Beschreibung
Global pharmaceutical company specialising in oncology therapies is currently looking for aa Regulatory Submission Specialist to join a busy team and support all tasks related to new products submission and existing products.
Key tasks:
- Perform and coordinate submission of pre- and post-authorization regulatory
activities, such as clinical trial applications (CTAs), new marketing
authorization applications (MAAs) and lifecycle management activities,
including but not limited to renewals, variations, PSURs etc.
- Prepare regulatory affairs submission according to requirements of the
relevant authorities (EMA, EU National Competent Authorities, Swissmedic
etc.)
- Prepare electronic applications in eCTD format in support of the company's
regulatory activities,
- Liaise with the regulatory authorities to ensure timely assessment, linguistic
review and approval.
- Perform document management tasks including file transfer, storage,
tracking, and archival of regulatory submission documentation.
- Apply company style guide formatting requirements to create submission
ready documents that are compliant with internal and heath agency
requirements.
- Provide regulatory operations guidance and information to Regulatory Affairs
department and submission project teams in relation to eSubmission and
procedural guidance.
- Assist in the mentoring and training of Regulatory and cross-functional team
members; prepare and maintain training materials.
Professional skills and experience:
- 2-4 years regulatory experience
- Bachelor's degree preferred; Equivalent experience within the Regulatory
operations function will be considered
- Knowledgeable in regulatory procedures (CTAs, MAAs and post-authorization
submissions) in MRP / DCP and centralized procedures
- Knowledgeable in CTD/eCTD structure and requirements and firm
understanding of submission requirements for EU submission types
- Proficiency in publishing and compilation of eCTD submissions, eCTD
validation and viewing tools (knowledge of eCTDmanager is a plus)
- Proficiency in MS Word and Adobe Acrobat; strong formatting skills and use
of templates.
- Ability to work independently (with minimal supervision) as well as work in a
team environment with changing timelines and priorities.
This is a permanent role in Geneva region. The company offers exciting projects to work on and great opportunities for growth and development.
Please send your CV
Michael Bailey International is acting as an Employment Agency in relation to this vacancy.