Associate Director, Global DRA Project Leader

Location: 

Philadelphia Area, Cherry Hill, PA, US

 

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 companies, with a strong scientific core.

 

Headquartered in Switzerland, 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 has US operations based in Cherry Hill, New Jersey with 20 professionals supporting the clinical development of our innovative pipeline in North America.

 

 

Job Responsibilities

 

The DRA Project Leader 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.

 

  • 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
  • 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

 

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

 

 

Candidate Requirements

 

  • Bachelor's Degree in life sciences; secondary degree (e.g. PhD) preferred
  • Regulatory Affairs Certification (RAC) preferred
  • At least 5 years of regulatory experience
  • Good 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

 

 

Physical Requirements

 

  • Talk, hear, and use fingers and hands to perform repetitive motions (computer work).
  • Carry up to 20 pounds of weight occasionally.
  • Close visual acuity to perform activities such as preparing and analyzing data and figures.

 

 

What Idorsia offers

 

  • Potential to telecommute 1-2 days a week (after 90-day probation period) with supervisor approval
  • Exciting opportunities for development and professional growth within our dynamic organization
  • 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 benefits

 

Work  Location: Philadelphia Area - Cherry Hill

Country: USA

Business Area: Global Clinical Development

Schedule: Fulltime

Job Type: Permanent

Job ID: 1294

 

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.


Nearest Major Market: Erie