Description
The successful candidate will- Provide full regulatory support for the companys products across European markets and support new opportunities in key emerging and established markets as necessary.
- Manage and coordinate Labelling, Publishing and CMC teams for various Regulatory Submissions.
- Prepare/review regulatory strategies for the registration of products
- Execute defined regulatory strategies and priorities through effective partnership with the wider organization.
- Prepare responses to deficiency questions from the agencies.
- Maintain all existing pharmaceutical product marketing authorisations and gain European regulatory authority approval for the amendment of these authorisations as required through variations or notifications.
- Prepare renewal applications according to internal procedures and agency expectations.
- Liaise with manufacturing sites, corporate functions and European affiliate departments on regulatory and allied (QA, GMP, GPO) issues.
- Liaise with external regulatory authorities as required.
- Provide necessary Module 1, labelling and CMC regulatory documents.
- Filing Repeat Use procedures with the potential markets
- Provide representation of EU Regulatory Affairs on internal working teams/groups to comply with the companys policies and procedures to meet statutory, quality and business requirements within the overall strategy and objectives
Essential:
- Relevant life science degree
- Strong knowledge of the drug development process and regulatory requirements
- Experience in preparing regulatory submissions and supportive amendments or supplements
- Highly organised with good computer skills
- Strong written and verbal communication skills
- Demonstrated ability to work effectively both individually and as part of an established team