Senior Manager, Biologics Regulatory CMC
Senior Manager, Biologics Regulatory CMC
Viatris
Sandwich, United Kingdom
This role is responsible for the implementation of global CMC regulatory strategies specific to Viatris’s Biologics and biosimilars products. Working in partnership with key stakeholders including Project Management, QA, Manufacturing, CMC, regional teams and external partners, ensuring regulatory CMC requirements are built into project plans such that the products are positioned for successful approvals in all markets. Will lead the preparation of high-quality Regulatory CMC documents in compliance with current guidance and regulations. Support and take part in interactions with global Regulatory Agencies as required in order to facilitate product development, registration and lifecycle management.
Key responsibilities for this role include:
- Support/develop global Regulatory CMC strategies for Viatris’s Biologics products to facilitate overall program goals.
- Provide Regulatory CMC expertise on cross-functional project teams, working with external partners, suppliers and contract manufacturers, as required in order to ensure regulatory CMC requirements are built into project plans and CMC components of regulatory submissions are positioned for successful approvals.
- Develop and maintain positive working relationships with internal and external partners to facilitate efficient accomplishment of regulatory goals.
- Participate in/lead the preparation of CMC components of regulatory submissions including clinical trial and variations/supplements as well as filing submissions for major markets ensuring alignment with regulations, guidelines and Viatris’s policies and procedures.
- Ensure quality and timelines are met for all pre and post approval submissions through active management of CMC regulatory submissions, including review, quality checks, logging and tracking of documents.
- Manage Regulatory CMC aspects of post approval change controls, liaising with relevant personnel as well as manufacturing partners to ensure regulatory compliance.
- Contribute to the preparation of CMC aspects of documents for regulatory agency interactions. May also represent Regulatory CMC at agency meetings.
- May provide regulatory CMC expertise into in-licensing activities or new product developments.
- Contribute to the improvement, design and implementation of Company Regulatory processes and procedures where appropriate.
- Maintain and expand regulatory CMC expertise for self and colleagues.
- May Contribute to Viatris Biologics external Influencing through representation on relevant organisations, attendance and presentation at conferences.
- May support Pre-Approval Inspections (PAI) and launch activities as required.
The minimum qualifications for this role are:
- Bachelor's degree (or equivalent) in a science related field (minimum).
Essential skills and experience for this role are:
- Demonstrable experience in the pharmaceutical industry and some experience developing biological products.
- Broad functional knowledge of pharmaceutical sciences and a clear understanding of drug development and/or manufacturing/improvement processes.
- Must possess excellent communication skills, both oral and written.
- Ability to read and interpret complex business and/or technical documents.
- Ability to write comprehensive reports and detailed business correspondence.
- Good interpersonal skills with ability to multitask.
- Strong technical background and organisational skills.
- Accuracy and attention to detail required.
- Computer skills including Microsoft Word, Excel and PowerPoint are preferred
