Director of Regulatory Strategy

21 hours ago

Hyderabad, Telangana, India beBeeRegulatoryAffairs Full time ₹ 15,00,000 - ₹ 25,00,000

Job Summary:

We are seeking a highly skilled and experienced Regulatory Affairs Director to join our team. As a key member of our organization, you will be responsible for formulating and leading global regulatory strategies that drive innovation and maximize business benefits while ensuring regulatory compliance.

The ideal candidate will have a deep understanding of regulatory activities related to chemistry, manufacturing, and control (CMC) and will be able to lead and implement all global CMC submission activities, including planning, authoring, reviewing, coordination, and submission. You will also identify required documentation and negotiate the delivery of approved technical source documents in accordance with project timelines.

Main Responsibilities:

  • Develop and execute global regulatory strategies that align with business objectives
  • Lead and implement all global CMC submission activities
  • Identify and manage risks associated with regulatory submissions
  • Negotiate with stakeholders to ensure timely delivery of approved technical source documents
  • Ensure regulatory compliance and accuracy in all submission documentation

Required Skills and Qualifications:

  • Deep understanding of regulatory activities related to CMC
  • Strong leadership and project management skills
  • Excellent communication and negotiation skills
  • Ability to work effectively in a fast-paced environment
  • Proven track record of success in regulatory affairs

Benefits:

  • Opportunity to work on high-impact projects that drive business growth
  • Collaborative and dynamic work environment
  • Competitive salary and benefits package
  • Professional development opportunities

Others:

  • Novartis is committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve
  • Join our Novartis Network to stay connected and hear more about our career opportunities

  • Director of Regulatory Research

    4 weeks ago

    Hyderabad, Telangana, India Kamet Consulting Group Full time

    Job Title: Director of Regulatory Research & IntelligenceLocation: Hybrid (Hyderabad)Industry: Life Sciences / Healthcare TechnologyExperience Level: 10+ yearsEmployment Type: Full-timeAbout the RoleKamet Consulting Group is seeking a high-impact Director to lead our Global Regulatory Research & Intelligence function while driving strategic business...

  • Director of Regulatory Research

    1 week ago

    Hyderabad, Telangana, India Kamet Consulting Group Full time

    Job Title: Director of Regulatory Research & Intelligence Location: Hybrid (Hyderabad) Industry: Life Sciences / Healthcare Technology Experience Level: 10+ years Employment Type: Full-time About the Role Kamet Consulting Group is seeking a high-impact Director to lead our Global Regulatory Research & Intelligence function while driving strategic...

  • Director of Regulatory Research

    2 weeks ago

    Hyderabad, Telangana, India Kamet Consulting Group Full time

    Job Title: Director of Regulatory Research & IntelligenceLocation: Hybrid (Hyderabad)Industry: Life Sciences / Healthcare TechnologyExperience Level: 10+ yearsEmployment Type: Full-timeAbout the RoleKamet Consulting Group is seeking a high-impact Director to lead our Global Regulatory Research & Intelligence function while driving strategic business...

  • Global Regulatory Strategy Manager

    3 hours ago

    Hyderabad, Telangana, India beBeeRegulatory Full time ₹ 1,50,00,000 - ₹ 2,50,00,000

    Key AccountabilitiesAs a seasoned regulatory professional, your primary responsibilities will involve developing and implementing global regulatory strategies to ensure timely submissions and approvals. You will collaborate closely with regional teams to align on regulatory approaches and facilitate the submission of dossiers worldwide.Main...

  • CMC Regulatory Strategy Lead

    13 hours ago

    Hyderabad, Telangana, India beBeeregulatory Full time ₹ 1,00,00,000 - ₹ 2,00,00,000

    Job Overview:We are seeking a seasoned Regulatory CMC Manager to lead our global regulatory strategy and ensure compliance with all relevant regulations.Key Responsibilities:Develop and implement global CMC regulatory strategies, balancing business benefits with regulatory compliance.Lead global CMC submission activities, including planning, authoring,...

  • Marketing Strategy Director

    7 hours ago

    Hyderabad, Telangana, India beBeeStrategy Full time ₹ 20,00,000 - ₹ 25,00,000

    ">Marketing Strategy DirectorWe are seeking a seasoned Marketing Manager/Senior Marketing Manager to lead business development activities across India in coordination with Senior Management and Sales Heads.Job ResponsibilitiesDevelop and execute comprehensive marketing strategies to drive business growthTake ownership of branding, communications, and...

  • Director of Content Strategy

    3 hours ago

    Hyderabad, Telangana, India beBeeMarketing Full time US$ 2,00,000 - US$ 2,50,000

    Job OpportunityThe Associate Director will work in collaboration with a cross-functional team to develop effective content and concepts for projects and campaigns.Interpret business needs around content and messaging to produce results tailored to client requirements;Collaborate with marketing teams to create messaging, sourcing credible information to craft...

  • Director, Regulatory Affairs

    1 day ago

    Hyderabad, Telangana, India Novartis Full time

    Job Description Summary -Responsible for regulatory activities specifically related to chemistry, manufacturing, and control (CMC) . Formulate and lead global CMC regulatory strategy with a focus on innovation, maximizing the business benefit balanced with regulatory compliance -Lead and implement all global CMC submission activities (planning, authoring,...

  • Global Regulatory Strategy Leader

    3 hours ago

    Hyderabad, Telangana, India beBeeRegulatory Full time ₹ 80,00,000 - ₹ 1,50,00,000

    Job Title:Strategic Regulatory ManagerKey Responsibilities:Develop and implement global regulatory strategies across multiple regionsCollaborate with regional teams to align on strategic objectives and contribute to business outcomesEstablish requirements and set goals for Health Authority interactionsFacilitate the preparation and finalization of briefing...

  • Global CMC Regulatory Strategy Manager

    4 days ago

    Hyderabad, Telangana, India beBeeRegulatory Full time ₹ 1,80,96,000 - ₹ 2,21,92,000

    Job Title:A Manager is required to lead global CMC regulatory strategy.The ideal candidate will formulate and implement a proactive approach to maximize business benefit balanced with regulatory compliance.Liaise with cross-functional teams to ensure technical congruency and regulatory compliance.Prepare and communicate CMC Risk Management Assessments,...