Senior Technical Regulatory Affairs Project Manager

Location: 

Basel Area- Allschwil, BL, CH

 

 

About Idorsia Pharmaceuticals Ltd

Idorsia Ltd is reaching out for more - We have more ideas, we see more opportunities and we want to help more patients.

In order to achieve this, we will develop Idorsia into one of Europe’s leading biopharmaceutical companies, with a strong scientific core.

Headquartered in Switzerland - a European biotech hub - Idorsia is specialized in the discovery and development of small molecules, to transform the horizon of therapeutic options. Idorsia has a broad portfolio of innovative drugs in the pipeline, an experienced team, a fully-functional research center, and a strong balance sheet – the ideal constellation to bring R&D efforts to business success.

Idorsia was listed on the SIX Swiss Exchange (ticker symbol: IDIA) in June 2017 and has over 800 highly qualified specialists dedicated to realizing our ambitious targets.

 

We are looking for an enthusiastic and motivated Senior Technical Regulatory Affairs Project Manager to join our team !

 

Responsibilities

 

  • Write and update the Module 2 (Quality Overall Summary) and the Module 3 (drug substance and drug product quality sections) of the CTD/NDA Applications
  • Write and update the Quality part of the IMPD/INDs for clinical trials applications (Entry to Man, up to Phase III studies)
  • Support and advise the project team regarding pharmaceutical development related to regulatory strategy for submission.
  • Prepare the answers to the CMC questions raised by the Health Authorities following the submission of Marketing /Clinical Trial Applications and technical variations
  • Prepare Briefing Books and supportive documentation for Health Authority meetings (pre-IND, pre-NDA, End of Phase II, Scientific Advice meetings)
  • Attend Health Authority meetings to discuss pharmaceutical development related to regulatory strategy for submission.
  • Ensure consistency between raw data and registration documents contents
  • Provide assistance to Quality Assurance in ensuring the company compliance with GMP and regulatory guidances (ICH, FDA, EMA, PMDA, ...)
  • Evaluate the regulatory impact of the technical changes as well as the investigations needed before implementation. Prepare the new registration documents.

 

Requirements 

 

  • University degree (Msc, PhD) in Chemistry or Pharmacist (Pharm D)
  • Knowledge of, and understanding of ICH guidelines (Quality)
  • Minimum of 5 years’ experience in technical regulatory affairs (CMC writer of Quality sections of IND/IMPD/NDA/CTDs) 
  • Very good verbal and written communication skills in English 
  • An enthusiastic, team-spirit and committed approach to delivering high quality results, and the confidence and flexibility to do this in a demanding environment
  • Ability to work independently
  • Proven record to manage multiple tasks with competing priorities 

 

What Idorsia offers

 

  • Exciting opportunities for development and professional growth within our dynamic organization
  • A collaborative and solution-oriented environment where you can make a difference
  • An innovative and open culture in a truly multicultural environment
  • A competitive salary and generous benefits


Work  Location: Basel Area - Allschwil

Country: Switzerland

Business Area: Pharmaceutical Development - Technical Regulatory Affairs

Schedule: Fulltime

Job Type: Permanent

Job ID: 1986

 

If you are interested, please click on apply now.

Please be informed that if you are selected for this position, your employment will be subject to a pre-employment background screening process, of which you would be informed in greater detail in due course.

Please note Idorsia operates a strictly-controlled list of preferred recruitment partners. For those partners who have no valid, signed Master Service Agreement in place with Idorsia all unsolicited resumes, CVs, anonymous profiles, or any other candidate details submitted through our website or to personal e-mail accounts of employees of Idorsia Pharmaceuticals (including any of its subsidiaries, affiliates or related companies) are considered the property of Idorsia Pharmaceuticals and are not subject to payment of any form of introduction, placement or referral fees.