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 across the world. Our success is rooted in the diversity, curiosity, and passion of our employees. With more than 100,000 people in over 100 countries, Roche is a global leader in research-driven healthcare. Our mission is to push back the frontiers of healthcare, and we need dedicated professionals to join us in this journey.
The Opportunity
The Regulatory Operations Group plays a pivotal role in Roche's Product Development Regulatory (PDR) organization. We are seeking individuals for our Talent Pool to fill potential future openings within the team. In this role, you will be involved in the preparation, compilation, publishing, and submission of regulatory applications, ensuring that all documentation is accurate, complete, and relevant. This role provides an excellent opportunity to develop your expertise in regulatory submissions, clinical trials, and related operations.
Key Responsibilities
Document Management and Submission:
Provide technical documentation support in the preparation and formatting of regulatory documents.
Compile submission dossiers and ensure the accuracy of regulatory information in systems.
Maintain and manage regulatory documents in regulatory information management systems (RIM, Documentum) and document-sharing systems (SharePoint).
Collaboration and Knowledge Sharing:
Work closely with submission leads and teams across multiple countries to ensure smooth operations.
Help build a knowledge base by applying best practices in regulatory submissions and clinical trial management.
Process Improvement:
Contribute to continuous process improvements and quality exercises within the team.
Mentor and train new team members, providing guidance to enhance team performance.
Stakeholder Engagement:
Build relationships with teams in other departments and regulatory functions, supporting the flow of information and ensuring operational efficiency.
Who You Are
Experience and Skills:
1-3 years of relevant experience, ideally with a life sciences or data/system-related degree.
Proficiency in Word, Excel, Acrobat, and experience with document-management systems (e.g., Documentum, SharePoint).
Strong attention to detail, ensuring data consistency, document formatting, and style consistency.
Ability to interface effectively with teams across different regions and collaborate in global teams.
Personal Qualities:
Self-motivated and passionate about delivering high-quality service.
Open-minded and dedicated to making a difference.
Excellent organizational skills with the ability to manage multiple tasks in a fast-paced environment.
Language Skills:
Fluent in written and spoken English.
Why Join Roche?
Development Opportunities:
Roche offers extensive learning resources and development opportunities, including free language courses, trainings, international assignments, and the chance to shape your career.
Flexible Work Environment:
Roche provides excellent benefits including a competitive salary, cafeteria package, annual bonus, private medical services, and more. We ensure work-life balance through flexible working options, including home office practices.
Global and Diverse Community:
Join a diverse, inclusive team where you can learn, collaborate, and grow. Roche fosters a culture of innovation, teamwork, and mutual respect.
Roche is an Equal Opportunity Employer
We are committed to creating an inclusive environment for all employees. We value diversity and embrace individuals from different backgrounds, ensuring every employee can contribute their best work.
If you're passionate about regulatory operations and want to be part of a company that values diversity, innovation, and impact, apply today and be part of Roche's dynamic and transformative journey in healthcare!
Gujarat :
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Banasthali | Bhiwadi | Jaipur | Pilani | Udaipur |Karnataka :
Bangalore | Belgaum | Bengaluru | B.G Nagara | Bommasandra | Colorado | Czech Republic | Karnataka | Mangaluru | Mysore | Udupi |Punjab :
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Delhi | India | New Delhi | PAN-India |Assam :
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Digha | Kolkata | Mukundapur |Uttar Pradesh :
Gajraula | Gautam buddha Nagar | Ghaziabad | Gorakhpur | Greater Noida | Jhansi | Lucknow | Mathura | Noida | Park City | Prayagraj | Satyamev | Varanasi |Goa :
Goa | Panaji | Verna |Bihar :
Hajipur | Patna |Kerala :
Kannur | Kochi | Malappuram | Thiruvananthapuram | Trivandrum |Pondicherry (Puducherry) :
Pondicherry (Puducherry) |Jharkhand :
Ranchi |Sikkim :
Rangpo |India :
Siliguri |Illinois :
Abbott Park | Bloomingdale | Champaign | Chicago | Deerfield | Glenview | Lake Forest | Lombard | Naperville | Norridge | Park RIdge | Round Lake |Maryland :
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Anchorage | Barrow | Bethel | Juneau | Sitka | Wrangell |Massachusetts :
Andover | Billerica | Boston | Cambridge | Devens | Lexington | Massachusetts | Medford and Somerville | Rockland |Wisconsin :
Appleton | Kenosha | Pleasant Prairie | Portage | Waukesha |United states :
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Basking Ridge | Bloomfield | Branchburg Township | Bridgewater | Brunswick | Burlington | Charlotte | Clark | Cranbury | Dunellen | East Brunswick | Edison | Fairfield | Far Hills | Flemington | Hackensack | Hopewell | Indianapolis | Jersey City | Linden | Livingston | Lyndhurst | Mahwah | Monmouth Junction | Montville | Mount Arlington | Newark | New Brunswick | Nutley | Paramus | Parsippany | Passaic | Paterson | Peapack-Gladstone | Pine Brook | Piscataway Township | Plainsboro | Princeton Junction | Rahway | Raritan | Somerset | Somerville | South Plainfield | Sparta | Summit | Titusville | Trenton | Warren Grove | Westfield | West Orange | Wharton | Whippany |Ohio :
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Europe | France | Latvia | Lendava | Leuven | Poland | Slovenia | Spain |Finland :
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Arkansas | Remote Australia |New South Wales :
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England | Harlow | Leeds | London | Maidenhead | Salt Lake City | Stevenage | Stirling | United Kingdom |North Yorkshire :
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Tallinn |Hà Nội :
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Bangkok |Israel :
Netanya | Tel Aviv | Yavne | Kfar Saba | Be'Er Sheva |Remote :
Hungary | McFarland | Faridabad | Thailand | French | Castlebar | Nairobi | Lousiana | Manipal | Green Way | Leinster | Hammond | Remote, USA | Melbourne | Switzerland | Minnesota | Remote | Zaragoza | Belgium | Medan | Blue Bell | Remote - Africa | Riga | Texas | Remote - South America (Latin Americal) | Victoria | Regulatory Labeling Manager (NA and LATAM Only) | Remote - Europe | Springville | Tulsa | Lenexa | Bountiful | Bishop | Ireland | Remote - Middle East | Slovakia | Xzagreb |Republic of Colombia :
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Kyiv |Lima Region :
Lima |France :
Lyon | Paris |South Africa :
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Niš |Bohemia :
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