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Job Title: Regulatory Affairs Executive
Job description
Salary : Negotiable
Duration : 5-6 months ( Could be further extended )
Pre-Requisites :
Bachelor’s Degree in Science
Min 3 Years of experience within the pharmaceutical industry in consumer’s products preferably from a Multinational.
POSITION : Regulatory Affairs Executive
Accountabilities:
- To facilitate the internal and external regulatory compliance of Company’s prescription medicines and CHC products across the region with the objective of smoothly registering / re-registering Organization’s products in compliance with the local legislations.
- Support business in GCC through providing accurate product information in a timely fashion to the different functions, whilst adhering to best practice principles and Company’s standard operational procedures (SOPs).
- Act as a link between the organization and the regulatory authorities, ensuring that products are manufactured and distributed in compliance with appropriate local legislation.
- Closely monitor and update on regulatory environment by ensuring adequate regulatory intelligence communication to internal stakeholders.
- Act in compliance with the internal SOP/LWI/ LSOP and local legislations in the OPU countries.
Product Responsibility
- Product registration
- Acts as a product ‘passport’ enabling function by obtaining local marketing authorisations and appropriate legal approvals.
- Maintains licenses for products and seeks approval for product re-registration on permit / license expiry in accordance with the local legislations.
- Lead all the regulatory activities in all stages of the product lifecycle (for product of concern) including, but not limited to data collection, Artwork creation, corporate submission, product launch (works closely with Marketing and Sales departments), Insert leaflet updates, product variation and ongoing product maintenance.
- Assists in defending product re-registrations, renewals and variations. Resolves product issues with necessary authorities as required (e.g., homeland customs officials for importing products into the respective country)
- Registers new manufacturing sites in the region and participates in the registration process required for a change in manufacturing site location.
Product Information :
- Assists in the Arabic to English and English to Arabic translation ( or any other local language required by the HA ) of product information and checks for translation accuracy in the product packaging and product package inserts
- Drafts product information at product launch, product renewal and product variation in compliance with best practice principles, Organization’s SOPs and local regulations.
- Maintain a compliant product insert leaflet in the country
- Effectively communicate any update in product information to the relevant function
Regulatory compliance
- Maintains regulatory compliance of products with internal and external bodies at the international, regional and local levels. Adapts local requirements and procedures to corporate standards
- Reviews product / legislative updates received from Corporate or local health authorities and ensure that products are compliant.
- Maintains an in-house repository of relevant laws and local authority guidelines. Archives regulatory updates issued by health authorities across the OPU region. Communicates updates to META for their records and assists with special requests from Corporate regarding local / regional regulations.
- Ensures company compliance to regulatory obligations and maintains licenses/authorizations for existing products
- Communicates periodically to the agencies on PSUR and safety data issued by Organization’s Corporate and forwards to the QPPV in the OPU.
- Maintains data integrity of systems and databases (eg. CSC, CPD3) which focus on product launch / change, product crisis management, etc.
- Actively participate in responding for audit, correct findings and clarifying reasons
- Prepares monthly compliance reports and proactively work towards 100 % compliance.
- Take active part in creation of CAPA when needed and support the CAPA actions
Country responsibility
– Support the local RA team with their products of responsibility to feed in the country requirements for their plan, to respond to these needs within the set timelines identified by the team member.
– Prepare and communicate a regulatory intelligence report on any new issued regulation / guideline / circular and to brief the regulatory colleagues.
– Support the local RA team with the local submission and follow up with the local HA for the country of concern.
– Assists in establishing good rapport and effective relationships with Ministries of Health / local health authorities and agents / distributors in the region with focus on countries of concern.
– Ensure in materializing of the submission and approval timelines as planned with the product champion.
– Provides regulatory intelligence for any new regulation, circular or market intelligence.
How to Apply
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