Manager - Regulatory CMC

2 weeks ago

gurgaon, India SUN PHARMA Full time
Job Location :
Gurgaon (preferable)/Baroda/MumbaiEducation : M. PharmDepartment : Global Regulatory Affairs Specialty Pharma
Job ResponsibilitiesServe 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 & CanadaEnsure lifecycle management through timely submission of annual reports, supplements etc to ensure product continuityThe 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/EUProven 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 affairsThis 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 membersThe candidate must be proficient in English; additional language skills are a plus.Good inter-personnel skills with ability to direct multi-departmental functions.

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