Match score not available

CMC Regulatory Manager, Biologics

Remote:

Full Remote

Contract:

Full time

Experience:

Mid-level (2-5 years)

Work from:

New Jersey (USA), United States

Offer summary

Qualifications:

Proven experience in CMC regulatory affairs, Knowledge of GMP submission requirements, Strong understanding of global regulations, Experience in biologic product strategy development, Ability to lead complex regulatory discussions.

Key responsabilities:

Support client in regulatory submissions
Ensure CMC compliance with global regulations
Lead execution of global product regulatory strategies
Develop and review CMC submission components
Communicate developments and manage risks effectively

Katalyst HealthCares & Life Sciences Pharmaceuticals SME https://www.katalysthls.com/

51 - 200 Employees

See more Katalyst HealthCares & Life Sciences offers

Job description

Responsibilities:

This project is staff support to a large client, filling in as a member for their team in-leu of their own.
This program is intended to support client in their requested requirement for regulatory submissions that may have impact on registrations of Biologic formulations.
Support through a number of regulatory functions specific to post-approval, lifecycle management capacities for Biologics which includes –
Proven record of successful biologic product strategy based on science, known industry trends and articulation of approaches through RA risk management techniques
Knowledge of scientific, technical, & regulatory issues to drive and execute on global product strategy development and commercial lifecycle.
Participate in global teams that require experienced interpretation of applicable EMA/FDA/ICH/WHO/Global regulations to ensure CMC compliance.
Acts as CMC regulatory expert for developing regulatory advise on complex topics and sharing with influence to global project teams/task forces.
Ensure that project team colleagues, line management, and partners are informed of developments, risks and opportunities that may weigh on regulatory success.
Elevate and clearly communicate actual or potential issues to stakeholders and management.
Serve as the CMC Product Lead for assigned products and be accountable for the delivery of all regulatory milestones for assigned products through the product lifecycle.
Lead development and execution of global product and project regulatory strategy(ies) by ensuring robust assessment of CMC changes, identification of global regulatory requirements and critical evaluation of supporting documentation to confirm acceptability and identification of potential risks.
Develop and Lead strategy discussion for Complex submissions (MAA, Major change, Multiple bundled changes etc)
Authoring/ update and review of CMC submission components (Module 1, 2.3 and 3)- quality submission packages be delivered back to client RA CMC in a light/no-touch model to support post-approval supplements, annual reports, registration renewals and responses to health authority questions per established business processes and systems.
Provide regulatory leadership as needed to product in-license/due diligence review, product divestment and product withdrawal.
Collaborate with client and external partners to support compliant execution of change management and conduct all activities with an unwavering focus on regulatory conformance.

Requirements:

Prepare status updates for all internal and external stakeholders
Update and maintain Job aid for the specific role, as applicable -Update and maintain tracker, checklist for specific processes, update RA tracking systems as applicable.
Knowledge and support for GMP submissions
Provide inputs to project regulatory strategies by performing assessments and evaluation of CMC changes in client change management systems.
To review scientific information to assess technical merits and suitability of scientific rationale to ensure information is presented clearly and conclusions are adequately supported by data.
Lead client meetings and managing project governance.
Assess and communicate potential regulatory risks to Stakeholders including Global regulatory team as necessary and propose mitigation strategies, Demonstrated problem-solving ability.
Work with cross-functional teams (such as Supply, Site Quality and Technical SME leads) to track and follow up outstanding documentation, coordinate on project status & reporting to stakeholders using different communication channels.
Efficient oral and written communication skills and the ability to communicate issues in a succinct and logical manner. Strong listening skills.
To be able to generate innovative solutions to problems and effectively collaborate with and communicate to key stakeholders.
Demonstrate flexibility in responding to changing priorities, multi-tasking and dealing with unexpected events.
Demonstrated effective leadership, communication, and interpersonal skills.
Understands complex pharmaceutical environments and multiple stakeholder importance.
Technology savvy to work on client systems, not limited to - document management system, change control management system, registration management system.