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

Labelling responsibilities:

• 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.

Promotional material responsibilities:

• Validating Promotional materials, Abbreviated prescribing information

EDUCATION QUALIFICATIONS AND EXPERIENCE:

• Bachelor Degree in Pharmaceutical Science
• Master\'s Degree advantageous
• 3-4 years\xe2\x80\x99 experience Regulatory affairs (FMCG/Nutrition/Pharma/consumer)

TECHNICAL SKILLS:

• English /Arabic /French - Very good/Fluent
• French is a must
• Good working knowledge of MS Office (Word, Excel & PowerPoint) - Intermediate to advanced
• Analytical thinking skills - Good
• Understanding of the regulations - Very Good
• Time Management - Very Good

KEY ATTRIBUTES:

BUSINESS

• 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

PEOPLE

• Perseverance and tenacity
• Communicate effectively

SELF

• Takes Action with Integrity
• Continuously grows and develops

Internal Applicants must inform their direct line managers of their application. Applications must be completed using an Aspen email address.
If you have not heard from the HR department within 30 days of this advert closing, please consider your application unsuccessful.

Aspen Pharmacare