company focused on discovering, developing, and delivering innovative medicines for serious diseases.

They prioritise treatments in oncology, immunology, cardiovascular diseases, and hematology, aiming to improve patient outcomes and address unmet medical needs. Known for their research-driven approach, they invest heavily in R&D to advance therapies in areas such as cancer immunotherapy, autoimmune diseases, and cardiovascular health.

Role Overview:

The European Regulatory Procedural Strategist (ERPS) team is responsible for leading and managing the procedural and operational aspects of European regulatory filings within the European Centralised Procedure, collaborating closely with the European Regulatory Liaison group and relevant regional and global teams.

Key Responsibilities:

• Manage the procedural and operational aspects, providing support for the preparation and filing of new Marketing Authorisation Applications as well as Life Cycle Management under the European Centralised Procedures.
• Plan, track, and coordinate activities related to regulatory submissions within the EU.
• Communicate updates on regulatory submission timelines, statuses, and changes, keeping all stakeholders informed of both minor and significant product updates.
• Provide logistical support for meetings with EMA, national Health Authorities, and other related engagements.
• Collaborate with the European Regulatory Liaison (ERL) to develop European strategies through research, competitive analysis, and participation in multidisciplinary project teams, including business stakeholders as needed.
• Draft regulatory documentation in Module 1 and lead reviews of quality variations.
• Serve as a backup to the ERL for team meetings and interactions with Health Authorities.
• Lead reviews of new regulations and guidelines, author/review internal procedures, and represent the team in interdepartmental and global taskforces.
• Develop, maintain, and monitor planning processes to ensure efficient tracking.
• Stay updated on regulatory requirements, changes in the industry, competitive activities, and shifts in governmental regulations to enhance the effectiveness of the function.

Requirements:

• European Centralised Procedure experience is a must. Minimum 2 years experience.
• Experience with Marketing Authorisation Applications, Life Cycle Management and PIP (Paediatric Investigation Plan)
• Must have experience with type 1 and 2 variations

If you would like to discuss this vacancy further or to discuss your career options in confidence, please email me on: akilby@planet-pharma.co.uk

If this role isn’t 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 recognized 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