Associate Director, Regulatory Affairs CMC - United States
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- Our company is a global health care leader with a diversified portfolio of prescription medicines, vaccines and animal health products.
- The difference between potential and achievement lies in the spark that fuels innovation and inventiveness; this is the space where company has codified its 125-year legacy.
- Our company's success is backed by ethical integrity, forward momentum, and an inspiring mission to achieve new milestones in global healthcare.
- Our company’s Regulatory Affairs organization helps bring new medical advancements to the world by facilitating the communications and procedures that allow swift, organized compliance across regulatory agencies.
- As a team of energetic, results-driven individuals, we’re a global network on the leading-edge of healthcare breakthroughs that help provide new, reliable, and compliant medical products, practices, and solutions to the world on time, every time.
- Reporting to the Director, the Associate Director in Pre-approval Pharmaceutical CMC is responsible for developing and implementing CMC regulatory strategies for company's pharmaceutical pipeline products in accordance with global regulations and guidance, and is responsible for the preparation and submission of CMC dossiers for all assigned development products.
- Serve as a CMC Product Lead for assigned products and be accountable for the delivery of all regulatory milestones through product development including assessment of the probability of regulatory success together with risk mitigation measures.
- Lead development and execution of global product and project regulatory strategy(ies) by ensuring robust assessment of global regulatory CMC requirements and critical evaluation of supporting documentation to confirm acceptability and identification of potential risks.
- Lead the development, communication, lifecycle management and review of the CMC Regulatory Strategy Document for assigned projects.
- Provide regulatory leadership as needed in product in-license/due diligence review and product transition to the Post-Approval Pharm CMC team.
- Manage execution of CMC documentation including IND/CTA, original NDA/MAA, agency background packages and responses to health authority questions per established business processes and systems.
- Identify, communicate and escalate potential regulatory issues to GRACS CMC management, as needed
- Demonstrate an understanding of regulatory affairs and apply this understanding to the benefit of the company to ensure the approval and launch market supply of company pharmaceutical products worldwide.
- Conduct all activities with an unwavering focus on compliance
- B.S. in a biological science, engineering, or a related field (advanced degree preferred).
- Fields of study include Pharmacy, Chemical Engineering, Biology, Microbiology, or Biochemistry
- At least five (5) years of relevant experience, including biological/pharmaceutical research; manufacturing, testing, or regulatory CMC; or related fields.
- The candidate must be proficient in English; additional language skills are a plus.
- Proven experience in critically reviewing detailed scientific information and assessing whether technical arguments are presented clearly and conclusions are adequately supported by data.
- Demonstrated superior oral and written communication skills in multicultural settings and ability to communicate complex issues in a succinct and logical manner. Strong listening skills.
- Demonstrated sound understanding of related fields (e.g., manufacturing, analytical, quality assurance) and the ability to be creative and imaginative in the approach to new and diverse problem solving.
- Demonstrated ability to generate innovative solutions to complex regulatory problems and effectively work with and communicate to key stakeholders.
- Demonstrated flexibility in responding to changing priorities or dealing with unexpected events.
- Demonstrated effective leadership, communication, interpersonal and negotiating skills.
Travel: Yes, 10 % of the Time
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