We are currently looking for a motivated and well-spoken Regulatory Affairs Specialist.

The ideal candidate will be responsible for RA preparation, submission, follow-up, and approval of new registrations, renewals, and maintenance activities.  To be successful in this role the candidate needs to comply with the company’s standards under the umbrella of the local health authority regulations. The candidate should be skilled to handle local commercial and function needs, as well as, work hand in hand with later teams.

Senior Regulatory Affairs Specialist will be based in Marocco.

At DNA Recruitment, we carefully review all applications and aim to contact every suitable candidate within max. 5 working days. If you don’t hear from us, please consider your application unsuccessful on this occasion.

 Responsibilities

• Set a proper RA strategy for Morocco and Tunisia based on global & local business priorities.
• Accelerating and planning new registrations
• Strong lobbying with local distributors in Morocco and very well-connected with Tunisia authorities
• Leads an up-to-date RA status for already registered products through timely submission of renewals and life cycle maintenance updates
• Leads Regulatory intelligence:  Make sure all relevant stakeholders are updated on the latest regulations  
• Understands all aspects and phases of role-based activities (e.g.: the submission process across the product lifecycle continuum, including management of submission content/format to ensure high-quality submissions that facilitate review/approval by Regulatory Authorities.  
• Identify & prioritize key areas of regulatory risk
• Initiate and develop role-based complex regulatory activities
• Coordinate responses to complex questions from cross-functional areas on time
• Provide guidance to Compile and submit, on time, regulatory documents according to regulatory requirements
• Guide to prepare, review, and approve labeling and review materials for compliance with local regulations
• Prepare SOPs to reflect specific local requirements.
• Responsible for updating and maintenance of role-based activities.
• Lead or represent Regulatory Affairs in project teams
• Provide guidance and coaching for areas of responsibility to lower-level team members

Qualifications

• 5 years of experience in Regulatory Affairs
• Languages: English and French
• Knowledge of regulations
• Scientific knowledge
• Projectmanagement skills
• Manage multiple projects and deadlines
• Ability to multitask and prioritize
• Interpersonal and communication skills
• Strong negotiation skills
• Technical system skills (e.g. word processing, spreadsheets, databases, online research)
• Ability to work effectively in a multinational/multicultural environment
• Ability to identify compliance risks and escalate when necessary
• Bachelor or country equivalent in a scientific discipline
• Stress resistance
• Excellent communication skills, both verbal and written.
• Good organizational skills and the ability to multitask.
• Strong listening skills.
• Ability to provide regular weekly updates on progress and explain the progress.
• Strong team player, with a flexible approach yet able to work unsupervised and under pressure
• Self-motivated with a high level of initiative
• Excellent communication skills be able to work in a rapid-response environment

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