Job Description

Roles & Responsibilities

CORE JOB RESPONSIBILITIES

Work with Regional RA Manager to implement regulatory strategies on the short, medium and long term by adding new products to our portfolio and maintaining existing ones.

Work with business development and Marketing to set appropriate regulatory strategies on the short, medium and long term by adding new products to our portfolio.
Prepare regulatory plans and ensure their implementation to achieve long term objectives for products that can be qualified in term of sales, market share and profit contribution goals.
As area label coordinator, work closely with different manufacturing sources QA and label development to get labels developed, approved and implemented as per the time frame agreed with management.
Work closely with logistics department to organize timely sample delivery
Prepare regulatory dossiers for new product, renewal and variation dossiers preparation
Work closely with the marketing and medical department to review and approve the promotional materials per the agreed guidelines & within the required timeframe.
Work with GPRA for new products, renewal and variation dossiers preparation
Maintain effective communication with the local representatives and MOH officials
Submission of regulatory file in Tunisia and interactions with HA

Compliance

Accountable for compliance with Regulatory SOPs and identification of improvement opportunities for SOPs.
Ensure compliance with Corporate and Divisional Standard Operating Procedures SOPs, Good Clinical Practice, and local regulatory requirements pertaining to the conduct of clinical studies.
Relay Abbott Corporate values train new recruits

Quality

Ensure compliance with quality SOPs and regulatory requirements in the area of responsibility.
Ensure Training is completed as Planned.

Key Success Factors:

Registering & life cycle management- registration of new products and managing existing portfolio within changing & challenging regulatory environment.
Business Support-liaises proactively with the functions and participate as a member of cross-functional delivery teams,providing regulatoty advice on simple regulatory issues
Systems and procedures-Ensure appropriate archiving of regulatory dossiers, documents as per global and local procedure.
Submission to Has of promotional and non-promotional activities/symposia/congresses.
Ensure close follow-up and effective implementation of regulatory compliance procedures.

QUALIFICATIONS

Pharmacy Degree

Experience:

Minimum 3 years of relevant experience.
Solid pharmaceutical experience, including significant regulatory Affairs
Experience multi-national exposure Fluent French language, in addition to English. Arabic a plus.

Regulatory Affairs Specialist Abbott Laboratories

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