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Associate Director, Regulatory Affairs Development Strategy

Plano, TX, USA | Reata Pharmaceuticals, Inc.

  • Industry:
    Pharmaceutical / Biotech
  • Position Type:
  • Functions:
    General Management
    Regulatory Affairs
    Strategy
  • Experience:
    7-10 years
Job Description:
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The Associate Director, Regulatory Affairs Development Strategy provides regulatory guidance necessary to support project development teams. This position is responsible for managing assembly of regulatory documents for review and submission to health authorities.


RESPONSIBILITIES:


Working closely with the Global Regulatory Leader, help develop global regulatory strategies to progress development of Reata drugs

Provide project leadership to support execution of regulatory strategies including working closely with the Regulatory team and development teams to prepare regulatory plans (content plan and timeline) for the creation of document packages for regulatory submissions and management of document package preparation

Provide assistancein the preparation for meetings with global health authorities, and participate in the leadership of these meetings, as appropriate

Effectively coordinate with Regulatory Operations and Submission Management to ensure on-time preparation and publishing of regulatory submission documents

Identify and provide regulatory interpretation of regulations and guidance

Prepare information or responses as requested by regulatory agencies

Review clinical protocols to ensure collection of data needed to meet regulatory objectives and requirements

Ensure regulatory documentation is maintained appropriately


CORPORATE COMMITMENTS:


Demonstrate commitment and support for company goals, objectives and procedures

Represent Reata by developing collaborative relationships with site personnel, colleagues and vendors

Demonstrate professionalism and adherence to moral, ethical and quality principles

Participate in corporate and departmental meetings

Comply with applicable regulations, GCP and corporate policies and procedures


QUALIFICATIONS:


BA/BS or MS in life sciences

Minimum of 7 years pharmaceutical/biopharmaceutical

You must have a solid foundation in science obtained through academic and business experience  


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