ROLE PURPOSE:

• Execute regulatory affairs activities to meet departmental and business goals while ensuring compliance with health authority regulations in assigned markets.
• Ensure alignment with the companys internal procedures for regulatory standards.
• Define, determine, and communicate regulatory requirements and due diligence to stakeholders and project teams.
• Collaborate with cross-functional teams to manage the entire process from concept/development to artwork release for regulatory artwork changes.

REGULATORY & LABELLING RESPONSIBILITIES:Regulatory Documents Submission:

• Compile and submit regulatory documents (new registrations, variations, etc.) according to local requirements.
• Ensure timely follow-up on submissions and manage timely deficiency responses.
• Prioritize high-margin products aligned with business objectives.

Regulatory Tracking:

• Update regulatory trackers with accurate information and provide input for regulatory plans.

Documents Archiving:

• Archive submitted dossiers (soft copies) in shared folders and Veeva RIMs as applicable.

Regulatory Guidelines Support:

• Develop a detailed understanding of regulatory guidelines and technical requirements for assigned countries.

Regulatory Plans Execution:

• Collaborate with the regulatory manager to develop and implement regulatory plans for complex projects (e.g., product transfers, life cycle maintenance, etc).

Renewals Management:

• Manage product and site renewals for the assigned markets by adhering to submission deadlines in the renewal tracker.

Cross Functional Support:

• Provide solutions to a variety of problems of moderate scope of complexity. Interacts with internal and/or external stakeholders. Identifies and responds appropriately to issues, providing adequate solutions.
• Work cross functionally on new products launches and products acquisition. Build better and stronger relationships with relevant internal and external stakeholders

Labelling & Artwork Management (Local/Global IPs):

• AW word files development, annotation and review of the artworks in compliance with local labelling guidelines ensuring quality control English version as well as the Arabic translation to have robust texts.
• Mock-ups creation to support various types of submissions (on Pulse system or with 3rd parties).
• Artwork release post MOH approval and ensures all relevant stakeholders are informed as needed (on Pulse system or with 3rd parties).
• Maintain AW tracker and archives for all the ongoing changes for the artworks.

Compliance:

• Ensure adherence to the companys SOPs and work instructions.

RA Team Support:

• Work on assigned projects to assist other team members where needed based on the business priorities

Regulatory Guidelines Monitoring:

• Monitor changes in the healthcare regulatory environment and communicate updates to relevant stakeholders for implementation.

POSITION REQUIREMENTS:Level of Education required:

• Bachelors degree - In Pharmaceutical Sciences or a relevant life science degree - required
• Masters Degree - Added value
• MOH Pharmacist License - Added value

Years of experience required:

• 2-4 years experience in Regulatory affairs (FMCG/Nutrition/Pharma/consumer)

Technical skills:

• English writing & speaking - Advanced
• Arabic - Added value
• French - Added value
• Good working knowledge of MS Office (Word, Excel & Power Point) - Intermediate to Advanced
• Analytical thinking skills - Good
• Understanding of the local regulations - Very Good
• Time Management - Very Good

Aspen Competencies:BUSINESS:

• Problem solving & Good judgment
• Makes Good Decision

PEOPLE:

• Communicate Effectively
• Dealing with ambiguity/Embrace change

SELF:

• Takes action with Integrity, Contribute Special Expertise
• Continuously grows and develops

Soft Skills:

• Honesty & Ethical Conduct
• Perseverance and tenacity
• Flexibility and tolerance for ambiguity
• Planning and organizational skills
• Empathy
• Responsibility and accountability
• Information seeking
• Writing skills
• Capacity for and resistance to stress
• Active listening skills
• Results Oriented
• Curiosity/learning agility
• Focused
• Initiative taking

Aspen Pharmacare