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Senior Specialist - Regulatory Submission Management
A career at our company is an ongoing journey of discovery: our 58,000 people are shaping how the world lives, works and plays through next generation advancements in Healthcare, Life Science and Electronics. For more than 350 years and across the world we have passionately pursued our curiosity to find novel and vibrant ways of enhancing the lives of others.
United As One for Patients, our purpose in Healthcare is to help create, improve and prolong lives. We develop medicines, intelligent devices and innovative technologies in therapeutic areas such as Oncology, Neurology and Fertility. Our teams work together across 6 continents with passion and relentless curiosity in order to help patients at every stage of life. Joining our Healthcare team is becoming part of a diverse, inclusive and flexible working culture, presenting great opportunities for personal development and career advancement across the globe.
- Manage and execute planning, compilation and dispatch of submissions to Health Authorities during the application lifecycle.
- Create and update submission packages and Submission Content Plans for submissions to Health Authorities.
- Create and update records in Regulatory Information Management system and ensure submissions are documented properly including tracking of HA questions and documentation of approval and registration details in Veeva Vault RIM.
- Liaise and follow-up with R&D functions to provide required submission-relevant documents on time and in submission ready format.
- Perform quality checks, validate eCTD output, and submit eCTDs through supported HA gateway.
- Collaborate with submission management and publishing vendors, resolve or coordinate any queries, and perform spot checks on output.
- Functional oversight of vendors for submission management and publishing.
- Crisis intervention in case of vendor issues to avoid impact on quality or project timelines.
- Key contact for eCTD and Publishing expertise.
- Act as power-user for submission applications (Veeva Vault RIM).
- Author cover letter and application forms in close cooperation with the License Manager or Regulatory Lead.
- Monitor compliance with submission standards and submission process (internal & external).
- Manage and improve quality of submission standards and templates for submission-relevant documents ensuring compliance with HA requirements.
Who you are:
- Degree in a Life Science or related discipline
- 7-8 years experience in Regulatory Affairs or Regulatory Operations.
- Excellent spoken and written English.
Professional skills and experience:
- Minimum 3-4 years’ experience in submission management or publishing in eCTD, NeeS and paper format.
- Proven ability to handle regulatory applications needed to support the regulatory function according to the role.
- Strong project management skills, international project experience.
- Excellent organizational skills, work independently, self-motivated and proactive.
- Goal-oriented and pragmatic approach to work.
Personal skills and competencies:
- Excellent communication and interactive skills.
- Excellent interpersonal skills.
- Strong team player with ability to work with multidisciplinary teams within a matrix and in an international environment
What we offer: With us, there are always opportunities to break new ground. We empower you to fulfil your ambitions, and our diverse businesses offer various career moves to seek new horizons. We trust you with responsibility early on and support you to draw your own career map that is responsive to your aspirations and priorities in life. Join us and bring your curiosity to life!
Curious? Apply and find more information at https://jobs.vibrantm.com