Dgm/sm - Regulatory Affairs - Cmc - Branded

Job Title Sr Manager DGM Business Unit Sun Global Operations Job Grade G9A G8 Location Gurgaon At Sun Pharma we commit to helping you Create your own sunshine - by fostering an environment where you grow at every step take charge of your journey and thrive in a supportive community Are You Ready to Create Your Own Sunshine As you enter the Sun Pharma world you ll find yourself becoming Better every day through continuous progress Exhibit self-drive as you Take charge and lead with confidence Additionally demonstrate a collaborative spirit knowing that we Thrive together and support each other s journeys Key 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 CA 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 15 - 18 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 Travel Estimate Job Requirements Educational Qualification M Sc B Pharm M Pharm Experience Tenure 15 to 18 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