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We are currently looking for a Senior Manager of Regulatory Affairs to join a leading Pharmaceutical company based in the Berkshire area. As the Senior Manager of Regulatory Affairs you will be the lead person in the company on all Regulatory matters. You will ensure that new products are developed in line with global regulatory requirements of targeted countries, obtain expedient registration of these products in a cost effective, timely manner and maintains the registrations of existing products in compliance with applicable legislation.
KEY DUTIES AND RESPONSIBILITIES:
Your duties as the Senior Manager of Regulatory Affairs will be varied however the key duties and responsibilities are as follows:
1. Develop regulatory strategies for development projects and manufacturing improvements, analyses risk vs. benefit in regulatory strategies to ensure successful review by regulatory authorities. You will take the lead on negotiating submission data requirements and deliverable dates with regulatory authorities and internal technical teams.
2. Manages the preparation of registration dossiers and submission of Marketing Authorisation Applications in line with regulatory authority requirements and responds to deficiency letters in a timely manner. Liaises with licensing partners or affiliate companies to ensure submissions of MAAs in their territories can be successful.
3. As the Senior Manager of Regulatory Affairs you will provide managerial support and training to employees by supervising staff, establishing employee goals that align with other business partners, maintaining job descriptions, creating employee development plans, providing performance feedback and recruiting, motivating and retaining staff members
4.Supports the marketing, commercial and business development functions of the company with regard to the handling of enquiries and New Product Development project related activities (query management, product due diligence, dossier development, etc). You will also manage the routine Marketing Authorisation maintenance activities CP/DCP/MRP/National including compilation and submission of variations and renewals.
To be successful in your application to this exciting opportunity as the Senior Manager of Regulatory Affairs we are looking to identify the following on your profile and past history:
1. Relevant degree in a life science / science discipline (i.e Chemistry / Pharmaceutical Management / Life Sciences) with significant experience in the Pharmaceutical industry focused around medicinal and medical device regulatory development and life-cycle maintenance activities
2. Proven industry experience in EU regulatory affairs within development and established products environments, as well as direct exposure to working with regulatory agencies, especially EMA, MHRA and FDA.
3. As this is a personnel management role of a mutli disciplinary Regulatory Affairs department, it is critical you have prior experience in managing people including the development, coaching and recruitment of the team.
Key Words: Regulatory Affairs / Management / Regulatory Management / Senior Manager / Pharmaceutical Development / EU Regulations / European Regulatory Affairs / MHRA / EMA / FDA
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 processionals and scientists. We look forward to helping you with your next career moves.