Regulatory Affairs Manager KSA

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Educational Requirement:

Bachelors degree in pharmacy field from a renowned institution / university

Relevant Experience & knowledge:

• At least 5 years of experience in Regulatory Affairs field.
• 3 years of solid Regulatory Affairs experience in a medium to large size reputable organizations.
• Excellent in-depth knowledge in different Regulatory Pathways for SFDA.
• In-depth understanding of pharmaceutical industry within the country.
• Good knowledge of key business functions such as business development market access Medical etc.
• Must be able to work in a fast-paced environment with demonstrated ability to deal with competing tasks and demands.
• Excellent verbal and written communication skills.

Job Function and Description:

• In collaboration with International RA Strategists provide regulatory strategies to responsible functional groups and regulatory management.
• Prepare and submit Takedasproduct applications variations post approval reporting obligations and general product life cycle management support for Saudi Arabia.
• Ensure that Takedas products comply with the registration of health authorities in Saudi Arabia.
• Ensure appropriate evaluation of local business and regulatory registration requirements for investigational and marketed products and prepare regulatory assessment reports as needed.

• Provide guidance/advice on international regulatory environments provide assessment of the impact of new and changing regulations/requirements.

• Develop effective working relationships with business partners and service providers in the Saudi Arabia including local visits as needed.

• Updates Takeda with the most recent registration requirements and procedures for manufacturers and products.

• Receives the registration files and makes the final check before uploading on SFDA platform or forwarding to the local distributor for submission to the authorities.

• Places the orders for buying chemicals and / or HPLC columns requested by the SFDA Laboratory.
• Negotiate with the SFDA for product pricing on behalf of Takeda
• Receives the final registration certificate of the product and / or manufacturing site.
• Sends copy of the registration certificate and archives the original in the LOC.
• Keeps records of all registration certificates and notifies IRA and local distributor six months before expiry so as to initiate the renewal process.