Main Responsibilities:
Manage Regulatory Affairs for AbbVie Egypt.
Advance Pipeline/Marketed Product Support: Submissions, Renewals & Approvals:
- Ensure that all regulatory submissions (New marketing authorization applications, renewals, variations, notifications) are prepared and filed in timely manner for company products.
- Follow up all steps for Authorization/approval of these submissions.
- Gain Regulatory Authority approval for marketing authorizations for new products.
- Maintain all existing product marketing authorizations and gain Regulatory authority approval of variations to these authorizations as required.
- Manage any further information requests from local Regulatory authority in a timely manner, submission of any subsequent responses/product documentation updates to local Regulatory authority.
- Review product information in accordance with legal and regulatory requirements; ensure that all prescribing information is accurate, update and approved by both company and relevant Regulatory authority in accordance with company policies and local regulations.
- Responsible for updating the Regulatory database.
Regulatory Excellence:
- Represent AbbVie in the relevant pharmaceutical trade associations and liaise with external stakeholder.
- Establish and maintain good relationship with all involved regulatory institutions in Egypt.
- Coordinate and ensure effectiveness of Regulatory Affairs function.
- Support NPI/Launch Excellence process in Egypt.
- Support PPLS process in Egypt.
Assist with training of AFFILIATE staff on relevant Regulatory processes
General Responsibility:
- To comply with the company’s policies and procedures to meet statutory, quality and business requirements within the overall strategy and objectives of AbbVie.
Background:
- Strong communication and negotiating skills.
- Excellent teamwork skills.
- Good knowledge of local registration requirements.
- Fluency in English both verbal and written.
- Efficient computer skills.
- 2-5 years’ experience in regulatory affairs in Egypt
- 1-2 years’ experience in multinational company is a plus
Education:
- University degree Bachelor of pharmacy , vet medicine, dentist or medicine .
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