Job Description
Senior Regulatory Affairs Manager
Blackfield Associates are supporting a fast moving pharmaceutical company who, due to consistent growth are looking for an experienced Senior Regulatory Affairs Manager, who will lead interactions with the health authorities and manage new MAA/ new drug applications.
We're looking for an expert in DCP cycles, able author dossiers.
As Senior Regulatory Affairs Manager, you will:
* Review and assess adequacy of the non‐clinical and clinical data package for regulatory submission based on available scientific guidance, precedence, previous experience and any scientific communication with any health authority if available specific to the development program. Seek clarification from developer to make informed decision, work cross functionally to assess risks/mitigation, assess need that may benefit from any further regulatory HA interaction.
* Actively be involved in due diligence of the dossier covering modules 1 to 5 and will be responsible to assess adequacy of these sections and any responses to questions during review. The role will work collaboratively with internal stakeholders and external stakeholders to finalise sections of MAA.
* Contribute actively in any future development plans by working closely with new products team to define regulatory strategy required to support MAA.
* Support post‐approval regulatory activities to ensure timely preparation of various documents and studies required by EMA for an EU orphan registered product. Working closely with internal teams and other CRO’s supporting these efforts.
* Support the coordination and registration of assigned generic products in coordination with the internal teams.
To be considered for the role of Senior Regulatory Affairs Manager, you will:
* Minimum of 7 years experience in Regulatory, working hands on with new/ initial indications and new MAA
* Proven experience with EU regulatory requirements, particularly with Decentralised Procedures
* Clear experience gained from managing product lifecycle, including Marketing Authorisation submissions, (DCPs, MRPs), set up and implement post‐approval line‐extension and variation strategies, maintenance activities
* The right candidate will be a technical, autonomous individual with ambition and comfortable with a fast-paced regulatory environment
This is permanent, full time position based in Slough. This role is an individual contributor, working in a matrix environment with rapid expansion. Hybrid working.
All candidates must have the valid right to work, this opportunity is unable to sponsor.