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Regulatory Affairs, Director

Job in England - UK
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Company: MEDA Pharma GmbH & Co. KG
Full Time position
Listed on 2021-05-06
Job specializations:
  • Science
  • Pharmaceutical
    Pharmaceutical Manufacturing, Pharmaceutical QA, Biopharma
Job Description & How to Apply Below
Location: Cheshire
Access – Providing high quality trusted medicines regardless of geography or circumstance;
Leadership – Advancing sustainable operations and innovative solutions to improve patient health; and Partnership – Leveraging our collective expertise to connect people to products and services. Every day, we rise to the challenge to make a difference and here’s how the Regulatory Affairs, Director role will make an impact:
Key responsibilities for this role include:
To guide, develop, and execute regulatory strategies for Viatris Major Markets for designated products within the global respiratory and biologics group. Interface with key internal stakeholders including Project Management, Preclinical, Clinical, Regulatory CMC, Devices and Pharm Sciences Teams. Manage the China regulatory respiratory portfolio, interfacing with the local, office, CRO’s and Regulatory Agency, building CTA’s and NDA’s as required. Lead engagement with Key Regulatory Agency’s Worldwide including US, EU, Canada, Australia, New Zealand and Japan and other regulatory agencies as required to build regulatory strategies as part of the portfolio.

Provide leadership to the MGRG to develop tactical plans for respiratory products as assigned. Ensures that regulatory strategic and tactical activities meet development milestones and ultimately gain acceptance and approval of the marketing application by the relevant regulatory authorities. Ensure timely submission and approval of Regulatory deliverables to support the portfolio, such as IND’s, CTA's, NDA’s, MAA’s. Lead preparations and interactions for Major Markets Regulatory Authority meetings.

Provide high quality and current regulatory advice internally to development teams and externally to development partners. Review technical documentation/dossiers for compliance with legislation and provide feedback on the suitability of the documentation for obtaining Marketing Authorisations. Be active in the design and development and implementation of Company Regulatory processes and procedures, where appropriate. Lead preparation, submission and review of Marketing Authorisations, in accordance with relevant directives, regulations, guidelines National requirements and Mylan company policies and procedures.

Manage the day to day regulatory work to ensure that project The minimum qualifications for this role are:
Excellent communication skills, written and verbal, and experience with Microsoft Word and Microsoft Excel. Substantial experience and proven track record in regulatory affairs.

Experience of dossier preparation and submission.

Experience of managing R&D global regulatory projects with awareness of and experience of US, EU, CA, Aus, NZ, Japan and China. Regulatory experience of building and managing China regulatory submissions desirable. Minimum of a science or technical qualification, ideally a Bachelor’s Degree, Advanced Degree (MSc, PhD) Preferred. Substantial experience and proven track record in regulatory affairs and in an R & D environment.

Willing to work in multidisciplinary team/s Desire and ability to learn and develop Flexible & resilient, ability to manage change. Communicates effectively with partners and governance. At Viatris, we offer competitive salaries, benefits and an inclusive environment where you can use your experiences, perspectives and skills to help make an impact on the lives of others.
Note that applications are not being accepted from your jurisdiction for this job currently via this jobsite. Candidate preferences are the decision of the Employer or Recruiting Agent, and are controlled by them alone.
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