Senior Global DRA Project Leader EU

Location: 

Basel, 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 want to 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 bringing R&D efforts to business success.
Idorsia was listed on the SIX Swiss Exchange (ticker symbol: IDIA) in June 2017 and has over 1,100 highly qualified specialists dedicated to realizing our ambitious targets.

 

As Senior Global DRA Project Leader EU, you will be responsible to provide EU regulatory strategic input, including interpretation of guidelines relevant to the development and maintenance of assigned project(s) to Clinical Team(s), Technical Operations and/or Life Cycle Team(s).

 

 

Key responsibilities include but are not limited to:

 

 

  • Liaise with EMA as primary regulatory contact and with other EU NCA in collaboration with affiliates and partners for assigned projects including planning, coordination, preparation and execution of meetings and teleconferences
  • Represent DRA at LCT, CT, other project-related meetings, management committees and governance related meetings
  • Responsible for leading and coordinating the creation, critical review, finalization, and submission of EU-specific regulatory documents, i.e., IMPD, CHMP Scientific Advice and other meeting briefing books, annual reports, Orphan Drug Applications, PIP, Module 1 documents for EU MAA and for full MAA submissions, variations, etc.
  • Provide consolidated interpretation of relevant HA regulatory guidelines for the development and approval of new drugs as well as product life cycle management
  • Lead the global submission planning process, creation, review, and finalization of key regulatory documents intended for submission to HAs
  • Represent DRA at LCT, other project-related meetings and management committees
  • Ensure communication and regulatory support for other countries in collaboration with the affiliate or partners and regulatory operations, as needed

 

 

Candidate Requirements

 

  • Master's Degree in life sciences
  • At least 8 years’ experience in regulatory affairs in pharmaceutical industry
  • Expert knowledge of regulatory legislation and guidelines (ICH and EU) and major global regulatory systems
  • In-depth knowledge and experience with EMA and National Competent Authorities (NCA) in EU
  • Experience with various types of global submissions
  • Very good understanding of the regulatory aspects at various stages of development, from entry-into-man to post approval activities
  • In-depth experience working and communicating with the EMA/NCA, including coordinating, and managing Health Authority (HA) meetings, as well as experience working with other HAs globally
  • Excellent communication, interpersonal, negotiation and problem-solving skills
  • Effective team player, with experience working in cross-functional and global teams, but also able to work independently
  • Proven record of successfully managing projects with challenging milestones within a cross-functional organization
  • Excellent spoken and written English

             

 

Work  Location: Allschwil

Country: Switzerland

Business Area: Global Clinical Development, Drug Regulatory Affairs

Schedule: Fulltime

Job Type: Permanent

Job ID: 3466

 

At Idorsia, we harness the power of difference, authenticity, and inclusion to achieve business success.
We encourage all potential candidates with diverse backgrounds of race, color, religion, sexual orientation, gender identity, age, national origin, and disability to submit their job applications. All applicants will receive consideration.
We are committed to fostering respect, fairness, and equal opportunities for all job applicants and our employees.

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.