Director, Regulatory Strategy (US) - Start Up

Location: 

Cherry Hill, NJ, US

 

The purpose of Idorsia is to discover, develop and bring more, innovative medicines to patients. 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 a leading biopharmaceutical company, with a strong scientific core.

 

Headquartered near Basel, Switzerland, the US Commercial Operations & Clinical Development teams are based near Philadelphia, Pennsylvania.  Idorsia is committed to meet the changing needs of healthcare professionals, patients and their families.  The core of what we do is to bring creative solutions to the market based on our science and data.

 

The Global Drug Regulatory Affairs (DRA) Project Leader (US) role is dependent on the geographic region in which the leader is employed. For assigned projects the role may be the global leader or partner role.

 

US DRA Project Leader 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 in order 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

 

Global DRA Project Leader Role:

 

If the US DRA Project Leader is also the global leader on an assigned project, then the following responsibilities apply:

 

  • 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 achieved
  • Review critically all global promotional materials for marketed products

 

Other Activities:

 

  • Coach DRA Project Managers, DRA Trainees, or other DRA colleagues on defined activities
  • Represent Global DRA at governance-related meetings and deputize for Head US DRA on defined activities

 

Qualifications & Skills:

 

  • Bachelor's Degree in life sciences required; secondary degree (e.g. PhD) preferred
  • At least 8 years of regulatory experience
  • Expert knowledge of regulatory legislation and guidelines (ICH and EU) and other major regulatory systems
  • 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.
  • Good 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
  • Accuracy, reliability and diligence

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At Idorsia, we harness the power of difference, authenticity and inclusion to achieve business success. We are committed to fostering respect, fairness and equal opportunities for all job applicants and all our employees.  All qualified applicants will receive consideration for employment without regard to race, color, religion, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against based on disability.

 

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.

 


Nearest Major Market: Philadelphia