$ads={1}
Job Description
We are looking for you to join Roche and our Roche Services & Solutions Center in Budapest.
Roche is a global healthcare company offering exceptional career paths and great benefits for fresh graduates and outstanding professionals. We are continuously expanding, looking for new talents to join our transforming Services & Solutions Center. We offer a flexible working framework (1 office day/week on average) and provide fully remote working conditions within Hungary.
What we do:
The Regulatory Submissions Group is part of the broader PDR organization that interprets the needs of worldwide health authorities and provides regulatory intelligence necessary to generate and present information that meets the needs of health authorities, patients, purchasers, and prescribers for Roche’s global Pharma Medicines Division. PDR is responsible for the timely submission of applications to health authorities. The Regulatory Submissions Group provides coordination, compilation, publishing, and submissions expertise in the preparation of new and existing regulatory applications.
Responsibilities:
- Leads global regulatory submissions processes of low to moderate complexity
- Plans, coordinates, compiles, publishes, and submits regulatory applications, in compliance with health authority regulations worldwide
- Participates in project planning and is accountable to ensure submission requirements and timing are in alignment with overall project timelines
- Ensures documents are compliant with Roche standards, ICH, and other guidelines for incorporation into eCTD submissions using publishing and editing tools
- Partners with Submission Managers to work on more complex submission activities
- Supports Submission Managers with quality assurance/quality control checks to ensure overall submission quality
- Maintains and supports the implementation and updates of publishing systems - assisting with software validation, testing of new releases and new applications, and system implementation.
- May act as a Subject Matter Expert (SME) and/or support an SME for specific RSG activities
- As a core member in the Regulatory Affairs Functional Team (RAFT) for assigned product development projects as necessary, provides input on timelines and submission process
- As an ad hoc member of key functional and cross-functional Teams (e.g. GFT), provides input on timelines and submission process
- Coordination of EU Annexes
You bring the following skills and competencies:
- Strong attention to detail, organization, and time management skills
- Expresses thoughts, directions, and ideas in a clear and organized manner
- Uses decision-making skills to solve problems by selecting one course of action from several possible alternatives. If unclear, recognizes it and seeks support from a more senior team member
- Teamwork: Works effectively as global team member and in cross-functional teams
- Bachelor degree preferred
- Relevant experience in the pharmaceutical/biotechnology industry is preferred. Previous experience in regulatory affairs, quality, manufacturing or other product development functions is a plus.
- Demonstrated ability to prepare electronic and non-electronic, routine and non-routine, submissions as required by regulatory and departmental guidelines for submission to health authorities.
- Strong computer skills, including Microsoft Office Suite (Word, PowerPoint and Excel), Adobe Acrobat, relevant publishing and document management systems/software
- Fluent English is a requirement, other language skills are a plus
In exchange we provide you with:
Development opportunities: Roche is rich in learning resources. We provide constant development opportunities, free language courses & trainings, the possibility of international assignments, internal position changes and the chance to shape your own career.
Excellent benefits & flexibility: competitive salary and cafeteria package, annual bonus, language allowance (if the position requires extra language), Private Medical Services, Employee Assistance Program, All You Can Move Sportpass, coaching / mentoring opportunity, buddy program, team buildings, holiday party. We also ensure flexibility, to help you find your balance: home office is a common practice, and its conditions can be tailored for employees according to needs. We create the opportunity for freedom in working, where your corporate and private life coexist in harmony.
A global diverse community, where we learn from each other. At Roche, we cooperate, debate, make decisions, celebrate successes and have fun as a team. Our leadership is very focused on people, creating a strong, inclusive culture, so you always have the chance to share your opinion.
At Roche, more than 100,000 people across 100 countries are pushing back the frontiers of healthcare. Working together, we’ve become one of the world’s leading research-focused healthcare groups. Our success is built on innovation, curiosity and diversity.
The Roche Services & Solutions as well as People Support Solutions organisations located in Budapest provide end-to-end business solutions for Finance, Procurement, IT, Communications, People & Culture (Human Resources) and beyond to our Roche colleagues across the EMEA region. Today Roche employs altogether around 1400 employees in Hungary.
Roche is an Equal Opportunity Employer.
