Regulatory Affairs Manager - KSA

Educational Requirement:

Bachelor's 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 Takeda’s product applications, variations, post approval reporting obligations and general product life cycle management support for Saudi Arabia.

Ensure that Takeda’s 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.