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Description
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.
Requirements
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
Work Level
Skilled
Job Type
Temp
Salary
Market Related
Duration
1 - 2 Years
EE Position
No
Location
Dubai
DETAILS TO REGISTER FOR THIS JOB:
NOTE: ATS-friendly CV is COMPULSORY!
https://aspen.mcidirecthire.com/External/Job?Ref=TEkBhDYErs0qhHgueWeCgt_yRI-cnPLR1MRk1RR6CprFrXLdxUBmuvDnnTmdoKy7zR1U9dBNqS9SSejPy208FJxFYPKqPn1OjgCoZNp1c3CO-u6YTvfO7ITuiKRj2uLjZvUsp7Gk7qjCiIkImYWV9QNOTE: ATS-friendly CV is COMPULSORY!
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