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 the Basel Area (Allschwil) 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 800 highly qualified specialists dedicated to realizing our ambitious targets.
Drug Regulatory Affairs Project Manager
Assume EU regulatory responsibility for individual tasks or assigned development project(s) across various therapeutic areas, such as the creation and finalization of regulatory documents (e.g. IMPDs) as well as coordinating the preparation, review, finalization of e.g. scientific advice packages, PIPs or Orphan drug applications.
Support the Global Drug Regulatory Affairs (DRA) Project Leader for the preparation of global submissions, e.g. Module 1 documents for MAAs or variations in the EU, Switzerland or Canada.
Provide regulatory input to the Global DRA Project Leader and project team, including interpretation of guidelines relevant to the development of assigned project(s) and analysis of precedents by searching for publicly available information, e.g. on Health Authority websites or other databases
Represent DRA (together with the Global DRA Project Leader) in project team meetings, management committees and other governance-related meetings.
Collaborate closely with the US-based DRA partner for regulatory considerations on assigned projects.
Liaise with Health Authorities as primary regulatory contact for assigned projects including planning, coordination, preparation and execution of meetings and teleconferences.
Ensure appropriate communication of correspondence from Health Authorities to colleagues, teams and management in accordance with agreed communication routes.
Ensure that regulatory files are adequately maintained.
Master's Degree in life sciences
1-2 years working experience within a Drug Regulatory Affairs environment
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
Organizational awareness (e.g. understands interrelationships between functions, departments and business priorities).
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
Exciting opportunities for development and professional growth within our dynamic organization
An opportunity to work simultaneously on several projects across various therapeutic areas, and be exposed to a wide range of regulatory activities from Entry into Humans to post-approval.
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 social benefits
Work Location: Allschwil - Basel Area Country: Switzerland Business Area: Global Clinical Development Schedule: Full-time Job Type: Permanent Job ID: 2578
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 will be informed in greater detail in due course.
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, please note that 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.