Regulatory Affairs cum Pharmacovigilance OR Quality Management Control Manager

Regulatory Affairs cum Pharmacovigilance OR Quality Management Control Manager

Join to apply for the Regulatory Affairs cum Pharmacovigilance OR Quality Management Control Manager role at PharmaLex.

Overview

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.

Job Details: Cencora Pharmalex is a leading service provider for the pharmaceutical industry globally, specialized in all aspects of drug and medical device approval, market development, and ongoing product maintenance.

Responsibilities

• Regulatory Affairs:
  • Develop and maintain client relationships and explore opportunities for increased service support to Line Manager.
  • Participate in regulatory processes to gain and maintain marketing authorizations for human and veterinary medicinal products, including medical devices, cosmetics, food supplements and herbal products.
  • Prepare, review and compile documents within regulatory affairs projects.
  • Communicate with clients and health authorities; provide scientific advice procedures and represent clients with health authorities.
  • Plan and execute client projects in line with KPIs; coordinate project teams with colleagues and external partners.
  • Provide general consultancy on Regulatory Strategy and Procedure Management.
  • Maintain regulatory intelligence and share knowledge with colleagues.
  • Present seminars and contribute expertise to colleagues, clients and professional audiences.
  • Support Value Delivery Centre strategy implementation and optimization.
  • Ensure compliance and contribute to optimizing internal processes.
  • Support commercial, marketing and business development activities including proposal input; assist in budgeting and reporting.
  • Provide on-site regulatory support to Global Consulting Services clients as agreed with the Head of Value Delivery Centre Regulatory.
  • Take on other reasonable tasks within abilities upon agreement with Line Manager/Practice Area Lead/Head of Value Delivery Centre Regulatory.
  • Pharmacovigilance:
    • Set up and manage the local pharmacovigilance system, including oversight of local PV activities.
    • Local literature search and case safety report collection and management.
    • Pharmacovigilance intelligence screening and local data management.
    • Maintenance of Local Pharmacovigilance System Master File and local data collection.
    • Local PV agreement management and adaptation/submission of periodic safety update reports and risk management plans.
    • Local signal detection and implementation of additional risk minimization measures.
    • Support local post-authorization safety studies and participate in PV audits/inspections.
    • Provide monthly PV status reports and ensure PV training for affiliate employees, service providers and third parties.
    • Collaborate with the global PV system and related local departments.
    • Quality Management Control:
      • Maintain the Quality Management System and conduct Quality Management Reviews.
      • Management of change control, deviations, CAPAs, and supplier/customer qualifications.
      • Conduct internal and external audits and self-inspections.
      • Training and oversight of 3rd party logistics/local distributor activities and labelling.
      • Management of returns, quality complaints and incidents; regulatory intelligence and periodic product reviews.
      • Serve as contact point to local regulatory authorities and ensure local Responsible/Qualified Person where required.
    Education
    • University degree in Life Science.
    Experience
    • Proven experience or demonstrable capability in the area of responsibility or similar field, with advanced knowledge and practical understanding of the service area and related impacts.
    Minimum Skills, Knowledge And Ability Requirements
    • Ability to implement tactical goals of customer or internal projects; prioritize parallel tasks and identify road blocks.
    • Structured, analytical, independent working style with sound judgment on operating policies.
    • Strong problem-solving and pragmatic solution development; high service orientation.
    • Ability to train and support junior colleagues; capable of leading small projects.
    • Skill in managing internal and external relationships at operational and senior levels.
    • Good written and verbal communication; effective presentation skills.
    • English business fluent and local language proficiency as appropriate.
    What Cencora offers

Benefit offerings outside the US may vary by country and will be aligned to local market practice. Eligibility and effective dates may differ for some benefits and for team members covered under collective bargaining agreements.

Affiliated Companies

Affiliated Companies: PharmaLex Australia

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. 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. If you wish to request an accommodation, please contact or call .

Seniority level

• Mid-Senior level

Employment type

• Full-time

Job function

• Quality Assurance

Industries

• Pharmaceutical Manufacturing

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