Regulatory Affairs Associate Menat (temp 1 Year Contract)
Dubai, United Arab Emirates
Job Description
Description
ROLE PURPOSE:
Regulatory Documents Submission:
POSITION REQUIREMENTS:
Level of Education required:
At Aspen, our culture is built on core values that drive our success and foster a supportive, innovative environment. We value Teamwork, where diverse perspectives and skills come together to enhance creativity and problem-solving. Innovation is at our core, as we continually seek better ways to achieve our goals and remain at the forefront of our industry. We demonstrate Commitment by exceeding expectations and building long-term relationships, while always striving for Excellence in everything we do. Our foundation of Integrity ensures that honesty, ethical behavior, and accountability guide our decisions. By proceeding with this job application, we understand that you share these values, and we look forward to reviewing your application and engaging with you further.
Aspen Competencies:
BUSINESS:
Skilled
Type
Temp
Salary
Market Related
Duration
1 - 2 Years
EE Position
No
Location
Dubai
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 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.
- Update regulatory trackers with accurate information and provide input for regulatory plans.
- Archive submitted dossiers (soft copies) in shared folders and Veeva RIMs as applicable.
- Develop a detailed understanding of regulatory guidelines and technical requirements for assigned countries.
- Collaborate with the regulatory manager to develop and implement regulatory plans for complex projects (e.g., product transfers, life cycle maintenance, etc).
- Manage product and site renewals for the assigned markets by adhering to submission deadlines in the renewal tracker.
- 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.
- Tender support with necessary information (as needed).
- 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 the AW system or with 3rd parties).
- Artwork release post MOH approval and ensures all relevant stakeholders are informed as needed (on the AW system or with 3rd parties).
- Maintain AW tracker and archives for all the ongoing changes for the artworks.
- Abbreviated Product Information (API) review as needed.
- Ensure adherence to the companys SOPs and work instructions.
- Work on assigned projects to assist other team members where needed based on the business priorities
- 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
- 3-4 years experience in Regulatory affairs (FMCG/Nutrition/Pharma/consumer)
- English writing & speaking - Advanced
- Arabic - Advanced
- 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
At Aspen, our culture is built on core values that drive our success and foster a supportive, innovative environment. We value Teamwork, where diverse perspectives and skills come together to enhance creativity and problem-solving. Innovation is at our core, as we continually seek better ways to achieve our goals and remain at the forefront of our industry. We demonstrate Commitment by exceeding expectations and building long-term relationships, while always striving for Excellence in everything we do. Our foundation of Integrity ensures that honesty, ethical behavior, and accountability guide our decisions. By proceeding with this job application, we understand that you share these values, and we look forward to reviewing your application and engaging with you further.
Aspen Competencies:
BUSINESS:
- Problem solving & Good judgment
- Makes Good Decision
- Communicate Effectively
- Dealing with ambiguity/Embrace change
- Takes action with Integrity, Contribute Special Expertise
- Continuously grows and develops
- Honesty & Ethical Conduct
- Perseverance and tenacity
- Problem solving & Good judgment
- 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
Skilled
Type
Temp
Salary
Market Related
Duration
1 - 2 Years
EE Position
No
Location
Dubai
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Job Detail
-
Job IdJD1893413
-
IndustryNot mentioned
-
Total Positions1
-
Job Type:Full Time
-
Salary:Not mentioned
-
Employment StatusPermanent
-
Job LocationDubai, United Arab Emirates
-
EducationNot mentioned