Manager - Regulatory CMC

2 weeks ago

Gurgaon, India SUN PHARMA Full time
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.

  • Manager - regulatory cmc

    2 weeks ago

    Gurgaon, India SUN PHARMA Full time

    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...

  • Manager - Regulatory CMC

    2 weeks ago

    gurgaon, India SUN PHARMA Full time

    Job Location :Gurgaon (preferable)/Baroda/MumbaiEducation : M. PharmDepartment : Global Regulatory Affairs Specialty PharmaJob ResponsibilitiesServe as aRegulatory CMC Product Leadandprovide CMC Regulatory leadershipwithin Regulatory and on cross-functional teams for theassigned brandedbeing developed forUS and other advanced markets like EU & CanadaEnsure...

  • Manager - Regulatory CMC

    2 weeks ago

    gurgaon, India SUN PHARMA Full time

    Job Location : Gurgaon (preferable)/Baroda/MumbaiEducation : M. PharmDepartment : Global Regulatory Affairs Specialty PharmaJob 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...

  • Manager - Regulatory CMC

    2 weeks ago

    Gurgaon, India SUN PHARMA Full time

    Job Location :Gurgaon (preferable)/Baroda/MumbaiEducation : M. PharmDepartment : Global Regulatory Affairs Specialty PharmaJob ResponsibilitiesServe as aRegulatory CMC Product Leadandprovide CMC Regulatory leadershipwithin Regulatory and on cross-functional teams for theassigned brandedbeing developed forUS and other advanced markets like EU & CanadaEnsure...

  • Regulatory Affairs Expert

    2 weeks ago

    Gurgaon, Haryana, India SUN PHARMA Full time

    Job OverviewSun Pharma is seeking an experienced Regulatory Affairs Expert to lead our CMC Product team. In this role, you will be responsible for ensuring timely submission of annual reports and supplements to regulatory authorities.About the RoleWe are looking for a seasoned professional with 10-15 years of hands-on experience in regulatory affairs. You...

  • Regulatory Compliance Manager

    4 weeks ago

    Gurgaon, Haryana, India Talent Ro Full time

    Regulatory Compliance Manager Job DescriptionTalent Ro is seeking a highly skilled Regulatory Compliance Manager to lead and manage our compliance program in India. As a key member of our team, you will be responsible for ensuring that our company adheres to all applicable laws and regulations in India.Key Responsibilities:Compliance Program Management:...

  • Regulatory Compliance Project Manager

    1 month ago

    Gurgaon, Haryana, India AzimuthGRC Technologies India Private Limited Full time

    About Azimuth GRCAzimuth GRC Technologies India Private Limited is revolutionizing the world of regulatory compliance with automated compliance management technology. Our innovative solution helps companies comply with federal and state laws and ensures that every customer receives fair and equitable experiences. We are an Equal Opportunity Employer and...

  • Regulatory Compliance Project Manager

    1 month ago

    Gurgaon, Haryana, India AzimuthGRC Technologies India Private Limited Full time

    About UsAzimuth GRC Technologies is revolutionizing the world of regulatory compliance with cutting-edge technology. Our innovative solution helps companies navigate complex regulatory landscapes, ensuring fair and equitable experiences for all customers. We are an Equal Opportunity Employer and foster an inclusive, conducive, and diverse work culture. Our...

  • Assistant Manager

    2 months ago

    Gurgaon, India Takeda Full time

    Description To lead and develop Regulatory strategies for New Products, existing products and other pipeline molecules of Takeda in accordance with the applicable rules and regulations. Responsible and accountable for local regulatory activities (driven by local or corporate initiatives) and peformances in registering new products and new...

  • Regulatory Compliance Project Manager

    1 month ago

    Gurgaon, Haryana, India AzimuthGRC Technologies India Private Limited Full time

    About UsAzimuth GRC Technologies India Private Limited is a pioneering company in the field of regulatory compliance, leveraging cutting-edge technology to revolutionize the way organizations manage compliance. Our innovative solution empowers companies to navigate the complexities of federal and state laws, ensuring that every customer receives a fair and...

  • Project Manager

    1 month ago

    Gurgaon, Haryana, India AzimuthGRC Technologies India Private Limited Full time

    Job DescriptionAzimuth GRC is a leading provider of regulatory compliance management solutions. We are seeking a highly skilled Project Manager - Regulatory Compliance Management to join our team.About the RoleThe successful candidate will be responsible for overseeing and coordinating regulatory compliance projects, ensuring that all activities align with...

  • Regulatory Counsel

    1 month ago

    Gurgaon, Haryana, India Boston Consulting Group Full time

    Job OverviewWe are seeking a highly skilled Regulatory Counsel to join our team at Boston Consulting Group. As a key member of our Global Legal Team, you will play a critical role in driving compliance and regulatory excellence across our organization.Key ResponsibilitiesThe successful candidate will be responsible for:Providing expert advice on regulatory...

  • Sr. Manager Regulatory Compliance

    2 weeks ago

    gurgaon, India airtel Full time

    Overview: This is a pivotal role responsible for overseeing and ensuring company’s compliance with regulatory landscape. This position requires a unique blend of legal expertise, regulatory acumen, and strong leadership capabilities to navigate complex environments and foster relationships with diverse stakeholders. Key Responsibilities: Regulatory...

  • Sr. Manager Regulatory Compliance

    2 weeks ago

    gurgaon, India airtel Full time

    Overview:This is a pivotal role responsible for overseeing and ensuring company’s compliance with regulatory landscape. This position requires a unique blend of legal expertise, regulatory acumen, and strong leadership capabilities to navigate complex environments and foster relationships with diverse stakeholders.Key Responsibilities:Regulatory Compliance...

  • Compliance and Regulatory Affairs Manager

    3 weeks ago

    Gurgaon, Haryana, India Stryker Global Technology Center Pvt Ltd. Full time

    About the Role:We are seeking a highly skilled Compliance and Regulatory Affairs Manager to join our R&D Operations team at Stryker Global Technology Center Pvt Ltd.As a key member of our team, you will be responsible for leading compliance processes and ensuring our R&D operations meet all relevant regulatory requirements.Key Responsibilities:Develop and...

  • Regulatory Affairs Specialist

    2 weeks ago

    gurgaon, India Naari Pharma Pvt Ltd. Full time

    Who You Are: You are skilled professional with deep understanding of regulatory frameworks and have a proven track record of managing the entire regulatory life cycle independently. Your ability to manage projects end-to-end makes you a valued contributor in achieving product approvals. How You Contribute Manage the full life cycle of regulatory...

  • Regulatory Manager and R&D Professional

    4 weeks ago

    Gurgaon, Haryana, India Glanbia Full time

    The OpportunityWe are seeking a highly skilled R&D and Regulatory Manager to lead the development of new health supplement products for the Indian market.You will be responsible for the entire product development lifecycle, from market research and concept generation to product launch and post-launch monitoring.This exciting role offers the opportunity to...

  • Regulatory Affairs Specialist

    2 weeks ago

    Gurgaon, India Naari Pharma Pvt Ltd. Full time

    Who You Are:You are skilled professional with deep understanding of regulatory frameworks and have a proven track record of managing the entire regulatory life cycle independently. Your ability to manage projects end-to-end makes you a valued contributor in achieving product approvals.How You Contribute1. Manage the full life cycle of regulatory submissions...

  • Regulatory Affairs Specialist

    2 weeks ago

    gurgaon, India Naari Pharma Pvt Ltd. Full time

    Who You Are:You are skilled professional with deep understanding of regulatory frameworks and have a proven track record of managing the entire regulatory life cycle independently. Your ability to manage projects end-to-end makes you a valued contributor in achieving product approvals.How You ContributeManage the full life cycle of regulatory submissions for...

  • Regulatory Affairs Specialist

    2 weeks ago

    gurgaon, India Naari Pharma Pvt Ltd. Full time

    Who You Are:You are skilled professional with deep understanding of regulatory frameworks and have a proven track record of managing the entire regulatory life cycle independently. Your ability to manage projects end-to-end makes you a valued contributor in achieving product approvals.How You ContributeManage the full life cycle of regulatory submissions for...