Job Description: Regulatory Operations Specialist (Talent Pool)
Location: Budapest, Hungary
Contract Type: Talent Pool (Position may not be actively recruiting)
About Roche
At Roche, we are leading the way in healthcare innovation with a focus on improving the lives of patients around the world. Our success is built on the dedication, curiosity, and diversity of our people. We believe in making a lasting difference by delivering high-quality services and products. Roche’s global reach allows us to collaborate across borders and cultures, and we’re committed to driving innovation in healthcare.
The Opportunity
We are looking for a Regulatory Operations Specialist to join our team within the Pharma Technical Regulatory (PTR) division. This is a talent pool opportunity, meaning you could be considered for future openings in the role. As part of this team, you will help prepare, manage, and submit regulatory documents while adhering to strict guidelines and Roche’s internal standards. This position is key in maintaining regulatory documents and ensuring smooth submission processes across teams.
Key Responsibilities
Document Management and Formatting:
Maintain regulatory documents in systems such as Documentum, SharePoint, and other regulatory information management systems (RIM).
Prepare, update, and format technical regulatory documents according to Roche's CMC standards and regulatory requirements (e.g., CTD – Common Technical Document).
Compile and format regulatory dossiers for publishing and submit them according to submission timelines.
Data Management and Metrics Analysis:
Perform data entry into global regulatory systems and generate reports and metrics for analysis.
Conduct trend analysis to ensure data consistency and provide insights to improve submission processes.
Collaboration and Coordination:
Work closely with PTR product managers and internal teams to ensure timely delivery of documentation.
Engage with submission leads and teams across different countries to manage assignments effectively.
Process Improvement:
Contribute to initiatives aimed at enhancing regulatory operations and improving efficiencies.
Participate in regulatory support services (RSS) and PTR initiatives to optimize team performance and service quality.
Who You Are
Experience and Skills:
2-5 years of relevant experience in regulatory operations, preferably in the pharmaceutical industry.
A degree in biology, chemistry, pharmacy, or a related field is required.
Expertise in Word, Excel, Acrobat, and experience with document-management systems (e.g., Documentum) and document-sharing systems (SharePoint).
Strong attention to detail and ability to format technical documents to a high standard using electronic tools.
Personal Qualities:
Strong organizational and time-management skills, with the ability to work independently under pressure and meet deadlines.
Aptitude for teamwork and a collaborative approach when interfacing with cross-functional teams.
Adaptable and willing to take on new assignments as priorities change.
Language Skills:
Fluency in written and spoken English.
Why Join Roche?
Development Opportunities:
Roche provides constant learning opportunities, including free language courses, internal training programs, and the possibility of international assignments.
Flexible Work Environment:
Enjoy a competitive salary, cafeteria package, annual bonus, and private medical services. We support work-life balance with flexible work practices, including remote working options.
Inclusive Global Culture:
At Roche, you’ll join a diverse team where you can collaborate, learn, and grow. Our leadership is focused on creating a strong and inclusive culture, where every voice matters.
Roche is an Equal Opportunity Employer
We value diversity and inclusion in all its forms and believe that every employee’s unique background and perspective makes us stronger. Join Roche and be part of a team that is dedicated to changing healthcare for the better.
For more information on how we handle your personal data during the recruitment process, please read our Data Privacy Notice.
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