Snr Specialist Regulatory Affairs at MSD

Job Description
Basic Functions & Responsibility (may not be limited to)

• For assigned products, ensures timely preparation, submission, and appropriate follow-up of new Marketing Authorization applications to authorities in the SSA markets.
• Ensures maintenance of assigned, authorized products through timely submission of variations, renewal applications, and supplemental marketing authorizations.
• For assigned products ensures timely, accurate and compliant labelling translations and artwork preparation.
• For assigned products and tasks, stays updated on late our companypipeline filings, relevant regional and local regulations and guidelines and to develop and maintain positive relationship with key players in the regulatory environment. Designs and implements regulatory ad-hoc local action plans, as necessary.
• Collects relevant publicly available regulatory information (regulatory intelligence) and keeps relevant persons appropriately informed.
• Maintains a positive relationship with internal and external regulatory contacts. External contacts are regulatory authorities, as well as other key players in the regulatory environment.
• By discretion of Regulatory Affairs Management and due to organization and workload, all listed activities need not to be performed.
• Applicable to incumbent with direct reports only Responsible for people management of applicable Regulatory personnel in SSA and provides clear leadership for these. Secures appropriate career development for the applicable staff and is responsible for keeping the applicable staff scientifically and legally updated within the Regulatory area.

Labelling and artwork

• Ensures high quality translations and QRD check of Summary of Product Characteristics and Patient Package Leaflets including linguistic check of these documents.
• Ensures availability of packaging material, including package leaflets and all other artwork in a timely and correct manner and according to relevant Artwork Management procedures.

Regulatory policy & environment

• Keeps abreast of local and international laws, collects relevant publicly available regulatory information, provides insights and responds to consultations on proposed national regulatory guidance, as appropriate, and communicates final regulatory guidance for awareness and impact assessment, in cooperation with Global Regulatory Policy.
• Shapes the regulatory environment through liaising with the local agency, local pharmaceutical organization, and other stakeholders, and in concurrence with the Regulatory Policy lead.

Qualifications, Skills & Experience

• Must be hold a degree in pharmacy or other life science or equivalent.
• A minimum of 4 years’ experience in a Registration Department or equivalent, which should include dealing directly with regulatory Agencies.
• The incumbent must be familiar with local legislation procedures and guidelines governing pharmaceutical products.
• demonstration of proficiency in local and English language as well as PC use with regard to word-processing, spreadsheets, database application, and internet.
• Must have client-oriented approach and work according to our company leadership vision.