Katalyst CRO · 3 months ago
Regulatory Affairs Consultant.
San Francisco, CA
Contract
Onsite
Senior Level
6+ years expKatalyst CRO is seeking a Regulatory Affairs Consultant to enhance their regulatory function. The role involves collaborating with various stakeholders, leading regulatory activities, and ensuring compliance with regulations for clinical drug development.
AnalyticsBiopharmaData ManagementHuman ResourcesQuality Assurance
Responsibilities
We're looking for a Regulatory Affairs Consultant to join us and help drive and support our growing regulatory function
You will work collaboratively with other functional leaders across the organization, as well as external stakeholders
Our ideal candidate will have experience leading the regulatory function in different therapeutics areas and includes both tactical and strategic responsibilities
Work with the team to compile submissions of original IND and responses to all regulatory authority queries
Plan, oversee and participate in all regulatory activities, including regulatory 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 timely advance therapeutics to meet key development milestones including positioning for successful pivotal trials and registration
Qualification
Required
6+ years of industry experience in running global clinical regulatory operations and related activities in addition to successful track record as a regulatory consultant required
Excellent working knowledge of regulatory regulations, guidelines, and all phases of clinical drug development
Experience with Type D meetings and responses needed
Ability to lead and advise under pressure, respond to complex operational challenges with innovative solutions supported by appropriate tactics
Ability to occasionally work onsite from our San Diego offices
Company
Katalyst CRO
Katalyst CRO | Advancing Healthcare & Life Sciences with Expert Research & Regulatory Solutions Katalyst Healthcare & Life Sciences (Katalyst CRO) is a Global Contract Research and Knowledge Process Outsourcing Organization (CRO) dedicated to driving innovation in research, regulatory compliance, and quality excellence for pharmaceutical, biotechnology, and medical device companies worldwide.
51-200 employees
H1B Sponsorship
Katalyst CRO has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (37)
2024 (14)
2023 (24)
2022 (52)
2021 (54)
2020 (39)
Funding
Current Stage
Growth StageLeadership Team
John Patil
Recruiter, Pharma/CRO Staffing Division
Recent News
2024-04-07
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