2 days ago

Regulatory Submission Specialist

Advanced Accelerator Applications

  • Work region
  • Sector
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  • Position

 


Advanced Accelerator Applications, a Novartis company, is an innovative radiopharmaceutical company developing, producing and commercializing molecular nuclear medicine theragnostics. AAA’s theragnostic platform is based on radiolabeling a targeting molecule with either gallium Ga 68 for diagnostic use, or lutetium Lu 177 for therapy. AAA’s first theragnostic pairing for neuroendocrine tumors includes diagnostic drugs NETSPOT® in the US and SomaKit TOC® in Europe; and therapeutic Lutathera® (USAN: lutetium Lu 177 dotatate/INN: lutetium (177Lu) oxodotreotide). Additional theragnostics in development target gastrointestinal stromal tumors (GIST), and prostate and breast cancer. AAA is also an established leader in molecular nuclear diagnostic radiopharmaceuticals for PET and SPECT, mainly used in clinical oncology, cardiology and neurology. Headquartered in Saint-Genis-Pouilly, France, AAA currently has 20 production and R&D facilities, and more than 600 employees in 13 countries (France, Italy, the UK, Germany, Switzerland, Spain, Poland, Portugal, The Netherlands, Belgium, Israel, the US and Canada). For more information, please visit: www.adacap.com.


 


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.

Regulatory Submission Specialist

 


Advanced Accelerator Applications, a Novartis company, is an innovative radiopharmaceutical company developing, producing and commercializing molecular nuclear medicine theragnostics. AAA’s theragnostic platform is based on radiolabeling a targeting molecule with either gallium Ga 68 for diagnostic use, or lutetium Lu 177 for therapy. AAA’s first theragnostic pairing for neuroendocrine tumors includes diagnostic drugs NETSPOT® in the US and SomaKit TOC® in Europe; and therapeutic Lutathera® (USAN: lutetium Lu 177 dotatate/INN: lutetium (177Lu) oxodotreotide). Additional theragnostics in development target gastrointestinal stromal tumors (GIST), and prostate and breast cancer. AAA is also an established leader in molecular nuclear diagnostic radiopharmaceuticals for PET and SPECT, mainly used in clinical oncology, cardiology and neurology. Headquartered in Saint-Genis-Pouilly, France, AAA currently has 20 production and R&D facilities, and more than 600 employees in 13 countries (France, Italy, the UK, Germany, Switzerland, Spain, Poland, Portugal, The Netherlands, Belgium, Israel, the US and Canada). For more information, please visit: www.adacap.com.


 


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.

 


 


 


Professional skills and experience


  • 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

4 rue de la Tour de l'Ile 1204 Genève