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Senior Associate, Regulatory Affairs

5+ years
$98,000 to $119,500
10 Nov. 28, 2024
Job Description
Job Type: Full Time Education: B.Sc./M.Sc./B.Pharm/M.Pharm/Life science 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

Position: Senior Regulatory Affairs Associate
Company: [Company Name]


Job Description

The Senior Regulatory Affairs Associate is responsible for preparing, reviewing, and submitting regulatory filings including New Drug Applications (NDAs), Abbreviated New Drug Applications (ANDAs), Drug Master Files (DMFs), Investigational New Drug applications (INDs), and related supplements (e.g., PAS, CBE-30, CBE). This position plays a critical role in ensuring regulatory compliance and supporting various departments, including Research & Development (R&D), by providing regulatory assessments and support for product submissions.


Key Responsibilities

Regulatory Submissions

  • Prepare, compile, review, and submit NDAs, ANDAs, DMFs, and INDs in eCTD format to the FDA.
  • Write and organize related modules (e.g., Mod 1) for NDA, ANDA, DMF, and IND submissions, ensuring compliance with FDA and ICH guidelines.
  • Review submissions for accuracy, consistency, and conformance with FDA regulations, ICH guidelines, USP requirements, and internal Standard Operating Procedures (SOPs).

Post-Marketing Activities and Supplements

  • Prepare and review post-marketing supplements, including PAS, CBE-30, and CBE, ensuring all changes meet FDA compliance standards.
  • Evaluate proposed changes (e.g., manufacturing processes, container closure systems, composition) and provide regulatory assessments based on FDA, ICH guidelines, and USP standards.
  • Support post-approval activities through review of change control forms related to product modifications.

Regulatory Support for R&D

  • Collaborate with R&D to prepare controlled correspondences for FDA submissions based on scientific rational and supporting data.
  • Evaluate prototype formulations, RLD labeling, and patents for future filings, ensuring compliance with FDA regulations and exclusivity periods.

Documentation and SOP Development

  • Write and maintain SOPs for regulatory procedures and ensure they are in line with current guidelines.
  • Maintain and update regulatory databases to ensure accurate tracking of submissions and approvals.

Qualifications

Experience

  • 3-5 years of regulatory affairs experience in the pharmaceutical industry.

Education

  • Bachelor’s or Master’s degree in a scientific discipline (e.g., Pharmacy, Chemistry, Life Sciences) or equivalent experience.

Skills

  • Strong written and verbal communication skills for drafting clear and concise regulatory documents.
  • Expertise in reviewing regulatory and scientific documents for adherence to requirements and identifying discrepancies.
  • Ability to manage multiple tasks in a dynamic environment and meet deadlines.
  • Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint) and familiarity with the FDA website for day-to-day tasks.

Additional Qualifications

  • Familiarity with eCTD submission formats and guidelines.
  • Knowledge of FDA regulations, ICH guidelines, and USP requirements.
  • Strong attention to detail and critical thinking skills.

Compensation & Benefits

  • Base Compensation: $98,000 - $119,500 (varies based on experience and location).
  • Annual Performance Bonus Plan: Eligibility for additional performance-based compensation.
  • Employee Benefits:
    • Medical, dental, and vision coverage
    • Life insurance
    • Disability insurance
    • 401(k) savings plan
    • Flexible spending accounts
    • Employee assistance program
  • Paid time off, including vacation and sick leave.

Equal Opportunity Employer

[Company Name] is an Equal Employment Opportunity/Affirmative Action employer. We provide equal opportunities for all applicants regardless of race, color, religion, sex, age, national origin, disability status, or any other characteristic protected by law.


Join us in ensuring that our products meet the highest regulatory standards and contribute to the health and well-being of patients. Apply now!