Senior Regulatory Affairs Manager - Medicines, Medical Devices & Cosmetics

As a Senior Regulatory Affairs Manager, you will be a vital member of our regulatory affairs function, responsible for setting the strategic direction and, working with expert third party advisors, ensuring compliance with all relevant regulations and guidelines governing our products and operations. Reporting directly to the Group Head of Product Integrity, you will play a crucial role in developing and executing regulatory strategies, leading regulatory submissions, and managing a team of Regulatory Affairs Associates. Your expertise and leadership will contribute to the successful market authorisation and ongoing compliance of our products., Regulatory Strategy and Compliance:

• Provide a RA oversight function and full working knowledge of entire H&B traditional herbal remedy (THR) medicines, medical devices, and cosmetics product portfolio.


• Be responsible for reviewing and performing a gap analysis of all product registration dossiers for THR and medical devices products currently on the market and in production. Cross-referencing against any files/data held by any third-party vendors as necessary.


• Be responsible for regulatory compliance of H&B and branded cosmetics product portfolio.


• Planning and performing a full-remediation project as necessary to ensure alignment across Regulatory Dossiers, Product Specification files, third party data and data held by NCAs.


• Develop and implement regulatory strategies in collaboration with cross-functional teams to facilitate product approvals and ensure compliance with applicable regulatory requirements.


• Monitor and interpret changes in regulatory guidelines and communicate the impact on the organisation's products and activities.


• Ensure adherence to relevant laws, regulations, and standards for each market in which our products are distributed.


• Support the approval and onboarding of branded GSL medicines for retail at H&B,


Quality Management System and Regulatory Affairs systems:

• Work as part of a multi-disciplinary team to develop and improve regulatory affairs systems and processes for the management of H&B THR, medical device, and cosmetic products regulatory activities including change control and LCM activities.


• Develop or source a registration dossier database for THR, medical devices, and cosmetic products including central repository for regulatory correspondence. Review and develop and an-house regulatory filing system in order to ensure that Product Specification Files and regulatory dossiers are fully up-to-date, and information is easily accessible and retrievable.


Regulatory Submissions:

• Oversee the preparation, review, and timely submission of regulatory applications, registrations, and reports to relevant authorities.


• Ensure accuracy and completeness of regulatory submissions to expedite the approval process.


• Be responsible for the proactive management and planning of ongoing product life cycle management for all medicines, medical devices, and cosmetic products and new product introductions.


Working with third party vendors

• Build an ongoing working relationship with any external vendors/CMOs responsible for any H&B THR/medical devices products to ensure alignment with product specifications held on file at CMO and H&B and maintain this going forward.


• Working in conjunction with any third-party vendors to which regulatory affairs activities are outsourced in order to ensure that accurate copies of any information are correctly filed and stored at H&B and that the working relationship with the vendor going forward enables regulatory affairs activities to be handled in an efficient and expeditious fashion.


Team Management:

• Line manage and provide leadership, guidance, and support to the Senior Regulatory Affairs Associate(s) in their daily activities.


• Foster a collaborative and high-performance culture within the regulatory affairs team.


• Conduct regular performance reviews and contribute to the professional development of team members.


Regulatory Intelligence:

• Stay abreast of evolving regulatory trends, guidelines, and best practices to drive proactive regulatory strategies.


• Share regulatory updates and insights with relevant stakeholders to inform strategic direction and decision-making.


• Serve as the primary point of contact for regulatory authorities and manage communications, queries, and inspections effectively.


Internal Collaboration:

• Build strong relationships and role model collaboration with cross-functional teams to ensure alignment on regulatory requirements and product compliance.


• Manage suppliers to provide regulatory guidance during product development, trials, and post-market activities.


• Work as part of any regular quality review meetings setup by Quality Assurance Manager/leadership in order to report and review ongoing regulatory activities/product complaints/ADR reports.


• Act as the key "go to" RA contact with the H&B business who can provide efficient, accurate answers to queries on medicinal products and cosmetics and their associated registration dossiers etc.


• Must work closely with SLT representative to ensure any potential RA impact of any business decisions fed back to SLT). Be involved and consulted on any business activities/plans which may impact regulatory compliance of the business.
  
  Bachelor's degree in a scientific discipline, pharmacy, or a related field. An advanced degree (e.g., MSc, PhD) is preferred.


• Significant experience within the pharmaceutical and/or cosmetics sector in a regulatory discipline in UK and ROI markets.


• Experience/knowledge with Traditional Herbal Remedies and Medical Devices


• Experience/knowledge with Cosmetics preferred but not essential (willingness to receive training in this area if no relevant experience).


• A demonstrable level of previous experience in regulatory affairs management roles within the medicinal products sector.


• Proven track record of successful regulatory strategy development and execution, leading to product approvals and maintenance in relevant markets.


• Experience in managing regulatory submissions and interactions with health authorities.


• Strong knowledge of local and international regulatory requirements and guidelines pertinent to the organization's product portfolio.


• Previous experience in people management, providing mentorship, and fostering a collaborative team environment.


• Excellent communication and interpersonal skills, with the ability to liaise effectively with internal stakeholders and regulatory authorities.


• Strong attention to detail and ability to manage multiple projects simultaneously.


• Regulatory affairs certifications (e.g. RAC) are a plus.
  
  Our Benefits for this role include, but not limited to:


• H&B Employee Discount - 25%


• Bonus


• Pension company contribution


• 33 Days Holiday per year (Inclusive of bank holidays)


• Private Medical Care


• Exclusive benefits, free advice and savings from a range of retailers and providers


• Electric Car Scheme


We're passionate about helping every colleague thrive across all dimensions of wellbeing, and we're committed to having a diverse and inclusive workplace. In line with our EPIC values (Expertise, Pioneering, Inclusive, Caring), we embrace and actively celebrate all our colleagues unique and varying experiences, backgrounds, identities and cultures - I am me, we are H&B.

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Division: International City: Nuneaton Job Type: Full Time Number of Hours: 37.5 Contract Type: Permanent