Lead - Regulatory Affairs Compliance
Lead - Regulatory Affairs Compliance
Posted on :
10-02-2025
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1 Vacancy
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Monthly Salary
Not Disclosed
Salary Not Disclosed
Vacancy
1 Vacancy
Posted on :
10-02-2025
Job Description
Job Title: Lead Regulatory Affairs & Compliance (GDP RP & WQP)
Job Location: StokeonTrent UK
Job Location Type: Hybrid
Job Contract Type: Fulltime
Job Seniority Level: MidSenior level
Our 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
#INDWC
We'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 Role
The 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 everevolving 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 23 days on site and remote work with occasional travel to various UK sites.
Primary Duties And Responsibilities
The responsibilities of an RP (as set out in GDP and MHRA guidance) include:
Legislation Monitoring and Compliance:
Benefit 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 time
Affiliated Companies
Affiliated Companies: Centaur Services
Equal Employment Opportunity
Cencora 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 nondiscriminatory.
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 requestbyrequest basis. Messages and emails regarding anything other than accommodations requests will not be returned
Job Details
#INDWC
We'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 Role
The 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 everevolving 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 23 days on site and remote work with occasional travel to various UK sites.
Primary Duties And Responsibilities
The 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 selfinspections 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.
Legislation 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.
- 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.
- Provide timely regulatory advice to various business units as needed.
- Support teams in understanding and implementing regulatory requirements.
- Lead (dependent on risk) or assist in 'for cause' audits addressing highrisk nonconformities reported within the organization.
- Prepare documentation and support audit processes as required.
- Assist in conducting thorough investigations into lost medicine incidents.
- Review findings and contribute to corrective actions to prevent recurrence.
- 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 as necessary to various UK sites for audits workshops training sessions or other regulatory activities.
- 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.
- Detailoriented 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.
- Competitive salary & excellent company benefits
- An opportunity to work for a global purpose driven organization and make a difference.
Benefit 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 time
Affiliated Companies
Affiliated Companies: Centaur Services
Equal Employment Opportunity
Cencora 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 nondiscriminatory.
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 requestbyrequest basis. Messages and emails regarding anything other than accommodations requests will not be returned
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Employment Type
Full Time
Key Skills
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