Snr Director Regulatory - Contract

In collaboration with a well funded fast paced BioTech, BioTalent are looking to connect a seasoned Regulatory Industry professional to fulfil EU and UK requirements in alignment with the Global Team.

This role will offer you

• 3-6 month rolling contract
• Ability to work part time
• Hourly pay rate
• Remote working

You will be responsible for

• Being the face/lead of EU Regulatory Affairs, strategy, process and execution.
• Approvals, Labelling, MAA, Dossier, Submissions
• Assessment of risks and mitigations

You will bring the following

• Long standing Regulatory industry experience with availability for 0.8-1.0 FTE
• Crossfunctional team working ability, mental agility, confidence and successful track record
• Experience developing and taking MAA through to completion from a Biotech lead product perspective (inclusive of IMPDs, INDs and NDAs)