WuXi AppTec

  • Regulatory Affairs Specialist

    Job Locations US-PA-Philadelphia
    Job ID
  • Overview

    The Regulatory Affairs Specialist is responsible for preparing on-time preparation and filing of high-quality regulatory submission files such as CMC, IND, DMF and  BLA's as well as support and obtain regulatory approvals, post-approval maintenance of regulatory dossiers, and maintain both quality and regulatory compliance.  In addition, this position will interact with project teams and regulatory agencies in relation to submissions, compliance, and other relevant topics.


    • Participates in the development and implementation of the regulatory strategy: compiles information and data pertaining to regulatory and project requirements; assesses needs; identifies the project’s critical factors; presents decision-makers with options; applies strategies.
    • Assembles a regulatory file/dossier: coordinates acquisition of all applicable data; assessed data; drafts and submits the regulatory file.
    • Monitors product files in the developmental phase: updates data; reconciles requests from authorities based on scientific and ethical constraints; makes amendments/changes and submits them to authorities.
    • Conducts regulatory monitoring of approved products: assists and supports in-house teams; maintains files current; ensures regulatory compliance; evaluates the effects of an amendment/change; takes appropriate regulatory actions.
    • Provides counselling to internal and external clients with regulatory issues: ensures regulatory monitoring; formulates a regulatory opinion; supports employees and the management team; represents the company; conveys information about regulatory matters and their application.
    • Communication and Interpersonal Skills: Ability to build relationships of trust and demonstrate professional ethics.
    • Preparation, Submission, and Follow-up of a Regulatory File
    • Properly documents all file data.
    • Diligently verifies that collected data comply with the regulations in effect.
    • Conducts proper assessments in order to anticipate questions and critical issues.
    • Clearly responds to questions from regulatory authorities.
    • Justifies position (legal, ethical, or scientific) when there are differences of opinion in connection with a request from regulatory authorities.
    • Regularly monitors commitments/obligations in response to regulatory requirements or requests.

    Job Specific requirements

    • Provides operational support for Quality, Manufacturing and Testing activities as it relates to Regulatory and Compliance
    • Works on routine assignments per written procedures, where ability to recognize deviation from accepted practice is required.
    • Normally receives minimal instructions on routine work and detailed instructions on new assignments.
    • Performs support functions for Quality Assurance
    • Ability to work in a team environment and independently as required
    • Contributes to the overall operations and to the achievement of departmental goals
    • Perform job specific tasks in compliance with applicable Regulations, International Standards, and WuXi AppTec Policies and Standard Operating Procedures.
    • Thorough understanding of Good Laboratory Practices and Good Manufacturing Practices
    • Other duties as assigned


    Experience / Education:       

    • 3-5 years of relevant experience or equivalent
    • A university degree in science (bachelor’s, master’s, doctorate) biology, chemistry, biochemistry, or a related discipline i.e. regulatory affairs


    Knowledge / Skills / Abilities:

    • Autonomy and leadership.
    • Ability to communicate effectively, negotiate, and persuade.
    • Ability to work on multiple projects at the same time.
    • Ability to keep tight deadlines and work under pressure.


    An Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability


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