Drug Regulatory Associate & Quality Manager (Cameroon), Associé Réglementaire Médicament & Responsable Qualité (Cameroun), Roche
Role Responsibilities/ Responsabilités du rôle
To supervise the affiliate’s regulatory and quality area of activities and relations with relevant third parties (health authorities etc).
Ensure timely registration and maintaining of marketing authorization of Roche products in Cameroon in order to expand the product range as fast as possible.
Support in overseeing warehouse and distribution partners within the subregion regarding implementation, utilization and continual improvement of a quality system, in order to ensure compliance with local regulations and applicable Roche PQS requirements as well as an uninterrupted supply of quality products to the patients.
Key Responsibilities related to Quality Manager role:
- Warehousing and distribution partners:
Support selection of new partners by active assessment support during the due-diligence phase (paper-based and/or onsite).
Oversee closing of gaps and adherence to long-term GxP-Compliance Plans.
Act as first-level support for warehousing and distribution partners concerning quality-related topics (except temperature excursions, complaints and issues which have to be handled directly via the respective.communication channels).
Oversee implementation, utilization and continual improvement of the quality system at the 3rd party during the manage phase.
Execute trainings with individual partners based on their specific needs.
- Pharmacies, Hospitals and other involved Service Providers:
Realize training needs and execute accordingly.
Support in preparation and facilitation of regional workshops.
Monitor health authority trends and discussions for the countries within the region.
Support Global Quality Manager in data collection and interpretation for the QMR’s.
Key Responsibilities related to Drug Regulatory Associate role:
As assigned, gather, analyse and communicate internal and external regulatory intelligence.
Provide regulatory expertise and input into cross-functional Affiliate business strategies (e.g. market access, medical affairs, promotional activities, public policy, technical assessments, technical agreements, local manufacturing/packaging activities, legal issues, etc.).
Develop innovative, risk-based registration plans and submissions strategies for Affiliate products with guidance from Drug Regulatory Affairs Management.
As assigned, represent Affiliate Regulatory in cross-functional teams.
Adapt global product dossiers to local requirements.
Prepare and manage regulatory registration filings across product lifecycles.
Monitor and communicate all regulatory filings status and respond to internal and external questions, or other needs.
Ensure timely regulatory filings submissions and approvals.
Influence internal and external stakeholders for successful regulatory outcomes.
- Regulatory Compliance:
Develop and maintain current knowledge of international and local regulations and other governing regulatory practices, policies, procedures, processes, systems and standards.
Ensure regulatory inspection-readiness for the Affiliate, as per assigned responsibilities.
Ensure regulatory compliance for product released to market according to marketing authorities.
4.Information and Documentation Management:
Manage Affiliate regulatory activities on relevant Roche systems.
Manage end-to-end local product packaging and labelling from a regulatory perspective.
Where applicable, review and approve promotional materials to provide regulatory input and guidance across the Affiliate.
Where applicable, provide regulatory administrative support for local lot releases.
Support local market access activities from a regulatory perspective.
University degree in one of the following or related scientific disciplines: pharmacy, medicine, veterinary medicine, pharmaceutical chemistry and technology, or biology.
Significant experience Regulatory affairs.
At least 2-year experience in a pharmaceutical manufacturing facility in the areas of Quality Control and/or Quality Assurance or at least two years of experience in the pharmaceutical environment of an affiliate, direct market country or sub-regional center dealing with warehousing and distribution partners.
Sound knowledge of international, regional and local regulations relating to GMP and GSDP.
Basic knowledge in pharmaceutical packaging/redressing operations.
Experience in Medical function (Clinical Research, Medical Information etc.) of a pharmaceutical company preferred.
Sound knowledge of Roche’s Pharmaceutical Quality System (PQS) and all related processes.
Knowledge in temperature controlled supply chain.
Practical experience in qualification of warehouses and shipping systems.
Sound knowledge of Roche’s Pharmaceutical Quality System (PQS) and all related processes
Additional Requirements – Skills, Behaviors, and Attributes:
Excellent written and oral communication skills.
Analytical and problem solving skills.
High degree of proficiency in the local language and in English.
Leadership and management skills.
Organization and planning skills.
Proven ability to interact well in a multifunctional team setting.
Knowledge of the local regulations & regulatory Aauthorities.
Who we are
At Roche, 100,000 people across 100 countries are pushing back the frontiers of healthcare. Working together, we’ve become one of the world’s leading research-focused healthcare groups. Our success is built on innovation, curiosity and diversity.
Roche is an equal opportunity employer.
Location Cameroon, Cameroon Function Regulatory Affairs Subfunction Affiliate Regulatory Affairs Schedule Full time Job level Individual contributor Job type Regular Division Roche Pharmaceuticals Posted since 2021/12/01 Posted until 2021/12/17 Job-ID 202110-128589
Postuler (Apply for the job) sur son site Internet: https://www.roche.com/careers/jobs/jobsearch/job.htm?id=E-202110-128589&locale=en&title=Drug+Regulatory+Associate+%26+Quality+Manager+%28Cameroon%29
The Weekly Job Report, Le rapport de travail hebdomadaire, 29/11/2021: https://afriquejobs.com/2021/11/28/the-weekly-job-report-le-rapport-de-travail-hebdomadaire-29-11-2021/
All companies hiring (Entreprises qui emploi au Cameroun): https://www.afriquejobs.com/2020/07/emplois-jobs-au-cameroun-liste-des.html
More jobs (Plus d\’offres d\’emploi): https://www.afriquejobs.com/