Regulatory Affairs Business Lead
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Salary Not Disclosed
1 Vacancy
Job Description
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
The Opportunity
The Regulatory Affairs Business Lead is responsible for developing and executing submission and approval strategies for all regulatory activities ensuring ethical conduct and compliance with laws and regulations.
Your Responsibilities
Manage supervise and coach Regulatory Affairs associates to achieve the business objectives in terms of new Launches and life cycle maintenance activities.
Work with Affiliate DRA Head (Operations Director) to identify and recommend appropriate Regulatory Affairs resources and budget.
New product registration set up the strategy evaluate prepare and submit drug registration application in a timely manner and follow through the application during the evaluation phase to achieve a favorable outcome.
Direct engagement with local authorities in building business initiatives.
Provide Regulatory Affairs input into relevant 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 regulatory strategies and work plans for assigned products or business areas within the Affiliate to accelerate access in alignment with global.
Ensure the compliance of the Regulatory database systems content & data maintenance activities.
Support regulatory inspection-readiness for the Affiliate including leading or participating in internal/external regulatory audits (by ensuring the proper achieving system accurate and timely manner entries).
Interact and negotiate with local HAs external and internal stakeholders (meetings calls emails and visits).
Who You Are
Bachelors degree in Pharmacy Sciences.
7 years of experience preferably has worked in the field.
Efficient team management and leadership.
Fluency in communication in both languages (English & Arabic).
Proficiency in SAP system.
Who we are
A healthier future drives us to innovate. Together more than 100000 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.
Lets build a healthier future together.
Roche is an Equal Opportunity Employer.
Employment Type
Full-Time
