One of the leading top 10 pharma companies that employs over 5,000 people worldwide, is seeking a Senior Manager of Regulatory Affairs to join their team in Hertfordshire, UK. This is a permanent role.
To apply a broad knowledge and interpretation of regulatory requirements in Growth Markets and company products to the drug development process, including promulgation of health authority marketing authorization dossiers to enable efficient and effective registration of medicinal products consistent with the supported regions commercial objectives. Ensure that regulatory documentation meets relevant regulatory requirements and company quality standards.
- Contact with clients and external vendors and troubleshooting routine client inquiries. May represent the organization as a prime contact for technical matters of significant complexity
- Develops and implements regulatory strategy for own functional area and region
- Leads issue resolution of regulatory risks by identifying, escalating and monitoring issues
- Organizes resources and processes across multiple teams / functions to develop and deliver complete regulatory submissions within agreed timeframes.
- Provides regulatory support to project teams for allocated projects
- Contributes to the planning, execution, and assessment of product life cycle management activities and strategies
- Contributes to, and implements, strategy for interactions and negotiations with health authorities
- May autonomously handle routine communications with regulatory authorities
- Enhances the capabilities of current resources (tools, systems, vendors, etc.), technologies, and processes for the team
- May manage contractors and ensure that contractors, consultants and vendors complete assigned work according to agreed timelines
- Resolves expense issues and manages costs of work teams before issues arise
- Manages team finances in compliance with financial standards and guidelines
- Assist the review of 3rd party (contractors, consultants and vendors) work product and deliverables to recommend approval of payment of invoices or escalate issues when appropriate
Education and Experience:
- BS/MS in relevant field
- Experience in regulatory methods and processes in industry setting required
- Has experience developing regulatory strategies for NDA's/MAA's/significant line extensions/ CMC lifecycle management
- Has cultural awareness and experience of working with people from different cultural backgrounds.
- Is able to undertake long distance travel, some of which may necessitate travel at weekends
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please call Elise Stewart on +44 207 4400 633 or upload your CV on our website - www.proclinical.com.
A full job description is available on request.
ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.