Regulatory Affairs Manager Job at Planet Pharma, Bristol, TN

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  • Planet Pharma
  • Bristol, TN

Job Description

We are seeking a Regulatory Affairs Manager or Regulatory Affairs Specialist with a strong background in oral solid dose pharmaceuticals and hands-on experience with CMC (Chemistry, Manufacturing & Controls) to support regulatory submissions and compliance activities. The ideal candidate will have direct experience authoring regulatory submissions, working with API and CMC change management , and have familiarity with scale-up activities . Candidates with exposure to Ad Promo, Pharmacovigilance, and stability requirements are a plus.

  • No third party vendors
  • Must be able to work onsite in TN
  • Relocation available

Key Responsibilities:

  • Support product lifecycle and post-approval activities through compilation, authoring, review, and submission of regulatory documents including:
  • NDA/ANDA filings , amendments, supplements, annual reports, DMF updates, and labeling packages
  • Ensure regulatory submissions comply with applicable FDA regulations and guidelines
  • Participate in and manage regulatory aspects of change control review and approval
  • Provide regulatory input on CMC-related issues and work closely with cross-functional teams (R&D, QA, QC, Manufacturing)
  • Maintain regulatory compliance throughout the product lifecycle, including stability requirement oversight
  • Collaborate on Ad Promo and Pharmacovigilance activities (as applicable)
  • Manage submission timelines and support regulatory project planning
  • Stay up-to-date on relevant FDA regulations and industry trends
  • Other responsibilities as assigned by management
  • Qualifications:
  • Bachelor’s degree in a scientific discipline (e.g., Chemistry, Biology, Pharmacy, Microbiology, Premed, Nursing)
  • Minimum of 2 years of regulatory affairs experience with RAC certification, or 4+ years of relevant pharmaceutical industry experience in a cGMP and/or FDA-regulated environment

Preferred Skills & Experience:

  • Solid understanding of oral solid dose formulations , scale-up , API , and CMC changes
  • Experience with FDA submissions and eCTD publishing
  • Familiarity with Ad Promo submissions and labeling/marketing material review
  • Knowledge of stability protocols and associated regulatory requirements
  • Strong understanding of FDA regulations, guidance documents, and ICH requirements
  • Excellent written and verbal communication skills

Job Tags

Relocation,

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