Title:  Manager Regulatory CMC

Position: Manager

Grade: G10

Job Location: Gurgaon (preferable)/Baroda/Mumbai

Education: M. Pharm

Department: Global Regulatory Affairs Specialty Pharma

Job Responsibilities

• 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.
• Support new technology development within our Company.
• Demonstrate an understanding of regulatory affairs and applies this understanding to the benefit of the company to ensure the approval and continued market supply of our Branded products worldwide.
• Conduct all activities with an unwavering focus on compliance.
• May need to manage or mentor junior team members.

Technical Skills:

• 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 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.

Leadership Skills:

• 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.

Education Minimum Requirement:  M-Pharm in pharmaceutical sciences

Required Experience and Skills:

• 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
• The candidate must be proficient in English; additional language skills are a plus.
• Good inter-personnel skills with ability to direct multi-departmental functions.