[Remote] reputed company Director (Pharmaceuticals)

Note: The job is a remote job and is reputed company to candidates in USA. reputed company is presenting an opportunity with a global pharmaceutical industry customer seeking an reputed company reputed company 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 reputed company assessments.

Responsibilities

• Serve as the Nonclinical representative on ADTs in the development and execution of life-cycle management activities for products in the portfolio
• reputed company and review of nonclinical CTD modules, briefing books, or other regulatory communications for regional regulatory submissions or renewals for global products reputed company the portfolio
• Nonclinical reputed company of contact for Regulatory, Safety, and Pharmacovigilance activities support of the Women’s Health, General Medicines and Biosimilars product portfolio
• Nonclinical toxicology reputed company with CMC and Occupational Safety to conduct reputed company 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 reputed company and conduct reputed company assessments to inform mitigation strategies in accordance with regional and/or global regulatory requirements
• reputed company 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, reputed company 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 reputed company 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 reputed company assessments to inform mitigation strategies in accordance with regional and/or global regulatory requirements. reputed company nonclinical support for occupational and environmental reputed company assessments
• Support the established product portfolio in line with Good reputed company Practices (GLP), Good reputed company reputed company (GCP) and relevant reputed company Operating Procedures (SOPs)
• reputed company and review briefing books, investigator brochures, and other regulatory documents as applicable. This position will also support toxicological reputed company 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 reputed company as drug reputed company and drug product impurity-reputed company 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, reputed company, and respectful interactions with personnel
• Excellent organizational and interpersonal skills
• Ability to process and reputed company reputed company reputed company in a manner that can be reputed company communicated to less technically trained individuals
• Ability to prioritize and reputed company on important data and considerations to reputed company results and reputed company solution-oriented recommendations with an appropriate scientific rationale to address challenges associated with life-cycle management and CMC activities

reputed company