Head of Regulatory Affairs and Pharmacovigilance

Head of Regulatory Affairs and Pharmacovigilance Job Reference: J5639147Status: Open to ApplicationsUpdated: 26/04/2024 Role Overview We are currently looking for a Head of Regulatory Affairs and Pharmacovigilance to join a leading Pharmaceutical company based in the Kent area. As the Head of Regulatory Affairs and Pharmacovigilance you will be responsible for providing organisation with strategic advice for the launch of new products in EU & UK. Key Duties and Responsibilities Your duties as the Head of Regulatory Affairs and Pharmacovigilance will be varied however the key duties and responsibilities are as follows:1. Define and lead regional strategies to optimize Regulatory and Pharmacovigilance outcomes, effectively communicating potential advantages and disadvantages to management.2. Maintain in-depth knowledge of MA Transfer requirements in EU territories, including notarisations and translations.3. Provide oversight to a team of four, ensuring seamless day-to-day operations in Regulatory and Pharmacovigilance departments.4. Ensure adherence to CMC practices in line with regulatory authority standards, review bio-waiver declarations, and quality overall summaries. Role Requirements To be successful in your application to this exciting opportunity as the Head of Regulatory Affairs and Pharmacovigilance we are looking to identify the following on your profile and past history:1. Educated to degree level in science or equivalent professional experience.2. Proven industry experience in Regulatory Affairs.3. Proficiency in MS Office suite, including Excel and PowerPoint.4. Initiative and the ability to collaborate effectively across various departments.Key Words: Regulatory Affairs Manager | Pharmacovigilance | Regulatory Strategies | MA Transfer | EU Regulations | CMC Practices | Bio-waiver | Quality Summaries | Pharmaceutical | Translations | CMC |
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Hyper Recruitment Solutions Ltd (HRS) is an Equal Opportunities employer who are certified by Investors in People for our talent development. We welcome applications for any applicant who fulfil the role requirements for this position. HRS is a company exclusively supporting the science and technology sectors, and is made up of a collaboration of recruitment professionals and scientists. We look forward to helping you with your next career moves.
Sectors:
Pharmaceutical
Skills:
Regulatory Affairs - Permanent,
Regulatory Affairs - EU,
Regulatory Affairs - UK,
Pharmacovigilance - PV - Perm,
Pharmacovigilance - PV Director / Head of
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