At a Glance
- Tasks: Lead regulatory compliance and post-approval activities in a dynamic pharmaceutical environment.
- Company: Growing generic pharmaceutical company with a focus on innovation.
- Benefits: Competitive salary, professional development, and a collaborative work culture.
- Other info: Onsite role with opportunities for career advancement.
- Why this job: Join a team making a real impact in the pharmaceutical industry.
- Qualifications: Pharmacy/Chemistry degree and 7-10 years of Regulatory Affairs experience required.
The predicted salary is between 60000 - 75000 £ per year.
An exciting opportunity for an experienced Regulatory Affairs Manager to take on a new role in a growing generic pharmaceutical company working towards a portfolio of 220 licenses. Please note that this role will be onsite 5 days per week.
Responsibilities:
- Primarily responsible for post-approval and compliance activities with a support role for the pre-approval team.
- Have an excellent understanding of and be able to execute activities related to the following key areas:
- Variations: Type 1A, 1B, II, Labelling changes including own label supplies, safety updates and line extensions.
- Reclassification of Medicines.
- Re-baseline / Remediation dossiers.
- License Transfers (giving away and bringing in) including the due diligence of dossiers.
- Maintenance of Marketing Authorisations including renewals.
- Deficiency responses to authorities.
- Interfacing with regulatory authorities to facilitate the approval of submissions.
- Work with sites (manufacturing, PV service provider)/appropriate personnel/departments to ensure regulatory requirements are met and resolve any outstanding regulatory issues.
- Act as the primary contact point for Regulatory Affairs with the business units, customers, and other internal/external teams.
- Stay informed about new and changing regulatory requirements and ensuring compliance.
- Work with QPPV on PSUR submissions, update SmPC and labelling in line with the Company Core Data sheets.
- Liaise with regulatory authorities for advice and guidance when necessary, and to resolve issues to achieve the best possible outcome for the business.
- Maintain up-to-date records and documentation in relation to Marketing Authorisations.
- Carry out duties in line with regulatory, commercial, quality and business needs and ensuring compliance with regulatory legislation and guidelines, and company processes and procedures.
- Support other regulatory staff members within the Company when necessary.
- Assist in preparation of procedures (SOPs) for relevant regulatory activities, and in preparation and review of procedures for other areas.
- Any other task given to you by relevant stakeholder in order for you to be able to perform your role.
Required Skills:
- Pharmacy/Chemistry degree.
- 7-10 years Regulatory Affairs experience.
- Understanding of the current UK and European regulations, laws, guidelines and industry requirements.
- Experience with Generic products and MRP/DCP submissions is advantageous.
- Clear understanding and ability to manage:
- National Procedure (MHRA).
- MRP, DCP – Preferable.
- Any other regulatory body submissions – Added advantage.
- Usage of Submission Gateways and Tools; MHRA Portal, Eudralink, CESP.
- Exposure to NeeS/eCTD format and electronic submission gateways is preferable.
Regulatory Affairs Manager employer: Select Pharma Recruitment
Join a dynamic and innovative pharmaceutical company that values compliance and integrity, offering a supportive work culture where your expertise in Regulatory Affairs will be recognised and rewarded. With a strong focus on employee development, you will have access to continuous training and growth opportunities, all while working in a collaborative environment that prioritises teamwork and open communication. Located in a thriving area, this role not only provides a chance to make a significant impact but also offers a fulfilling career path in a sector dedicated to improving health outcomes.
