Senior Regulatory Affairs Specialist
Posted on :
25-03-2024
Employer Active
1 Vacancy
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Job Description
Req ID : 2659179
- Forecast & plan annual submissions according to business priorities and in collaboration with marketing and commercial colleagues.
- Responsible for product lifecycle management of the portfolio under scope of responsibility by planning and coordinating requirements for compiling submission dossiers for all types of regulatory activities according to each country rules and regulations including new products registration, re-registration, listing, changes and custom clearance.
- Ensure timely submission, follow up and approval of submitted registration/market authorization applications through collaboration and communication with distributors in local markets ensuring timely launch of NPI’s and NPD’s and full regulatory compliance of registered products at all times, ensuring compliant business continuity.
- Effectively communicate and collaborate cross functions with internal stakeholders including sales and marketing teams to understand business priorities, support and provide regulatory documents to support tender requests, understand and communicate accurately regulatory requirements to global regulatory affairs teams.
- Build a strong relationship with external stakeholders including distributors in the countries by conducting follow up meetings to ensure continuous progress of opened applications and obtaining timely approvals, as needed provide training and knowledge on internal processes, products and common documentation.
- Conduct FSCA, FSN and complaints reporting activities according to each country’s regulations.
- When necessary, conduct copy review of marketing materials and submit for Health Authority approval in countries where it is applicable.
- Maintain all internal databases up to date as per internal SoP’s.
- Is able to anticipate and flag risks to relevant stakeholders, when necessary, along with providing proposed solutions and action plan.
Employment Type
Full Time
Department / Functional Area
Key Skills
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