• Strong experience in CMC requirements for small molecule/biologic products.
• Proven experience in critically reviewing detailed scientific information to assess technical merits and suitability of scientific rationale to ensure information is 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.
• Ability to lead a team of direct or matrixed colleagues to deliver on business commitments and project timelines.
Desired Education
Bachelor's degree required in science, engineering or related field (advanced degree preferred)
Desired Experience
At least seven (7) years of relevant industry experience to include regulatory affairs, research; manufacturing, testing, or licensure of pharmaceutical, vaccine, or biological products; or related fields.
Must haves:
CMC experience :CMC 3, 7 years.
Post approval regulatory CMC experience, at least 5 years
Device/Instrument experience
Comfortable working independently