Katalyst CRO ยท 1 day ago
Sr. Regulatory Affairs Manager
Baltimore, MD
Contract
Onsite
Senior Level
7+ years expKatalyst CRO is a clinical research organization seeking a Senior Regulatory Affairs Manager to provide regulatory strategy and development guidance for clinical trials. The role involves coordinating regulatory submissions, maintaining knowledge of regulations, and providing strategic regulatory input throughout the clinical development life cycle.
AnalyticsBiopharmaData ManagementHuman ResourcesQuality Assurance
Responsibilities
The Regulatory Manager (RM) provides regulatory strategy and development guidance for optimal conduct of clinical trials, regulatory agency meetings, orphan designations, pediatric planning, and accelerated procedures, ensuring timely preparation of well organized, quality regulatory submissions in compliance with applicable regulations
The RM coordinates and prepares regulatory documents for submission to Regulatory Authorities and / or Ethics Committees, as applicable
The RM maintains a current knowledge of regulations and guidance documents, providing analysis to project teams, as well as supporting and enhancing Precision for Medicines corporate Regulatory function
Provides regulatory guidance throughout the clinical development life cycle
Compile, coordinate and review applications to Regulatory Authorities including, but not limited to, CTA / IND, annual reports, routine amendments, scientific advice / regulatory authority meetings, orphan designations, paediatric planning, and marketing applications
Also provides strategic regulatory input as required
Develops and / or reviews documents intended for submission to the Regulatory Authorities and / or Ethics Committees to assure compliance with regulatory standards
Serve as representative of Global Regulatory Affairs at project team meetings with both external and internal customers
Works within a project team, and where necessary, leads project for the region or globally
Oversee and coordinate Regulatory Affairs Specialists to achieve submission targets for contracted programs
Maintenance of project plans, project trackers and regulatory intelligence tools as it pertains to assigned responsibilities and to keep Regulatory Leadership updated
Assist in development of Regulatory Affairs Specialists and other operational area staff, as required
Provide input, as required, into regulatory strategy and timeline development for new study opportunities Assists in establishing company standards to ensure the highest quality of submitted information
Participates in maintaining and executing on the corporate quality initiatives across business units within clinical solutions
Keeps abreast and continually expand knowledge of laws, regulations and guidelines governing drug development and approval
Provides ICH GCP guidance, advice and training to internal and external clients
Serve as representative of Global Regulatory Affairs at business development meetings
Ability to understand clinical and pre-clinical study results, to help in its interpretation for regulatory positions and strategy
Knowledge and expertise with relevant regulations and guidance supporting pharmaceutical development
Availability for domestic and international travel including overnight stays
Motivates other members of the project team to meet timelines and project goals
Flexible attitude with respect to work assignments, and new learning
Resolves project related problems and prioritize workload to meet deadlines with little support from management
Focuses on continuous improvement, including the ability to make proactive assessments on how to make processes more efficient and people more effective
Collects data of consistently high standard
Communicates effectively in the English language both verbally and in written form
Conducts formal presentations to a wide variety of audiences including colleagues, investigative staff, and clients with a high level of proficiency
Qualification
Required
Bachelor's degree, or equivalent experience, ideally in a scientific or healthcare discipline
7 years Regulatory experience required for the Senior Manager Regulatory level
Candidates must have regulatory affairs experience working for a Clinical Research Organisation and have experience leading Clinical Submissions
Informed knowledge of all aspects of the drug development process inclusive of regulatory milestones and specialized knowledge of regulatory activities for at least one major region (EU, US) including but not limited to submissions to Regulatory Authorities, including INDs / CTAs and amendments, Scientific Advice Procedures, and post-approval submissions
Knowledgeable of clinical trials methodology, including a working knowledge of protocols and indications being studied
Strong interpersonal skills and a proven ability to contribute to a team environment involving balancing the demands stemming from multifaceted research activities
Demonstrates an acceptable degree of professionalism, as evidenced by punctuality, ability to deliver on commitments, an understanding of the service culture and positive interactions with customers and teammates
Ability to manage multiple and varied tasks in a fast-moving environment, good record-keeping skills
Exhibits high self-motivation and can work and plan independently as well as in a team environment
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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