Regulatory Affairs Partner

Job Description

We are Roche

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.

Summary

The Regulatory Affairs Partner role is a temporary one-year assignment primarily responsible for managing regulatory activities to ensure optimal registration of new products and indications and ongoing compliance with regulations. This role will work closely with health authorities in Iran and ensure full compliance with Roche's regulatory policies and governing legislation.

The Regulatory Affairs Partner reports to the Medical & LTO Enabler.

You will be responsible for:

- Act as the primary point of contact for the Iranian Food and Drug Administration (IFDA) regarding all GxP activities for chemical products.
- Oversee the review, approval, and submission of local marketing authorizations (MAs), IDL forms, license renewals, and post-approval changes.
- Support regulatory inspection-readiness for the affiliate by leading or participating in both internal and external audits.
- Provide regulatory expertise for cross-functional business strategies, such as market access and promotional activities, and collaborate on packaging and artwork management.
- Maintain and communicate key regulatory progress, outcomes, and risks to stakeholders while fostering relationships with internal partners, customers, and health authorities.

Compliance

You are expected to adhere through your conduct to all applicable laws and regulations as well as to the high integrity standards as set forth by Roche.


Who You Are

- You hold a university degree in PharmD. An additional degree in Life Science or an MBA being an advantage.
- You have a minimum of 3+ years of regulatory experience within the pharmaceutical industry in the country.
- You have Familiarity with the code of conduct, pharmaceutical regulations, and the overall drug development process relevant to pharmaceutical/biotechnology organizations.
- You have Previous experience working with health authorities and relevant governmental departments.
- Advanced knowledge of the Microsoft Office suite (Word, Excel, PowerPoint & Outlook), strong presentation skills, and fluency in both English and Farsi (written and verbal).
- You are Fluent in Farsi and English (spoken and written).
- Military service completion or exemption is required for male candidates.