Regulatory Affairs Manager

Katalyst HealthCares and Life Sciences • Full-time • Canton, MA, US • $120k - $160k / year • 2w ago

Responsibilities:

The Senior Manager, Global Regulatory Affairs Chemistry, Manufacturing, and Controls (GRA-CMC) Combination Products will be responsible for leading, developing, and implementing global CMC regulatory strategy related to Alexion's drug/device portfolio, in vitro diagnostics and clinical decision software leading to successful registration and life-cycle management of unique and technologically complex products.
The Senior Manager will manage teams and complex projects for global CMC submissions with device aspects and responses to regulatory agency inquiries for Alexion's commercial and investigational products.
Independently manage and accountable for assigned CMC programs, managing day-to-day delivery of plans and strategic activities for specific projects, including Life Cycle Teams and compliance of clinical and commercial products.
Establish effective collaborations to ensure regulatory strategies for precision medicine, digital health and medical devices accommodate drug regulatory and submission plans including HA engagements and risk mitigations.
Be the Alexion designated employee with regulatory expertise to ensure compliance with the FDA QSR, Clinical Decision Software, EU MDR, and EU IVDR.
The PRRC is responsible for ensuring.
The conformity of the devices is appropriately checked, in accordance with the quality management system under which the devices are manufactured, before a device is released.
The technical documentation and the EU declaration of conformity are drawn up and kept up to date.
Plan, coordinate, and manage the development, preparation and submission of the CMC sections of Alexion's investigational and registration dossiers, supplements, and renewals for commercial products.
Dossier preparation will include new country submissions and post-approval changes.
Develop proactive regulatory strategies for global CMC product lifecycle management, with limited oversight.
Present CMC strategies and plans to Alexion management and appropriate core teams.
Effectively build and lead project teams for CMC submissions.
Create and maintain detailed project plans to ensure clarity of deliverables and timing through the use of project management tools and principles.
Constantly monitor and evaluate GRA-CMC team's progress towards meeting milestones and timelines, through active communication and review of pertinent information.
Identify and monitor critical path activities and develop contingency plans.
Publish clear and concise meeting agendas, minutes, and action items.
Track action items through to completion.
Provide feedback to management of project progress / scope changes / risks and impact to timelines.
Drive timely decisions and facilitate active communication and information flow between team members, senior management and impacted sites / functional areas.
Research and provide interpretive analyses of regulatory guidance documents, regulations, or directives that impact CMC for assigned countries.
Operates independently to resolve complex issues and manage regulatory risks and ambiguous situations within project teams.
Investigates opportunities for regulatory innovation / promote the use of Client approaches within project team to resolve issues and problems.
Prepare responses to health authority questions and comments; prepare briefing packages as assigned.
Interfaces directly with Health Authorities in order to discuss and define regulatory applications.
May act as CMC representative in formal meetings and teleconferences with regulatory authorities.

Requirements:

Bachelor's degree in relevant scientific discipline.
Minimum of 7 years of experience in Regulatory and/or Regulatory-CMC, medical device, clinical decision software/digital health and in IVD experience with some experience within EU is a requisite.
4-years of professional experience in regulatory affairs or in quality management systems relating to medical devices in the EU.
Relevant technical experience in biopharmaceutical or related experience in a scientific discipline with additional technical / project education or training.
Strong written and oral communication skills; comfortable communicating with and building relationships with numerous stakeholders in a cross functional environment.
Candidates are required to have a broad functional knowledge of pharmaceutical sciences industry, with a clear understanding of drug development/commercial manufacturing of biopharmaceuticals.
Work closely with representatives of Regulatory Affairs including in-country regulatory leads, Diagnostics and Precision Medicine, Digital Health, Drug Delivery and Device Development, Manufacturing, Technical Services, Process Development, Quality and other key partners both internal and external to the company.
Provide guidance and expertise on assigned GRA-CMC documents/projects.
Ensure that the quality and content of CMC documentation is complete and complies with applicable regulations and regulatory/scientific guidelines and in accordance with Alexion's strategic initiatives and policies.
Ensure that appropriate CMC documentation is filed and archived in designated systems.

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