Senior Regulatory Affairs Pharmacist/Associate

At Roche you can show up as yourself, embraced for the unique qualities you bring.

Our culture encourages personal expression, open dialogue, and genuine connections,  where you are valued, accepted and respected for who you are, allowing you to thrive both personally and professionally.

This is how we aim to prevent, stop and cure diseases and ensure everyone has access to healthcare today and for generations to come.

Join Roche, where every voice matters.

The Position

A healthier future.

It’s what drives us to innovate.

To continuously advance science and ensure everyone has access to the healthcare they need today and for generations to come.

Creating a world where we all have more time with the people we love.

That’s what makes us Roche. 
 

The Opportunity

Roche Pharma is seeking a Senior Regulatory Affairs Pharmacist/Associate to join their team in Johannesburg.

Your primary responsibility is to secure the registration of medicines, obtain approval for new product indications in alignment with the business strategy, and maintain current product dossiers.

Key Challenges

Strategic Planning:


* Advising on the most suitable time for submitting dossiers/new indications according to Roche Global timeframes and ensuring registration/ approval by the health authority in the shortest possible time.


* Coordinate, monitor and supervise timeous submission and maintenance of dossiers in accordance with corporate and local directives, guidelines, SOP’s and legislative requirements.


* Gather, analyse and communicate internal and external regulatory intelligence.


* Provide regulatory expertise and input into cross-functional Affiliate business strategies (e.g.

market access, medical affairs, promotional activities, public policy, technical assessments, technical agreements, local manufacturing/packaging activities, legal issues, etc.)


* Develop innovative, risk-based registration plans and submission strategies for Affiliate products with limited guidance from DRA Management.

Operational:


* To monitor that Roche Pharma complies with all aspects of local legislation relating to medicines and pharmacy practice as well as other internal guidelines, directives and SOP’s, identify anomalies and implement corrective action.


* Review and prioritize the product registration portfolio and align it with the business needs and objectives, in line with market trends and developments.


* Compile dossiers and submit in accordance with corporate, legislative and health authority requirements and are executed timeously.


* Manage complex or larger scale products to support, take a lead on special projects, and help on-board and train DRA colleagues.


* Assist the Product Teams with the approval of advertising materials and reviewing and aligning with the legal advertising requirements

Stakeholder Management:


* Provide advice and guidance to relevant Roche departments regarding local medicine, ph...