Position Summary:

The individual is expected to actively contribute to the development and implementation of regulatory and scientific strategy for commercial and development products. The individual will also coordinate all aspects of product development and regulatory submissions relevant to the assigned projects or programs and serve as the regulatory and scientific representative on project teams.

Essential Functions:

  • Coordinate regulatory submissions relevant to the assigned projects or programs and serve as the regulatory representative on project teams;
  • Author technical reports and eCTD sections; manage, and execute submission preparations for FDA review and approval;
  • Review and provide comments on pre-clinical and clinical study protocols, CMC reports, SOPs, method development, validation protocols and reports, stability protocols, product specifications, comparability protocols and reports, quality agreements, and other related documents;
  • Provide direct oversight of CROs and/or consultants for assigned projects;
  • Prepare meeting requests and meeting briefing packages for FDA and other Regulatory Authorities on assigned projects, as appropriate;
  • Provide technical and scientific support for ongoing manufacturing operations at contract manufacturing organizations (CMOs) as well as internal sites, as needed;
  • Keep up-to-date on regulatory environment, proposing regulatory initiatives and changes to comply with Federal Register and FDA and ICH guidances;
  • Provide regulatory guidance during the review of change controls and deviations;
  • Develop global scientific and regulatory strategy for assigned commercial and development products.

Daily Responsibilities:

  • Prepare, collect, review and assemble technical documentation required for writing annual reports, clinical, preclinical, and CMC sections of IND, NDA, SNDA, and BLA;
  • Review Pre-clinical and Clinical protocols and reports , bioanalytical method validation and CMC reports;
  • Write regulatory submissions for assigned products;
  • Monitor Federal Register, USP, FDA and ICH websites;
  • Participate in cross-functional project teams (internal and external) as regulatory and scientific expert;
  • Liaise with senior management to align regulatory strategy with corporate goals;
  • Liaise with external companies and internal departments to ensure regulatory alliance;
  • Communicates with health authorities as necessary, directly and indirectly;
  • Serve as regulatory expect for project teams and junior regulatory staff.

Specific Job Knowledge, Skill and Ability:

  • At least 5+ years of experience in pharmaceutical industry
  • M. S. in Biology or Biochemistry ; advanced degree is preferable
  • Knowledge of GCP, GLP and GMP compliance, FDA guidelines and federal regulations
  • Prior experience authoring/managing CMC and other regulatory submissions
  • Strong regulatory writing skills
  • Strong analytical and technical problem solving skills
  • Strong planning and time management skills
  • Attention to detail and ability to multi-task
  • Demonstrated leader with the ability to work effectively in a collaborative work environment
  • Strong verbal and written communication skills

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