Regulatory EU Submissions Excellence Expert
Job title: Regulatory EU Submissions Excellence Expert
Location: Budapest, Hungary
Flexible working: 60% home, 40% office
Job type: Permanent, full-time
About the job
The focus of the role is to support Global Regulatory Affairs (GRA) EU Region to support differed activity countries. The GRA EU Submission Excellence Expert will work closely with the Partner Markets Europe team, as well as Ukraine and Israel.
The GRA EU Submission Excellence Expert will be responsible for the post-approval changes dossier evaluation, preparation, and dispatch to the countries for submission in line with local regulations and planning set up by Global/Regional Business Unit (BU)/Country regulatory team.
These tasks can be delegated to a service provider and will be supervised by the GRA EU Submission Excellence Expert.
The GRA EU Submission Excellence Expert will report to on dotted line to the Global Regulatory Affairs EU Partner Markets Head (GRA EU PME) and full line to the Head Global Regulatory Services Hub.
- Plan, assess, coordinate and prepare regulatory dossier according to the country regulatory requirements relating to Labelling, CMC, administrative, renewal, Site registration, and /or any type of response documents to the Health Authorities questions by interacting with the relevant stakeholders (GRA, Partner, Countries) and monitoring of dossiers dispatch up to submission.
- Ensure regulatory compliance with products overall strategies and Health authorities country requirements evolution.
- Be compliant with all internal and external requirements, procedures and tools.
- Implement in timely manner Regional BU/country planning dispatch and ensure alignment with RA BU region and country activities.
- Maintain a good working relationship with internal and external stakeholders, be a business partner for the BU/Country regulatory team.
- Ensure to provide pharmaceutical expertise of the scientific technical documentation within the organization, ensuring total compliance with local requirements and ethical norms; provide validation support and technical advice; anticipate problems and actively seek alternatives and be proactive in proposing solutions.
- Accountable for keeping the databases updated on a timely basis for portfolio he/she is in charge of.
- Follow regulatory changes, competitor’s status and assess potential impact on daily activities and project strategy.
- Training: Foster the establishment of a learning/continuous improvement culture driven by metrics, benchmarking and best practices. Support the development newcomers and relevant training plan.
Knowledge, Skills & Competencies
- Experience within regulatory affairs department in a pharmaceutical company including life cycle management activities, creating final dossiers based on country requirements, supporting the submissions and post marketing experience is desirable.
- Knowledge and operational experience of EU/ US regulations and Good Manufacturing practices is nice to have.
- Soft skills:
- Highly self-motivated, pro-active, open minded, responsible, and autonomous individual.
- Established ability to problem solve user issues. Demonstrates critical thinking and is highly analytical in their approach.
- Excellent verbal, written, organizational and interpersonal skills and assertive in approach, not afraid to ask for help as and when required.
- With a sharp attention to detail and the ability to handle multiple tasks simultaneously.
- Collaborative team player with orientation towards building and maintaining effective relationships, strong culture awareness.
- Ability to work under pressure, adaptability to change, solve problems and willingness to learn to drive to meet short deadlines and shifting priorities.
- Ability to work with multifunctional and multicultural teams in a matrix organization.
- Technical skills:
- Working knowledge in Microsoft Office and Windows (Outlook, Word, Excel, PowerPoint), web skills a plus.
- Hands-on knowledge of Veeva Vault tools is a plus.
- Project management and/or coordination experience is a plus.
- Bachelor’s degree or Masters or equivalent in Life Sciences, Pharmacy or related.
- Excellent written and verbal communication skills in English.
When joining our team, you will experience:
- An international work environment, in which you can develop your talent and realize ideas and innovations within a competent team.
- An attractive, market-oriented salary and cafeteria benefits.
- Flexible home office policy, with a possibility to work up to 60% of time from home / where you can easily schedule your office days.
- Work from an "Office of the Year 2020" finalist office.
- Collective life and accident insurance.
- Yearly medical check-up.
- An individual and well-structured introduction and training of new employees and we will dedicate a Buddy for you to better navigate in your first weeks.
- Your own career path within Sanofi. Your professional and personal development will be supported purposefully.
- Join a great community & special events (Monthly Board Game Nights, Summer Events, Well-Being Lectures & Sport Clubs).
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