Temporary DRA 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 company, 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 bringing R&D efforts to business success.

Idorsia was listed on the SIX Swiss Exchange (ticker symbol: IDIA) in June 2017 and has over 600 highly qualified specialists dedicated to realizing our ambitious targets.

 

Job Responsibilities

 

  • Assume EU regulatory responsibility for individual tasks or assigned project(s), such as the creation and finalization of key regulatory documents (e.g. IMPDs) as well as coordinating the preparation, review, finalization and ensuring submission to HA (EU) of e.g. scientific advice packages, PIPs, Orphan applications, Module 1 documents for EU, as well as supporting global submissions (e.g. MAA), variations, etc.
  • Provide EU regulatory input, including interpretation of guidelines relevant to the development and maintenance of assigned project(s) to Global DRA Project Leader, Clinical Team, Technical Operations and/or Life Cycle Team.
  • Liaise with EMA as primary regulatory contact and with other EU National Competent Authorities (NCA) in collaboration with affiliates and partners for assigned projects including planning, coordination, preparation and execution of meetings and teleconferences.
  • Ensure appropriate communication of correspondence from EMA/EU NCA to colleagues, teams and management in accordance with agreed communication routes.
  • Represent DRA (together with the Global DRA Project Leader) at life cycle, other project-related meetings, management committees and other governance-related meetings.
  • Collaborate closely with the US-based DRA partner for regulatory considerations on assigned projects.
  • Support Global DRA Project Leader with creation and finalization of strategic DRA documents such as Regulatory Functional Plan.
  • Ensure that regulatory files are adequately maintained.

 

 

 Candidate’s Requirements

 

  • Master's Degree in life sciences
  • Basic knowledge of regulatory legislation and guidelines (ICH and EU)
  • Basic understanding of the regulatory aspects at various stages of development, from entry-into-man to post-approval activities
  • Good communication, interpersonal, negotiation and problem-solving skills
  • Familiarity with clinical trial methodology and statistics
  • Capable of working independently as well as effective team player
  • Ability to work within tight timelines with very good project management skills
  • Accuracy, reliability and diligence
  • Excellent spoken and written English

 

What Idorsia offers

A collaborative and solution oriented environment where you can make a difference

An innovative and open culture in a truly multicultural environment

 

Work  Location: Allschwil

Country: Switzerland

Business Area: Clinical Development

Schedule: Fulltime

Job Type: Temporary (June - December 2019)

Job ID: 1152

 

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.

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