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Regulatory Affairs Specialist 2017-Mar-21

Cairo , EGYPT | Marketing
Job type:

Full time

Experience :

3 -5 years

Job description :

Duties include:
 Directs personnel in the preparation of regulatory submissions across the MENA region.
 Reviews products’ submissions for quality and completeness
 Prepares and/or reviews product labeling, product monographs, and marketing materials as required
 Liaise with Local Health Authorities’ personnel, global and regional teams, internal and external organizations such as suppliers
 Provides interpretation on complex regulatory guidelines and policies
 Manages outside consultants, including legal counsel, patent agents, and regulatory consultants on any matter required
 Work with product development teams to ensure domestic and international regulatory requirements are incorporated as part of the development process
 Assist in post-market submissions
 Support marketing, R&D and manufacturing teams in regulatory assessment of proposed changes or product transfers
 Communicate any regulatory correspondence on submissions to the appropriate teams and RA management
 Conduct regulatory reviews, compliance gap analyses, implementation planning, and project management to ensure compliance with applicable regulatory requirements
 Assist the Manager and others with the development, implementation and maintenance of regulatory SOPs
 Assist Head of Medical Safety in responding to requests for safety information from regulatory authorities or third-parties related to MENA region
 Inform Head of Medical Safety of new developments (major changes in regulations, new guidelines) in medical/drug information and safety fields
QUALIFICATIONS
 Minimum Bachelor’s degree in Life Sciences is required
 Minimum of 3-5 years experience in regulatory affairs in Egypt and/or other countries in the MENA region, with at least 2 years of management experience leading teams/people/projects
 Detailed knowledge of regulatory requirements, policies and guidelines
 Intermediate computer skills required including MS Word, Excel, PowerPoint
 Strong leadership and time management skills
 Strong interpersonal skills (written and verbal) are required
 Strong analytical and problem solving skills

Candidate information:

Gender :

Any

Age :

26 -35 years

Skills required :

--

Languages :

English | Very good

Benefits & allowances:

Salary:

Negotiable

Allowances :

Others

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