Regulatory Affairs and Labelling Associate
3 weeks ago
**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 company’s 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 company’s 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:
- Bachelor’s degree - In Pharmaceutical Sciences or a relevant life science degree - required
- Master’s 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
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