Advanced Accelerator Applications (AAA) is an innovative radiopharmaceutical company that develops, produces and commercializes Molecular Nuclear Medicine (MNM) products. AAA’s lead therapeutic product candidate, Lutathera ® , is a novel MNM compound that AAA is currently developing for the treatment of neuroendocrine tumors, a significant unmet medical need. Founded in 2002, AAA has its headquarters in Saint-Genis-Pouilly, France. AAA currently has 22 production and R&D facilities able to manufacture both diagnostics and therapeutic MNM products, and has over 530 employees in 13 countries (France, Italy, UK, Germany, Switzerland, Spain, Poland, Portugal, The Netherlands, Belgium, Israel, U.S. and Canada). AAA reported sales of €109.3 million in 2016 (+23% vs. 2015). AAA is listed on the Nasdaq Global Select Market under the ticker “AAAP”. For more information, please visit: www.adacap.com .
Advanced Accelerator Applications AAA is an innovative radiopharmaceutical company that develops produces and commercializes Molecular Nuclear Medicine MNM products. AAA's lead therapeutic product candidate Lutathera reg is a novel MNM compound that AAA is currently developing for the treatment of neuroendocrine tumors a significant unmet medical need. Founded in 2002 AAA has its headquarters in Saint-Genis-Pouilly France. AAA currently has 22 production and R D facilities able to manufacture both diagnostics and therapeutic MNM products and has over 530 employees in 13 countries France Italy UK Germany Switzerland Spain Poland Portugal The Netherlands Belgium Israel U.S. and Canada . AAA reported sales of euro 109.3 million in 2016 +23% vs. 2015 . AAA is listed on the Nasdaq Global Select Market under the ticker ldquo AAAP rdquo . For more information please visit www.adacap.com. M/F REGULATORY SUBMISSION SPECIALIST
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.
Perform and coordinate submission of pre- and post-authorization regulatory activities such as clinical trial applications new marketing authorization applications and lifecycle management activities including but not limited to renewals variations PSURs etc.
Prepare administrative documents for 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 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
Submission of your application
We offer you a challenging position within an innovative dynamic international and goal-oriented working environment where your contribution can make a difference.
Compensation is competitive and based on your professional and educational background.
Please send your application in English via email to HR_CH@adacap.com. Your application shall include all the information you consider relevant and at a minimum a motivation letter your personal data education employment history and details on your current position.
Please note that we will only reply to candidates that we wish to bring to interview stage.
4 rue de la Tour de l'Ile 1204 Genève