Note: The job is a remote job and is open to candidates in USA. DataEdge Consulting is presenting an opportunity with a global pharmaceutical industry customer seeking an experienced Operations Director. The role provides nonclinical subject matter expertise across Women’s Health, General Medicines, and Biosimilars, supporting regulatory submissions, life-cycle management, pharmacovigilance, toxicology, pharmacology, DMPK, and CMC risk assessments.
Responsibilities
- Serve as the Nonclinical representative on ADTs in the development and execution of life-cycle management activities for products in the portfolio
- Author and review of nonclinical CTD modules, briefing books, or other regulatory communications for regional regulatory submissions or renewals for global products within the portfolio
- Nonclinical point of contact for Regulatory, Safety, and Pharmacovigilance activities support of the Women’s Health, General Medicines and Biosimilars product portfolio
- Nonclinical toxicology liaison with CMC and Occupational Safety to conduct risk assessments to inform mitigation strategies in accordance with regional and/or global regulatory requirements. Collaborate with CMC to assess process manufacturing impurities, degradants, and/or extraneous matters and conduct risk assessments to inform mitigation strategies in accordance with regional and/or global regulatory requirements
- Provide scientific and nonclinical input (toxicology, pharmacology, DMPK) for products and ADTs
- Prepare, contribute to and/or review the nonclinical or CMC documentation to support regulatory submissions to regional Health Authorities worldwide; may participate in interactions with Health Authorities
- Support Regulatory activities for global products such as, annual reporting of nonclinical activities and literature, support new regional drug applications, regional license renewals, author responses to questions from global Heath Authorities
- Support Drug Safety and Pharmacovigilance with activities such as review of nonclinical literature for new risks, signal evaluation for issues identified through pharmacovigilance or communications through Health Authorities, and author responses to regulatory inquiries as appropriate
- Contribute to regional or global product label reviews and updates as appropriate
- Collaborate with CMC and Occupational Safety to evaluate process manufacturing impurities and/or degradants and conduct risk assessments to inform mitigation strategies in accordance with regional and/or global regulatory requirements. Provide nonclinical support for occupational and environmental risk assessments
- Support the established product portfolio in line with Good Laboratory Practices (GLP), Good Clinical Practice (GCP) and relevant Standard Operating Procedures (SOPs)
- Author and review briefing books, investigator brochures, and other regulatory documents as applicable. This position will also support toxicological risk assessments associated with CMC activities
Skills
- A minimum of 10 years of experience in the pharmaceutical or biotech industry with extensive and in-depth knowledge across nonclinical disciplines in context of drug development, including toxicology, DMPK and pharmacology
- Demonstrated technical and scientific knowledge in nonclinical sciences with a particular emphasis on supporting late-stage drug development and life-cycle management
- Demonstrated knowledge of nonclinical development as well as drug substance and drug product impurity-related regulatory guidelines and GxP requirements
- Extensive experience with review and authoring nonclinical sections of regulatory dossiers (e.g., NDAs) and product labels with first-hand experience with agency interactions (meetings, briefing books and response documents)
- Experience in working in project teams (preferably global project teams)
- Exemplifies leadership qualities including effective communication and collaboration, integrity, and respectful interactions with personnel
- Excellent organizational and interpersonal skills
- Ability to process and articulate complex ideas in a manner that can be clearly communicated to less technically trained individuals
- Ability to prioritize and focus on important data and considerations to drive results and provide solution-oriented recommendations with an appropriate scientific rationale to address challenges associated with life-cycle management and CMC activities
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