Regulatory Affairs Specialist

Client of DNA Recruitment

At DNA Recruitment, we carefully review all applications and aim to contact every suitable candidate within 5 working days at the earliest. If you don t hear from us, please consider your application unsuccessful.

Regulatory Affairs Specialist Responsibilities :
• Responsible for the implementation of complex global regulatory strategies, obtaining and maintaining marketing authorizations for products, and communicating general regulatory requirements in support of licensing of the company s products. Serves as a consultant to managers.
• Manage regulatory activities relating to a specific global portfolio of products/projects.
• Responsible for the local implementation of complex global regulatory strategies.
• Obtain and maintain marketing authorizations for product(s) and communication of local regulatory requirements in support of licensing of the company s products.
• Serves as a consultant to managers. Manage regulatory activities relating to a specific portfolio of products/projects.
• 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. Ownership/Life cycle of Regulatory systems, trackers, and databases. Stewardship of the company s position/impact of new/changing regulations, guidance, and standards.)
• Initiate and develop complex regulatory project plans.
• Identify & prioritize key areas of regulatory risk.
• Initiate and develop role-based complex regulatory activities.
• Monitor applicable regulatory requirements.
• Create and maintain regulatory files in a format consistent with requirements.
• Provide regulatory advice to project teams.
• Respond to complex questions from regulatory authorities within strict timelines
• Provide role-based regulatory advice to project teams.
• Coordinate responses to complex questions from cross-functional areas in a timely manner
• Compile and submit, in a timely manner, regulatory documents according to regulatory requirements.
• Maintain and update existing regulatory authorizations.
• Manage regulatory activities relating to a specific portfolio of products/projects.
• Prepare, review, and approve labeling and SOP s.
• Prepare, review, and approve labeling and review AdProm materials for compliance with local regulations.
• Prepare SOPs to reflect specific local requirements.
• Responsible for the update 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.

Regulatory Affairs Specialist Qualifications & Requirements :
• 5 years of regulatory or equivalent experience within a pharmaceutical.
• Knowledge of local regulations & scientific knowledge.
• Fluent Arabic & English.
• Bachelor s degree or country equivalent in a scientific discipline.
• Project management skills.
• Manage multiple projects and deadlines.
• Ability to multitask and prioritize.
• Interpersonal and communication skills with strong negotiation skills.
• Technical system skills (e.g. word processing, spreadsheets, databases, online research).
• Ability to work effectively in multinational & multicultural environments.
• Ability to identify compliance risks and escalate when necessary.
• Stress resistance.
• 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 and be able to work in a rapid-response environment.