Cencora is seeking an experienced Regulatory Affairs cum Pharmacovigilance OR Quality Management Control Manager. This role is essential to our purpose of creating healthier futures. You will be accountable for the operational execution within the Regulatory Strategy & Procedure Management Practice Area, managing activities for a diverse portfolio including human and veterinary medicinal products, medical devices, cosmetics, food supplements, and herbal products.
What You'll Do
- Develop and maintain strong client relationships and explore opportunities for increased service support.
- Participate in regulatory processes to gain and maintain marketing authorizations (applications, renewals, variations).
- Prepare, review, and compile documents for regulatory affairs projects and communicate with clients and Health Authorities.
- Support scientific advice procedures and represent clients with health authorities.
- Plan and execute client projects according to KPIs, coordinating project teams with colleagues and external partners.
- Provide general guidance to colleagues and clients regarding Regulatory Strategy and Procedure Management.
- Develop and maintain personal regulatory knowledge and apply it to client projects.
- Present seminars and lectures for colleagues, clients, and professional audiences.
- Support Value Delivery Centre strategy implementation, optimization, and commercial activities.
- Provide on-site regulatory support to Global Consulting Services clients.
- Set up and manage the local pharmacovigilance system, including oversight of all local Pharmacovigilance activities.
- Perform Local Literature Search, Individual Case Safety Report Collection and Management, and Pharmacovigilance Intelligence Screening.
- Maintain the Local Pharmacovigilance System Master File.
- Set up Local Organized Data Collection and manage Local Pharmacovigilance Agreements.
- Adapt and submit local Periodic Safety Update Reports and Risk Management Plans.
- Perform local signal detection and implement additional Risk Minimization Measures.
- Review materials relating to local post-authorization safety studies.
- Participate in Pharmacovigilance-relevant audits and inspections.
- Attend regular project meetings and provide monthly Pharmacovigilance reports.
- Ensure Pharmacovigilance training of affiliate employees, service providers, and Third Parties.
- Maintain the Quality Management system and perform Quality Management Reviews.
- Manage Change control, deviation, and Corrective and Preventive Actions.
- Manage Quality Technical Agreements.
- Conduct internal and external audits and Self-Inspections.
- Oversee 3rd Party Logistics/Local Distributors and local labelling activities.
- Perform local release of batches.
- Qualify suppliers and customers.
- Manage returns, quality product complaints, and incidents.
- Maintain Local Regulatory intelligence.
- Prepare Product Quality Review/Annual Product Review.
- Act as contact point to local regulatory authorities and serve as Local Responsible Person and/or Qualified Person where required.
What We're Looking For
- A university degree in Life Science.
- Proven experience, or demonstrable capability, in the area of responsibility or a similar field.
- Advanced knowledge and insights required to perform complex tasks and strong practical knowledge of the service area.
- Ability to implement tactical goals of customer or internal projects within daily work.
- Ability to prioritize parallel tasks, identify potential road blocks and initiate appropriate counter measures.
- A structured, analytical, systematic and independent way of working.
- Ability to analyze and solve problems and to develop pragmatic solutions.
- High service orientation.
- Ability to train and support junior/new colleagues in daily activities.
- Ability to lead small projects with clearly defined scope.
- Ability to manage internal and external (client) relationships on operational / day-to-day working level as well as client's team lead level.
- Good communication skills, both written and verbal.
- Good presentation skills and confident appearance.
- Business fluency in English and the local language (as appropriate).
Team & Environment
This position reports to a Line Manager, Practice Area Lead, or the Head of the Value Delivery Centre Regulatory.
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.
