Regulatory Consultant (19-00193) – MA – Cambridge

Lead development of regulatory strategies for all projects in the portfolio (both small
molecule and biologics programs) assuring regulatory guidance is provided to teams from the time of Development Candidate (DC), through FIH and POC studies. The EDRD will lead all early regulatory submissions including preparation of INDs/CTAs for FIH and POC studies. The EDRD will also partner with DU RA representatives in supporting a smooth transition of programs into the Development portfolio, aligning transitions with the formation of a Development Global Project Team. The EDRD will lead the regulatory activities in planning for early Health Authority (HA) interactions for all ED
programs including pre-IND meetings, early scientific advice meetings (pre and post IND/CTA filing).
The EDRD will provide global regulatory leadership identifying and evaluate issues, regulatory risks/gaps for projects and provide a regulatory strategy towards registration and provide this in Development Plans, in alignment with DU RA representatives.

excellent collaboration, communication and leadership skills. Ability to think outside the box. Ability to work closely with less experienced team members, mentoring and negotiating.
Source: Job Diva – Job Listing

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