Strategic Regulatory Affairs Director

3 days ago

Gurgaon, Haryana, India beBeeRegulatory Full time ₹ 1,50,00,000 - ₹ 2,20,00,000
Job Title: Strategic Regulatory Affairs Director

About the Role:
The Global Regulatory Lead will be responsible for formulating, developing, and executing a comprehensive regulatory strategy integrating US and ex-US regulatory requirements and health authority engagements to drive product development, global registration, and ultimately desired labeling for one or more assets within or across therapeutic areas. This role will also act as a US agent.

Responsibilities:
  • Provide strategic, tactical, and operational direction and guidance to product teams for assigned inline and/or pipeline assets in one or more therapeutic areas.
  • Develop, socialize, execute, and maintain the regulatory commitments and requirements for assigned assets.
  • Retrain contemporary knowledge of regulations, directives, guidelines, and policies that may have an impact on product development to assess approval pathways and associated risks.
  • Identify and communicate issues to management related to product development that could impact effective regulatory execution.
  • Set and monitor submission timelines along with other key stakeholders.
  • In association with other regulatory leaders, facilitate and lead communications with health and/or competent authorities where applicable.
  • Ensure compliance with established procedure within the department.
  • Must be involved in writing or to facilitate the authoring of certain sections of product submissions dossiers.
  • Develops and manages relationships with external regulatory agencies, industry groups, and business partners.
  • As applicable, shall review the audit reports, Regulatory Agency inspection reports, and responses to the inspection observations if any when received.
  • Compiles, prepares, and reviews regulatory submissions to regulatory agencies as applicable may be the US agent for selected assets.
  • Conduct department-level training, as necessary, to educate regulatory strategists and other roles in the department on regulatory requirements, policies, and procedures.
  • Participate in authoring and/or reviewing of the departmental procedure as applicable.

Qualifications:
  • Advanced degree preferred (PhD, MD, PharmD, MBA, JD).
  • Minimum of 10 years of experience within global regulatory affairs in the pharmaceutical or biotech industries.
  • A thorough understanding of drug development process and regulatory requirements for product development across modalities and disease areas.
  • Direct experience authoring and filing clinical trial or marketing applications across major regulated markets and a knowledge of the developing biologics regulations.

  • Regulatory Affairs Lead

    6 days ago

    Gurgaon, Haryana, India beBeeRegulatoryAffairsManager Full time ₹ 1,04,000 - ₹ 1,30,878

    Job Title: Senior Regulatory Affairs ManagerThe role of the Senior Regulatory Affairs Manager is to serve as a high-level expert in regulatory affairs, overseeing the development and implementation of regulatory strategies for products. This includes interacting with regulatory agencies to expedite approval, serving as a liaison throughout the product...

  • Medtronic - Director - Quality Assurance & Regulatory Affairs

    4 hours ago

    Gurgaon, Haryana, India Medtronic (Medtronic)(279) Full time

    At Medtronic you can begin a life-long career of exploration and innovation, while helping champion healthcare access and equity for all. Youll lead with purpose, breaking down barriers to innovation in a more connected, compassionate world.A Day in the Life.Role Summary. The QARA Director for India will be responsible for leading a team supporting Quality...

  • Regulatory Affairs Expert

    3 days ago

    Gurgaon, Haryana, India beBeeRegulatoryAffairs Full time ₹ 18,00,000 - ₹ 24,00,000

    Job DescriptionWe are seeking an experienced Regulatory Affairs expert to lead product registration submissions and reports. This role requires comprehensive knowledge of regulatory affairs, with the ability to manage complex projects.Key ResponsibilitiesLiaise with regulatory agencies for approval and compliance.Provide regulatory guidance during product...

  • Regulatory Affairs Coordinator

    1 week ago

    Gurgaon, Haryana, India beBeeRegulatory Full time ₹ 10,00,000 - ₹ 15,00,000

    Regulatory Affairs CoordinatorJob Summary:As a Regulatory Affairs Coordinator, you will be responsible for developing and implementing processes to ensure compliance with regulatory requirements at the district and state level.This includes tracking and establishing procedures for PC&PNDT regulations and AERB regulations for medical devices.You will work...

  • Regulatory Affairs Specialist

    3 days ago

    Gurgaon, Haryana, India beBeeRegulatory Full time ₹ 15,00,000 - ₹ 22,50,000

    Regulatory Affairs SpecialistAbout the Role:We are seeking a skilled Regulatory Affairs Specialist to join our team. As a key member of our regulatory team, you will be responsible for ensuring that our products comply with relevant regulations and guidelines.Key Responsibilities:Support the product lifecycle through obsolescence by assessing changes made to...

  • Project Manager – Regulatory Affairs

    5 days ago

    Gurgaon, Haryana, India DDReg Pharma Pvt. Ltd. Full time US$ 90,000 - US$ 1,20,000 per year

    Job SummaryWe are seeking an experienced and highly motivated Project Manager (Regulatory Affairs) to lead and manage regulatory projects from initiation to completion, ensuring timely and successful product registration, market authorization, and compliance with relevant regulatory requirements. The ideal candidate will have a deep understanding of global...

  • Regulatory Affairs Specialist

    7 days ago

    Gurgaon, Haryana, India beBeeRegulatory Full time ₹ 50,00,000 - ₹ 75,00,000

    Regulatory Affairs PositionWe are seeking a highly motivated individual to fill the role of Regulatory Affairs Specialist. The ideal candidate will be responsible for tracking and establishing processes related to PC& PNDT and AERB regulations at the District / State level.Key Responsibilities:Process Tracking and Establishment: Track and establish process...

  • Expert Regulatory Affairs Leader

    7 days ago

    Gurgaon, Haryana, India beBeeRegulatory Full time ₹ 20,00,000 - ₹ 30,00,000

    Senior Regulatory Affairs Manager RoleThis is a key leadership position that requires strong expertise in Regulatory Affairs.Job Responsibilities:Lead the development of product registration submissions, progress reports, and periodic experience reports.Engage with regulatory agencies to expedite approval of pending registrations and ensure compliance with...

  • Regulatory Affairs

    2 days ago

    Gurgaon, Haryana, India Sun Pharma Full time ₹ 15,00,000 - ₹ 28,00,000 per year

    Area Of ResponsibilityTo review quality and manufacturing end data for various in-house developed APIs for regulatory adequacy for compilation of Drug Master Files/Registration Dossiers, Amendments/Variations, Technical Data Package/Open Parts of DMFs for In-House developed APIs and their updation to meet current regulatory requirements.To review outsourced...

  • Corporate Affairs Director

    5 days ago

    Gurgaon, Haryana, India Mars Full time ₹ 15,00,000 - ₹ 20,00,000 per year

    Job DescriptionMars has been committed to India and has been investing in our growing our India business for several decades, with a strong local talent pool. Today, there are over 1,000 Associates across our segments - Mars Petcare, Royal Canin, Mars Wrigley and Mars Food. Our Make in India commitment is further enhanced by the 5 factories that we operate...