Katalyst CRO
Regulatory Affairs Consultant
Join Katalyst CRO as a Regulatory Affairs Consultant.
Responsibilities
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.
Requirements
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.
Seniority Level
Mid‑Senior level
Employment Type
Contract
Job Function
Legal
Industries
Pharmaceutical Manufacturing
Referrals increase your chances of interviewing at Katalyst CRO by 2x.
Get notified about new Regulatory Affairs Consultant jobs in
San Francisco, CA .
#J-18808-Ljbffr
Responsibilities
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.
Requirements
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.
Seniority Level
Mid‑Senior level
Employment Type
Contract
Job Function
Legal
Industries
Pharmaceutical Manufacturing
Referrals increase your chances of interviewing at Katalyst CRO by 2x.
Get notified about new Regulatory Affairs Consultant jobs in
San Francisco, CA .
#J-18808-Ljbffr