Regulatory Affairs Transformation Leader

3 days ago

Hyderabad Secunderabad Telangana, India beBeeDirector Full time
Job Summary

The Regulatory Affairs Process Director will lead the transformation of end-to-end regulatory processes, ensuring efficiency, reducing complexity, and securing high-quality deliverables.

  • Contribute to the development of a comprehensive roadmap for process transformation and implementation strategy.
  • Act as a core member of the RA Process Review Committee to secure timely and impactful review, finalization, and implementation of new or revised process documents.
  • Lead impact assessments, business process design, ownership, and continuous improvement for assigned processes and/or process areas.
  • Monitor and analyze emerging regulations and regulatory guidelines, ensuring their impact on Novartis regulatory processes is assessed and actioned.
  • Lead process changes in response to compliance issues, contribute to inspections and internal audits, and provide direct input on process design, risk management, and governance.
Required Skills and Qualifications

To be successful in this role, you will need:

  • A life science degree or equivalent experience.
  • Significant regulatory and drug development experience.
  • Extensive knowledge of E2E processes, supporting systems, regulations, and business change.
  • Strong working knowledge of Quality Management Systems (QMS), SOPs, and compliance.
  • Technology-savvy skills to leverage and foster the use of systems, technology, and automation.
  • Ability to anticipate the impact of change(s) on E2E processes, supporting systems, and training.
  • Strong organizational awareness, including experience working cross-functionally.
  • Ability to lead teams in a matrix environment.
  • Superior negotiation, influencing, and communication skills.
Benefits

This role offers:

  • Opportunities for career growth and development.
  • A dynamic and supportive work environment.
  • Competitive compensation and benefits package.
Others

This position requires:

  • Ability to define and interpret metrics.
  • Strategic thinking, process simplification, and optimization.
  • Strong process authoring and writing capabilities.

Skills Desired: Clinical Trials, Cross-Functional Teams, Drug Development, Lifesciences, Negotiation Skills, People Management, Problem Solving Skills, Regulatory Compliance, Risk Management, Strategy Execution.

  • Regulatory Affairs Manager

    13 hours ago

    Hyderabad / Secunderabad, Telangana, India beBeeRegulatoryAffairs Full time ₹ 1,04,000 - ₹ 1,30,878

    Job Title: Regulatory Affairs ManagerAbout the RoleWe are seeking a highly skilled Regulatory Affairs Manager to oversee and manage the preparation, submission, and tracking of regulatory dossiers for product registrations, renewals, and variations across Asia.Key Responsibilities:Conduct thorough regulatory reviews of dossier sections (Quality) to ensure...

  • Regulatory Affairs Professional

    16 hours ago

    Hyderabad / Secunderabad, Telangana, India beBeeRegulatoryAffairs Full time ₹ 1,04,000 - ₹ 1,30,878

    Job OverviewThis role plays a critical part in the success of our organization by ensuring compliance with regulatory requirements and facilitating the efficient approval of drug products.We are seeking a highly skilled Regulatory Affairs Associate to join our team. In this position, you will be responsible for preparing generic drug product submissions for...

  • Regulatory Affairs Professional

    3 days ago

    Hyderabad / Secunderabad, Telangana, India beBeeRegulatoryAffairs Full time

    Regulatory Affairs Specialist">We are seeking a highly skilled Regulatory Affairs Specialist to join our team. As a key member of our regulatory group, you will play a critical role in ensuring compliance with regulatory requirements and facilitating the approval of our products.">Lead submission for annual reports, facility registrations, facility renewals,...

  • Global Regulatory Affairs Specialist

    3 days ago

    Hyderabad / Secunderabad, Telangana, Nizamabad, Warangal, India beBeeRegulatory Full time

    Our team seeks a strategic Regulatory Affairs Professional to join our global network. The ideal candidate will be responsible for implementing regulatory strategies and managing operational activities in assigned regions. They will provide input into global regulatory strategy, contribute to the Regulatory Functional Plan (RFP) and Seed Document, and...

  • R&d Regulatory Affairs

    1 day ago

    Hyderabad, Telangana, India PepsiCo Full time

    Overview: - This role involves supporting the Regulatory Affairs team by serving as a Discipline Approver, ensuring compliance with regulatory standards for raw material specifications. Located within the Mexico Business Services or Hyderabad Business Services, you will play a key part in maintaining adherence to regulations within the designated business...

  • Manager - Regulatory Affairs

    3 weeks ago

    Hyderabad, Telangana, India Amgen Full time

    Join Amgens Mission of Serving PatientsAt Amgen, if you feel like youre part of something bigger, its because you are. Our shared missionto serve patients living with serious illnessesdrives all that we do.Since 1980, weve helped pioneer the world of biotech in our fight against the worlds toughest diseases. With our focus on four therapeutic areas Oncology,...

  • Regulatory Excellence Leader

    3 days ago

    Hyderabad / Secunderabad, Telangana, India beBeeRegulatory Full time

    Job Title: Regulatory Excellence LeaderThis role involves leading the development and implementation of regulatory strategies for international markets, ensuring compliance with local regulations and facilitating the timely approval of our products.Key Responsibilities:Developing and executing regulatory plans to optimize product development and approval in...

  • CMC Regulatory Affairs Manager Position

    3 days ago

    Hyderabad / Secunderabad, Telangana, India beBeeRegulatory Full time

    Manage Submission Process Planning and Management for Global CMC & Device Regulatory Affairs.Key Responsibilities:Drive continuous improvement of processes and toolsEnsure awareness of processes across the organization; andShaping the training strategy across the organizationThe role will be responsible for developing, maintaining, improving, and driving...

  • Regulatory Affairs Specialist

    3 weeks ago

    Hyderabad, Telangana, India Thepharmadaily Full time

    Job Description- Collaborate and partner with Design QA, R&D, Sustaining Engineering, Clinical Affairs, Marketing, and Operations- Support the Global Operating Unit Regulatory Affairs function as the local representative, ensuring requirements are met- Provide regulatory support for research and development activities and ensure compliance with Indian and...

  • Regulatory Affairs Expert

    3 days ago

    Hyderabad, Telangana, India beBeeRegulatory Full time US$ 1,54,000 - US$ 2,41,300

    Regulatory Affairs ExpertThe Regulatory Affairs Manager is responsible for leading the execution and coordination of global regulatory activities.Key Responsibilities:Develop and execute strategic plans for global and country-specific regulatory complianceProvide CMC regulatory strategy by defining filing requirements, submission strategies, and risk...