REGULATORY SUBMISSION SPECIALIST
CDI Geneva (Genève) Bachelor's Degree Legal
Job description
Job Description
Advanced Accelerator Applications is looking for a Regulatory Submission Specialist to join the Company’s global Regulatory team and support operations in our growing Geneva office.
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.
Position Title
REGULATORY SUBMISSION SPECIALIST
Desired profile
Minimum requirements
- 2-4 years regulatory experience
- 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.
- Professional proficiency in both spoken and written English.
- Ability to work independently (with minimal supervision) as well as work in a team environment with changing timelines and priorities.
- Demonstrated verbal and written communication skills.
- Ability to multi-task, pay close attention to detail, and follow projects through to completion.
- Bachelor’s degree preferred; Equivalent experience within the Regulatory Operations function will be considered
Job Type
Full Time
Company/Legal Entity
Advanced Accelerator Applications Switzerland SA
Country
Switzerland
Work Location
Geneva
Functional Area
Research & Development
Division
Oncology
Business Unit
Advanced Accelerator Applications
Employment Type
Regular
AAA Statement
Advanced Accelerator Applications, a Novartis company, is an innovative radiopharmaceutical company developing, producing and commercializing molecular nuclear medicine theragnostics. AAA offers professionals the opportunity to face new challenges and pursue a career in a fast growing, technology driven healthcare company. We are passionate about improving patient health by leading innovation in nuclear medicine. We are looking for people who share our commitment to help us achieve this goal. Advanced Accelerator Applications is an Equal Opportunity Employer (EOE).