Regulatory Affairs

Fractional Regulatory Affairs Vice President Consultant

about

The Partner
We Worked With

Our partner is a pioneering biotechnology company advancing mRNA science to create a new generation of transformative medicines. With a broad pipeline across infectious diseases, oncology, rare diseases, and autoimmune conditions, the organization leverages its mRNA platform to rapidly develop and deliver innovative therapies worldwide.

the role

Critical Objectives

This critical hire provided strategic leadership in regulatory affairs, overseeing global regulatory strategy, submissions, and compliance for key development programs. Collaborated with cross-functional teams to navigate complex regulatory environments, ensuring successful approval and market access for therapeutics. Advised on regulatory pathways, risk mitigation, and the preparation of high-quality submissions to health authorities.

key metrics

Proven, measurable
results

STAT. 1
3

days until hired candidate presented

STAT. 2
4

candidates presented

STAT. 3
20

days until search completed

Record of Success

Related case studies

Record of Success

Case studies