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Job Profile
Serve as a Regulatory CMC Product Lead and provide CMC Regulatory leadership within Regulatory and on cross-functional teams for the assigned branded products 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 especially for Injectables (Parenteral) formulations 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 strategy 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.
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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.
Set and monitor submission timelines along with other key stakeholders
Coordination with global manufacturing sites and integration of regulatory strategy with those sites
Provide consistent support to cross-functional teams like; commercial and clinical teams
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 quires, communication with agencies for developed markets like US/EU and global emerging countries
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., sterile manufacturing process, aesthetic quality, sterility testing, 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.
CompetenciesRequired:
At least fifteen (15) years of hands-on experience in global regulatory affairs for Injectables (Parenteral) formulations.
The 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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Job Requirements
Educational Qualification –
Advanced degree preferred (PhD, PharmD, MBA, M-Pharm in pharmaceutical sciences)
Experience –
Tenure: 15 + years
Your Success Matters to Us
At Sun Pharma, your success and well-being are our top priorities! We provide robust benefits and opportunities to foster personal and professional growth. Join us at Sun Pharma, where every day is an opportunity to grow, collaborate, and make a lasting impact. Let’s create a brighter future together!
Disclaimer: The preceding job description has been designed to indicate the general nature and level of work performed by employee within this classification. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities, and qualifications required of employees as assigned to this job. Nothing herein shall preclude the employer from changing these duties from time to time and assigning comparable duties or other duties commensurate with the experience and background of incumbent(s).
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