Manager Regulatory CMC

• Serve as a Regulatory CMC Product Lead and provide CMC Regulatory leadership within Regulatory and on cross-functional teams for the assigned branded being developed for US and other advanced markets like EU & Canada
• Ensure lifecycle management through timely submission of annual reports, supplements etc to ensure product continuity
• The CMC Product Lead is accountable for the delivery of all regulatory milestones for higher complexity products in which responsible including assessment of the probability of regulatory success together with risk mitigation measures.
• Lead the development, communication, and review of the CMC Regulatory Strategy Document for projects of increasing complexity.
• Provide regulatory leadership as needed in product in-license/due diligence review, product divestment and product withdrawal.
• Manage execution of CMC documentation including PIND/IND/CTA, original NDA/MAA, agency background packages and responses to health authority questions per established business processes and systems.

• 10-15 years of hands-on experience in regulatory affairs
• This role needs a seasoned professional who is aware of the regulatory activities for NDAs, can work in R & D CFT and who has the management capability of leading a group of team members
• Hands of expertise of preparation & review of dossiers, response to queries, communication with agencies for developed markets like US/EU
• Proven experience in critically reviewing detailed scientific information and assessing whether technical arguments are presented clearly and conclusions are adequately supported by data.
• 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 superior oral and written communication skills in multicultural settings and ability to communicate complex issues in a succinct and logical manner. Strong listening skills.

M-Pharm in pharmaceutical sciences