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 Opportunity

Doing now what patients need next. This is the purpose we follow at Roche to get better outcomes for our patients faster.
The role of Regulatory Affairs Manager is key in achieving this purpose through
developing regulatory strategies, managing regulatory projects and performing
associated activities to ensure the rapid and optimal registration for new Roche
Pharma products and indications in Iraq.

Regulatory Affairs Manager works closely with health authorities in Iraq in
coordination with Distributor to ensure ongoing regulatory compliance and
maintain existing registrations throughout a product’s lifecycle.

He/she plays an important role in delivering the key function of achieving timely
approval of and the broadest use of products for Roche in Iraq.

Main Responsibilities

- Set the regulatory strategy of the Iraq market and drive local implementation in coordination with relevant internal and external stakeholders (like the distributor) 

- Shape the regulatory environment by participating in industry associations on regulatory policy and regulations. Contribute to global regulatory strategies, considering local regulation and patients’ needs.
- Lead and develop risk-based regulatory strategies and workplans for all products across the Affiliate to accelerate access in alignment with global.
- Ensure regulatory inspection-readiness for the Affiliate, including leading or participating in internal/external regulatory audits. Ensure all Affiliate regulatory activities comply with Roche global standards and local regulations as well as regulatory compliance for product released to market according to marketing authorizations.
- Deliver on time the required regulatory information to all relevant colleagues who are responsible for particular products, and Keeps all relevant stakeholders like the pharmacovigilance personnel, Medical Director updated on relevant regulatory information
- Maintenance and regularly update local registration database for all Roche medicinal products registered in Iraq.
- Perform risk assessments related to regulatory compliance and product safety. Develop action plans to mitigate potential risks.

Who you are?

Required experience and qualifications

- University degree in medicine, pharmacy or other life sciences. Postgraduate degree in a related field is a privilege. 
- 5 or more years of previous regulatory experience in the pharmaceutical, biotechnology, or related industry.
- Previous regulatory experience in Iraq is a plus. 
- Expert knowledge of the industry’s Codes of Conduct and other relevant standards and guidelines.

- Fluency in Arabic and English oral and written.

Skills and Competencies

- Highly organized, with ability to prioritize own tasks as well as those of others.
-Strong written and verbal communication skills: communicates in a concise and clear manner that supports expeditious and effective decision-making. 
- Strategic agility.
- Strong influencing skills: can influence without authority and has proven experience building and cultivating relationships with key partners/stakeholders.
- Strong negotiation skills: can effectively drive discussions and decisions toward desired outcomes.
- Ability to work in a matrix model, across geographies and organization at all levels. Experience of resolving complex issues in a matrix organization

A healthier future drives us to innovate. Together, more than 100’000 employees across the globe are dedicated to advance science, ensuring everyone has access to healthcare today and for generations to come. Our efforts result in more than 26 million people treated with our medicines and over 30 billion tests conducted using our Diagnostics products. We empower each other to explore new possibilities, foster creativity, and keep our ambitions high, so we can deliver life-changing healthcare solutions that make a global impact.

Let’s build a healthier future, together.

Roche is an Equal Opportunity Employer.