Katalyst CRO ยท 5 days ago
Sr. Regulatory Affairs Manager
Boulder, CO
Full-time
Onsite
Senior Level
5+ years expKatalyst CRO is focused on regulatory affairs within the pharmaceutical and biotech industry, and they are seeking a Senior Regulatory Affairs Manager to support the Senior Director in developing and executing regional regulatory strategies. The role involves collaborating with cross-functional teams, preparing regulatory documents, and managing relationships with regulatory authorities to ensure compliance and alignment with company objectives.
AnalyticsBiopharmaData ManagementHuman ResourcesQuality Assurance
Responsibilities
Support the Senior Director in developing and executing regional regulatory strategies for QOL initiatives within specific regions
Contribute to providing strategic oversight and leadership to the regulatory team, ensuring alignment with company objectives and regional regulatory requirements
Participate in the preparation and submission of regulatory documents related to QOL initiatives to regulatory authorities
Collaborate with cross-functional teams to integrate QOL considerations into product development, manufacturing, and commercialization processes
Assist in fostering relationships with regional regulatory authorities to facilitate communication, negotiations, and interactions related to QOL initiatives
Stay informed about regulatory developments, changes, and trends within specific regions, and provide insights to the Senior Director and Associate Director
Contribute to managing regulatory risks and opportunities related to QOL initiatives and assist in developing mitigation strategies as needed
Provide regulatory guidance and support for post-marketing activities related to QOL initiatives, Including variations, renewals, labeling updates, and compliance initiatives
Collaborate with the regulatory team to represent the company's interests in industry forums, working groups, and regulatory meetings related to QOL initiatives
Support coordination with global regulatory counterparts to ensure alignment of regional regulatory strategies and submissions with global development plans and corporate objectives
Assist in preparing regulatory updates, progress reports, and strategic recommendations for senior and/or executive leadership and regulatory governance committees
Assists in preparing and organizing all necessary documentation required for regulatory inspections and inspection readiness initiatives ensuring completeness, accuracy, and accessibility of records related to QOL initiatives
Participates in facilitating communication, providing requested documentation, and addressing any questions or concerns raised by the inspection readiness team in a timely and professional manner
Qualification
Required
Bachelor's degree in a scientific discipline such as life sciences, pharmacy, bioscience
Must have branded product reg affairs experience
Demonstrated ability to work effectively in a cross-functional team environment
Strong knowledge of regional regulatory requirements and guidelines, including FDA regulations and ICH guidelines
Excellent communication and interpersonal skills
Ability to assist in developing and executing regulatory strategies tailored to specific regions
Strong organizational skills with attention to detail
Ability to collaborate effectively with cross-functional teams
Knowledge of regulatory submissions and documentation processes
Awareness of regulatory developments and trends within specific regions
Strong analytical and problem-solving skills
Ability to work independently and prioritize tasks effectively
Ability and willingness to travel approximately 10% of the year both domestically and internationally
Preferred
advanced degree preferred
5+ years of experience in regulatory affairs within the pharmaceutical or biotech industry, with a focus on quality-of-life products preferred
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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