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Senior Regulatory Affairs Associate (Labelling)

4+ years
Preffered by Company
10 Aug. 26, 2024
Job Description
Job Type: Full Time Education: B.Pharm/ M.Pharm/ B.Sc/ M.Sc/Any Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Join Us at Parexel – Where Our Shared Values Drive Achievements!

At Parexel, we are united by a common mission: to enhance global health through our work. Whether in clinical trials, regulatory affairs, consulting, or market access, our clinical development solutions are grounded in a profound commitment to what we do.

Every role at Parexel, regardless of function, contributes to the development of therapies that benefit patients. We approach our work with empathy and dedication, knowing that our efforts make a meaningful impact.

Position: Regulatory Affairs Labeling Specialist

Key Responsibilities:

  • Project Execution:

    • Manage drug development projects with a focus on labeling, product packaging, and clinical supplies/packaging.
    • Apply deep knowledge of key labeling regulations and guidance in label development (CCDS, USPI, packaging).
    • Research and create comparator labeling documents.
    • Develop and manage annual reports.
    • Collaborate with Tech Ops for artwork implementation.
    • Proficiently use SPL (Structured Product Labeling) for document management and approval.
    • Handle electronic document management systems and electronic submissions.
    • Oversee Life Cycle Management and post-approval labeling submissions, including PSUR submissions.
  • PAREXEL-Related Activities:

    • Achieve established metrics as per the annual scorecard.
    • Fulfill basic job responsibilities, including timesheets, expense reports, CV maintenance, and training compliance.
    • Participate in internal initiatives and projects as requested.
    • Pursue self-development activities to stay current within the industry, such as maintaining relevant memberships.
  • Skills:

    • Knowledge of project management and a client-focused approach.
    • Results-oriented with strong teamwork and collaboration skills.
    • Excellent interpersonal and intercultural communication skills, both written and verbal.
    • Critical thinking and problem-solving abilities.
    • Proficiency in local language and extensive knowledge of English.
  • Business Development:

    • Build and maintain a network of industry contacts through project engagements and other professional experiences.
    • Communicate potential new business opportunities to management and account managers.
    • Participate in project scoping calls and proposal preparations with senior support.

Knowledge and Experience:

  • Minimum of 4 years of relevant industry experience.

Education:

  • Bachelor’s Degree in a Scientific or Technical Discipline.

At Parexel, your work makes a difference. If you are passionate about contributing to the advancement of therapies and improving patient outcomes, we invite you to apply.