Idorsia US colleagues enjoy 100% of their health benefit premiums paid by Idorsia. We offer a 6% match for 401k and a healthy time off package. Compensation package includes base salary, short & long term incentives.
Internal Number: 3473
The Drug Regulatory Affairs (DRA) Global Project Leader is a multi-faceted clinical regulatory role with differing levels of responsibilities from global leader to partner role based on region/country in which the leader is employed and the region/country in which the assigned work is located.
Responsibilities include but are not limited to:
Global Role:
Define and provide optimal global regulatory strategies to support the development and approval of new drugs as well as product life-cycle management activities for assigned product(s)
Lead creation of regulatory function plans, including identification and critical assessment of regulatory issues
Provide consolidated interpretation of relevant Health Authority (HA) regulatory guidelines for the
development and approval of new drugs as well as product life-cycle management
Lead and ensure the global submission planning process, creation, review, and finalization of key
regulatory documents intended for submission to HAs
Represent DRA at LCT, CT, other project-related meetings, management committees and governance related meetings
Lead creation, review, finalization, and maintenance of CCDS for assigned products reaching this stage
Establish and lead Regulatory sub-teams at relevant points in development with communication of
plans and updates on a regular basis
Ensure communication and regulatory support for other countries as needed
Collaborate closely with the EU-based DRA project partner for regulatory considerations, strategy and key regulatory documents on assigned projects
Ensure that DRA project milestones are achieve
US Partner Role:
Provide US regulatory strategic input, including interpretation of guidelines relevant to the development and maintenance of assigned project(s) to Global DRA Project Leader, Clinical Team (CT), Technical Operations and/or Life Cycle Team (LCT)
Liaise with FDA and other US agencies as primary regulatory contact for assigned projects including planning, coordination, preparation and execution of meetings and teleconferences
Ensure appropriate communication of correspondence from FDA to colleagues, teams and
management in accordance with agreed communication routes
Lead creation and maintenance of competitive US labeling (package insert and associated documents) in compliance with Company Core Data Sheet (CCDS) and FDA regulations
Responsible for and contributes to ensuring creation, critical review, finalization of US-specific regulatory documents, i.e. IND applications, annual reports, FDA meeting briefing documents, Orphan Drug Applications, PPSR/WR, Module 1 documents for US NDA, sNDA labeling supplements, etc.
Remain current on Regulatory Intelligence, new guidance documents and competitive information to provide fully informed information to teams and development programs Contribute the US regulatory perspective as required on due diligence activities in support of potential new business opportunities
Qualifications:
Bachelor's Degree in life sciences
5 or more years of clinical regulatory experience including in-depth knowledge and experience with FDA regulatory aspects of prescription drug development: all aspects of 21 CFR 312, and 21 CFR 314. Experience with various types of US submissions.
Knowledge of regulatory legislation and guidelines (ICH and EU) and other major regulatory systems
Understanding of the regulatory aspects at various stages of development, from entry-into-man to post-approval activities
Experience working and communicating with the FDA, including coordinating, and managing meetings for scientific advice
Familiarity with clinical trial methodology and statistics
Excellent communication, interpersonal, negotiation and problem-solving skills
Organizational awareness (e.g. understands interrelationships between functions, departments and business priorities)
Effective team player, with experience working in cross-functional and global teams, but also able to work independently
Ability to work within tight timelines with excellent project management skills
Idorsia is a high-potential biopharmaceutical company, with an experienced team of over 1,200 highly qualified professionals, a full R&D pipeline, state-of-the-art facilities, and a strong balance sheet – the ideal constellation for bringing successful medicines to the market.
We began our operations after demerging from Actelion following its acquisition by Johnson & Johnson in 2017. At that time, approximately 650 talented and engaged employees were transferred to Idorsia, together with the discovery pipeline and early-stage clinical assets.
Idorsia is specialized in the discovery and development of small molecules, with the aim of transforming the horizon of therapeutic options. We have a broad, diversified and balanced development pipeline, covering multiple therapeutic areas. Our clinical pipeline comprises 11 assets, 6 of which are in late-stage development, and we expect to see two product launches in two of the largest pharmaceutical markets in the second quarter of 2022. With this in mind, we have built a commercial organization to bring our products to patients.
Idorsia is a start-up like no other!
