Lead – Regulatory Affairs & Compliance

Job title:

Lead – Regulatory Affairs & Compliance

Company

Lifelancer

Job description

Job Title: Lead – Regulatory Affairs & Compliance (GDP RP & WQP)Job Location: Stoke-on-Trent, UKJob Location Type: HybridJob Contract Type: Full-timeJob Seniority Level: Mid-Senior levelOur team members are at the heart of everything we do. At Cencora, we are united in our responsibility to create healthier futures, and every person here is essential to us being able to deliver on that purpose. If you want to make a difference at the center of health, come join our innovative company and help us improve the lives of people and animals everywhere. Apply today!Job Details#INDWCWe’re hiring a Lead – Regulatory Affairs and Compliance (GDP RP & WQP) to join our dynamic team at MWI – Stoke on Trent.This position offers an exciting opportunity for individuals passionate about regulatory affairs who wish to contribute significantly towards maintaining compliance integrity within a leading pharmaceutical solutions organization.The RoleThe Regulatory Affairs & Compliance Lead will report to the Regulatory Affairs & Compliance Manager and will become the second Wholesale dealers Qualified Person (WQP) and Responsible Person (RP) named on the Veterinary and Human wholesale dealers licences.They will play a critical role in ensuring the business remains compliant with the ever-evolving legislation surrounding the wholesale distribution of human and veterinary medicines in the UK.From time to time this role may require engagement with other business units belonging to parent company Cencora. This may require flexibility to find a mutually workable time across all time zones.This role is hybrid, involving approximately 2-3 days on site and remote work, with occasional travel to various UK sites.Primary Duties And ResponsibilitiesThe responsibilities of an RP (as set out in GDP and MHRA guidance) include:

• Ensuring that a quality management system is implemented and maintained;
• Focusing on the management of authorised activities and the accuracy and quality of records;
• Ensuring that initial and continuous training programmes are implemented and maintained;
• Coordinating and performing any recall operations for medicinal products;
• Ensuring that relevant customer complaints are dealt with effectively;
• Ensuring that suppliers and customers are approved;
• Approving any subcontracted activities that may impact on GDP;
• Ensuring that self-inspections are performed at appropriate regular intervals following a prearranged programme and necessary corrective measures are put in place;
• Keeping appropriate records of any delegated duties;
• Deciding on the final disposition of returned, rejected, recalled, or falsified products;
• Approving any returns to saleable stock;
• Ensuring that any additional requirements imposed on certain products by national law are adhered to.

Additional RequirementsLegislation Monitoring and Compliance:

• Continuously monitor and stay up to date with changes in legislation related to the wholesale distribution of human and veterinary medicines in the UK.
• Interpret regulatory updates and communicate their impact on business operations.

Licence Management

• Ensure that human and veterinary wholesale licences are kept up to date.
• Submit variations as required to capture business changes ensuring compliance with regulatory requirements.

Regulatory Advisory

• Provide timely regulatory advice to various business units as needed.
• Support teams in understanding and implementing regulatory requirements.

Audit

• Lead (dependent on risk) or assist in ‘for cause’ audits addressing high-risk non-conformities reported within the organization.
• Prepare documentation and support audit processes as required.

Lost Medicine Investigations

• Assist in conducting thorough investigations into lost medicine incidents.
• Review findings and contribute to corrective actions to prevent recurrence.

Training And Workshops

• Support the creation, planning, and facilitation of workshops aimed at addressing knowledge gaps in Good Distribution Practice for medicines.
• Facilitate business continuity compliance workshops to ensure preparedness across all departments.
• Organize corporate risk management workshops to identify, assess, and mitigate potential risks to the organization.

Travel Requirements

• Travel as necessary to various UK sites for audits, workshops, training sessions, or other regulatory activities.

Experience, Skills And Knowledge Requirements

• A Diploma, certificate or other evidence of formal qualifications awarded on completion of a university or other higher education course of study in pharmacy, chemistry, medicine, biology or a related life science.
• Proficiency in interpreting complex regulations and guidelines.
• Experience and qualification in internal audit beneficial.
• Experience in external audit, externally recognized qualification beneficial.
• Confidence and ability to provide clear advise to all levels of stakeholder.
• Ability to work independently as well as collaboratively within a team environment.
• Detail-oriented with strong analytical and problem solving skills.
• Effective organizational skills with the ability to manage multiple tasks simultaneously.
• Willingness to travel across various UK sites as necessary.

What We Offer

• Competitive salary & excellent company benefits
• An opportunity to work for a global purpose driven organization and make a difference.

What Cencora offersBenefit offerings outside the US may vary by country and will be aligned to local market practice. The eligibility and effective date may differ for some benefits and for team members covered under collective bargaining agreements.Full timeAffiliated CompaniesAffiliated Companies: Centaur ServicesEqual Employment OpportunityCencora is committed to providing equal employment opportunity without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, age, disability, veteran status or membership in any other class protected by federal, state or local law.The company’s continued success depends on the full and effective utilization of qualified individuals. Therefore, harassment is prohibited and all matters related to recruiting, training, compensation, benefits, promotions and transfers comply with equal opportunity principles and are non-discriminatory.Cencora is committed to providing reasonable accommodations to individuals with disabilities during the employment process which are consistent with legal requirements. If you wish to request an accommodation while seeking employment, please call 888.692.2272 or email . We will make accommodation determinations on a request-by-request basis. Messages and emails regarding anything other than accommodations requests will not be returnedLifelancer ( ) is a talent-hiring platform in Life Sciences, Pharma and IT. The platform connects talent with opportunities in pharma, biotech, health sciences, healthtech and IT domains.For more details and to find similar roles, please check out the below Lifelancer link.

Expected salary

Location

Stoke-on-Trent

Job date

Tue, 11 Feb 2025 23:43:53 GMT

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