REGULATORY SUBMISSION SPECIALIST - SANDOZ - Geneva - Wizbii

REGULATORY SUBMISSION SPECIALIST

  • Par SANDOZ
  • CDI
  • Geneva (Switzerland)
  • Bachelor's Degree
  • Droit / Notariat / Fiscalité
2018-07-04T09:38:27+0000

Description de l'offre

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

Profil recherché

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).
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À propos de SANDOZ

Sandoz, une division de Novartis, est un leader mondial parmi les fabricants de médicaments génériques. Sandoz (26400 collaborateurs répartis parmi 130 pays avec un CA de 9.6 milliards USD en 2014) met à disposition des patients et des professionnels de santé des médicaments de qualité dont les prix maitrisés facilitent l’accès aux soins et contribuent à l’optimisation des dépenses de santé. Sandoz France fonde son développement sur la confiance des patients, de ses clients, de ses partenaires et appuie son succès sur : une recherche permanente de l’innovation, tant pour ses produits (génériques et biosimilaires) que pour ses actions ; Un portefeuille large, qui inclut une offre croissante de biosimilaires et qui répond aux besoins essentiels de santé publique ; Le savoir-faire industriel du Groupe Novartis, et de plus de 40 partenaires français ; L’engagement d’équipes fières et responsables, réunies autour d’une vision commune et de valeurs partagées.

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