Cmc regulatory specialist

Overview of the Position

The Regulatory CMC Specialist will work closely with the Regulatory Site Office, Manufacturing and Supply teams, and CMC colleagues on Vaccines site-based projects to achieve submissions and approvals in key markets and to maintain regulatory compliance for License registrations in existing markets.

The position is based in Swiftwater, PA USA. This is a hybrid position.

Mission

The Regulatory CMC Specialist in Regulatory Site Office supports regulatory compliance for marketed products by means of compliant and timely handling of regulatory activities at Swiftwater.

The incumbent manages regulatory activities linked to change controls for the site, including the update of CMC files. The incumbent is accountable for product license maintenance and site registrations.

The incumbent also ensures the role of regulatory expert for regulatory topics and projects at the Swiftwater and Pearl River sites.

Duties and Responsibilities

The Regulatory CMC Specialist may have responsibility for one or more products or activities in the RSO Vaccines group.

The Regulatory CMC Specialist, manages authoring of CMC regulatory documents (modules 1.2, 2.3 and 3) to support Marketing Authorizations and other documentation that support site registrations, specific country documentation, and Annual reports.

The Regulatory CMC Specialist prepares responses to Health Authority questions related to CMC from Regulatory affiliates with the contribution of site experts.

The Regulatory CMC Specialist may participate in transversal activities by serving as Regulatory interface between M&S, MSAT and GRA.

The Regulatory CMC Specialist will ensure Regulatory compliance by providing support to batch release by checking submission / approvals, ensuring permanent regulatory / license compliance and reviewing and approving site documents (e.

g. Standard Operating Procedures).

The Regulatory CMC Specialist may represent RSO on M&S and MSAT project teams when product or valence-related regulatory site expertise is required.

Key Accountability

Regulatory Compliance :

Supports batch release by following submission and approval to ensure the product regulatory compliance on his / her sites(s)

Response to agency lot release questions

Ensures that the CMC dossier is in line with manufacturing and control procedures on site(s) and with dossiers approved by Health Authorities

Prepares and provides Regulatory documentation required for site registration and renewal activities

CMC Documentation Management :

Writes and approves CMC regulatory documents / dossiers to be dispatched to regulatory affairs functions for submissions

Coordinates CMC writing performed by another entity (internal or external)

Optimizes the content of CMC dossiers to facilitate the management of future changes

Prepares response to questions from Health Authorities with contribution of site experts

Supports Marketing Authorizations worldwide (territory extensions, renewals, site registrations and transfers, etc.) by writing the corresponding CMC documents / dossiers and collecting GMP related documents from the site(s)

Consolidates regulatory activities in a planning tool

Transversal Activities :

Contributes to Regulatory intelligence on the specific field of competencies and communicates the appropriate information to the site

Contributes to the implementation of the appropriate company tools to manage activities

Attends and contributes Regulatory site expertise to designated Projects, Committees, Team meetings

May contribute to Critical Process Analysis and Testing Strategies

Organizational Reporting and Communication :

Responsible for reporting on the progress and specific issues pertaining to project / product responsibilities.

Planning / Coordination : As per the assignment, the incumbent will support or work jointly with other Regualtory Affairs functions, and project managers for the planning and coordination of regulatory CMC activites relating to projects / products from intiation to approval, which include :

Detailed plan prioritization and coordination of activities with Liason / Franchise groups

Supporting CMC related regulatory objectives and target dates

Providing timelines for critical CMC regulatory activities to be incorporated into the project plan

Regulatory Guidance : Responsible for contributing to site regulatory advice and guidance to Project / Product Team members and other functional areas on regulatory matters. This could include :

Providing information from regulatory requirements documents and other appropriate guidance documents.

Personal Development / Training : Responsible for staying up-to-date on regulatory guidances and technical / scientific developments.

Maintaining 100% compliance on all assigned and alpplicale training on a regular basis.

Knowledge, Skills & Competencies

Strong authoring skills of CMC documentation and Health Authority responses

Ability to resolve strategic technical and regulatory issues

Should demonstrate initiative, analytical thinking and works independently

Ability to work well with cross functional teams, and good communication skills with internal and external stakeholders

Experience working with a Health Authority is helpful but not essential

Knowledge of global regulations / guidelines, key Health Authority / Industry Guidance and trends are helpful

Qualifications

Education / Experience

Bachelor's degree in Biological Sciences with 2 years Regulatory Affairs experience OR Master's degree in Regulatory Affairs / Quality Assurance or an appropriate combination of other relevant industry experience e.

g., Quality and / or Manufacturing

Requires knowledge and understanding of CMC topics, as well as North American, European and International regulations / guidelines

Ability to manage multiple priorities efficiently

Experience working on Project teams

Demonstrated knowledge of microbiology, immunology, virology or bacteriology

Excellent skills in communication, writing and teamwork

Certifications

Last updated : 2024-11-26