Regulatory Associate at Roche

Reporting to the Regulatory Manager Roche Products, your role will be instrumental in supporting the Regulatory Manager in the implementation of planned regulatory strategy as it pertains to new plans for product registration and registered products that are available in the market. You will closely collaborate with internal and external stakeholders to ensure Roche product portfolios are timely approved by regulatory authorities and that Medical and healthcare compliance requirements are met and processes are productive. In addition, you will be responsible for:

• Ensuring the availability of products by implementing required Regulatory process in the product shipment chain
• Maintaining a good relationship with key stakeholders involved in product shipment
• Supporting Regulatory unit in the implementation of agreed regulatory strategy as it relates to product registration, document submission, and system tracking.
• Managing relationship with key stakeholders at the Regulatory Authority’s office (NAFDAC)
• Ensuring periodic submissions are implemented to Regulator’s timelines and internal global system trackers are maintained according to SOPs
• Submitting dossiers in accordance with health authority requirements and are executed timeously
• Ensuring proper filling and archiving of all relevant Roche documents both physical storage and electronic storage on Touchpoint
• Assisting with assembly, distribution, storage, tracking and retrieval of information pertinent to regulatory process

Who you are
You’re someone who wants to influence your own development. You’re looking for a company where you have the opportunity to pursue your interests across functions and geographies. Where a job title is not considered the final definition of who you are, but the starting point.

Successful candidates will meet the following requirements:

• University degree in pharmacy  (Bachelor of Pharmacy) and preferable work experience in regulatory function
• Knowledge of the Nigerian Regulatory landscape.
• Experience of managing complex issues in a matrix organization
• Strong quality and compliance orientation
• Fluent in written and spoken English