CW-Sr Associate Regulatory Affairs Maghreb

Career CategoryRegulatory

Job Description

Key responsibilities:

Planification, preparation, submission to HA and, follow up of the RTQ and the approvals of the variations, renewal and new application dossiers

Review and dispatch variation, new application and renewal dossier to distributors and ensure submission

Knowledge of the registration process and local regulations

Responsible of file publishing to regional distributor

Follow up submission and approvals with distributors (Morocco and Tunisia)

Dispatch LOQ from regional HA to global teams and follow up on RTQ, dispatch RTQ once provided to distributor and ensure submission and approvals.

Carrying the planned LCM activities and reflecting the approvals on the internal systems

Interact with Health authorities / Represent Amgen. (Algeria)

Provides guidance for regulatory requirements of variations (CMC, Labelling, admin…)

Responsible for review and validation of promotional and non-promotional material, declaration of PM and non PM to Health authorities, and follow up to get approvals. (Algeria, Morocco and Tunisia), (Promotional material Lead)

Responsible for training staff on promotional and non-promotional material SOP

Provides guidance for regulatory requirements of new application requirements

Provide support and regulatory guidance to cross functional department

Accountable for documenting variations (CMC, Labelling, administrative…) submissions and related communications; archiving documents in document management systems

Interacts with RRL, Intercontinental CMC teams to ensure the filling of regulatory requirements per country for variations and renewal

Responsible to review local labelling to compile with local requirements

May participate in cross-functional special project teams.

Provide country product & regulatory expertise, oversight & guidance;

Involved in redacting SOP when relevant

Regulatory intelligence updates;

Advocates and actively supports regulatory/safety compliance

Decisions on implementation of regional CMC strategic objectives

Ensure safety back up

Qualifications

Pharmacist/ Pharm D pharmacy

A minimum of 2 years related experience in pharmaceutical/biotechnology, Regulatory Affairs in multinational industry.

Professional Knowledge and skills

Confidentiality and accountability.

Negotiation & communication skills

Organization skills and high accuracy in documentation

High sense of urgency

Priority setting and management

Multitasker

Analytical skills

Ability to alert hierarchy in case of specific situation impacting his/her work environment

Problem solving skills and sense of anticipation

Presentation skills

Interpersonal skills

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R-199790