Regulatory Affairs Associate North Africa Dubai
Dubai, United Arab Emirates
Job Description
ROLE PURPOSE: Execution of regulatory and compliance tasks to help achieve departmental and business objectives while ensuring compliant operation within the flexibility of the regulations. Successfully execute regulatory affairs and compliance activities for company product lines. Determine, define and communicate regulatory requirements to commercial, project teams and other stakeholders as relevant. RESPONSIBILITIES: Regulatory responsibilities are- but not limited to-:
- Compile and submit, in a timely manner, regulatory documents according to regulatory requirements. Regular follow up on the submitted files.
- Ensure timely submissions as well tightly manage deficiency responses. Priority will be given to the positive margin products.
- Feed the trackers provided by APTL/ group/ AGI with accurate information and provide them with input for any regulatory plan rolled out
- Work with the regulatory affairs manager to develop a detailed understanding of regulatory guidelines and technical requirements in assigned countries
- Work with the regulatory affairs manager to develop and execute regulatory plans for complex projects including transfer of the newly acquired products, tech transfers and maintenance of licenses/authorizations for existing marketing authorizations
- Work on Renewals (products and sites) submit the request as per the date mentioned in the renewal tracker. Renewal planned submission date should be met.
- Provides 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.
- Act as a link between the global organization and the regulatory authorities, ensuring that products are manufactured and distributed in compliance with appropriate local legislation
- Work cross functionally on new products launches and products acquisition. Build better and stronger relationships with relevant internal and external stakeholders
- Act in compliance with the internal SOP and ways of working
- Ensure a proper archiving for any submitted dossier (soft copy) in line with the company SOPs
- Update the internal trackers
- Work on assigned projects to assist other affiliate where needed based on the business priority
- Identify changes and modifications in the healthcare regulatory environment; and communicate those changes to appropriate individuals and departments for implementing into the organization\xe2\x80\x99s processes.
- Assigned markets: North Africa
- Annotation and review of the artworks in compliance with local labelling guidelines and COO approved text. Review of text translation from French to Arabic.
- Artwork release when any approval is received and ensures all relevant stakeholders are informed.
- Validating Promotional materials, Abbreviated prescribing information
EDUCATION QUALIFICATION AND EDUCATION:
Problem solving & Good judgment
Information Seeking
Responsibility and accountability
Focused
Planning and organizational skills
Results Oriented
Initiative PEOPLE
Capacity for and resistance to stress
Perseverance and tenacity
Flexibility and tolerance for ambiguity
Transition management
Meeting facilitation
Writing skills
Empathy SELF
Honesty
Ethical Conduct
Self-assurance
Personal responsibility
Self-awareness
Curiosity/Learning agility ASPEN COMPETENCIES: BUSINESS
- Bachelor Degree - In Pharmaceutical Science
- Master\xe2\x80\x99s Degree - Advantageous
- 3-4 years\xe2\x80\x99 experience Regulatory affairs (FMCG/Nutrition/Pharma/consumer)
- English /Arabic /French - Very good/Fluent
- French is a must
- Good working knowledge of MS Office (Word, Excel & Power Point) - Intermediate to advanced
- Analytical thinking skills - Good
- Understanding of the regulations - Very Good
- Time Management - Very Good
Problem solving & Good judgment
Information Seeking
Responsibility and accountability
Focused
Planning and organizational skills
Results Oriented
Initiative PEOPLE
Capacity for and resistance to stress
Perseverance and tenacity
Flexibility and tolerance for ambiguity
Transition management
Meeting facilitation
Writing skills
Empathy SELF
Honesty
Ethical Conduct
Self-assurance
Personal responsibility
Self-awareness
Curiosity/Learning agility ASPEN COMPETENCIES: BUSINESS
- Problem-solving & Good judgment
- Makes Good Decision
- Perseverance and tenacity
- Communicate effectively
- Takes Action with Integrity
- Continuously grows and develops
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Job Detail
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Job IdJD1533124
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IndustryNot mentioned
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Total Positions1
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Job Type:Full Time
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Salary:Not mentioned
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Employment StatusPermanent
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Job LocationDubai, United Arab Emirates
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EducationNot mentioned