Katalyst CRO

Regulatory Affairs Consultant.

Katalyst CRO, WorkFromHome

Join Katalyst CRO as a Regulatory Affairs Consultant.

Help drive and support our growing regulatory function.
Collaborate with functional leaders across the organization and external stakeholders.
Lead the regulatory function across therapeutic areas, handling both tactical and strategic responsibilities.
Compile submissions of original INDs and respond to all regulatory authority queries.
Plan, oversee, and participate in all regulatory activities, including submissions (INDs, NDAs, MAAs, CTAs, etc.), internal preparation, and agency meetings.
Serve as a company contact with the FDA and other regulatory authorities.
Ensure all external data complies with required specifications, standards, protocols, SOPs, and overall clinical objectives.
Enable creative solutions to regulatory challenges to advance therapeutics timely and meet key development milestones, including positioning for successful pivotal trials and registration.

6+ years of industry experience in running global clinical regulatory operations and a successful track record as a regulatory consultant.
Excellent working knowledge of regulatory regulations, guidelines, and all phases of clinical drug development.
Experience with Type D meetings and responses.
Ability to lead and advise under pressure, responding to complex operational challenges with innovative solutions.
Ability to work onsite occasionally from our San Diego offices.

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