Senior Regulatory Professional

3 days ago

Bengaluru, Karnataka, India beBeeRegulatoryExpertise Full time ₹ 1,50,00,000 - ₹ 2,50,00,000
Job Description">

Work with a team of innovators who are passionate about science and technology to enrich people's lives.

">

We are looking for individuals who can provide end-to-end support for Annual Reports and Renewals, planning required activities, attending kick-off meetings, contributing to DSP, and ensuring timely collection of requirements and deliverables.

">

The role involves managing and responsible CMC Regulatory activities and projects, including answering Health Authority queries, life cycle management submissions, and marketing authorization applications.

">

As a Senior Specialist in Regulatory Affairs, you will be accountable for providing country-specific CMC regulatory requirements for dossier strategies and plans.

">

You will also review study protocols and reports to confirm alignment with the CMC Dossier Strategy and Plan, and identify gaps, issues, risks, and mitigation measures.

">

Responsibilities:

">
  • ">
  • Manage assigned CMC Regulatory activities and projects, including coordinating local CMC variations.">
  • Conduct change control regulatory assessment for multiproduct site changes, updating the CCP tracker, and performing notifications.">
  • Develop and prepare successful regulatory CMC strategies and CMC dossiers.">
  • Prepare and manage regulatory CMC documentation, including full international submissions or complex variations.">
  • Collaborate with cross-functional teams to achieve project goals and objectives.">
">

Required Skills and Qualifications">

We are seeking individuals with a strong background in Pharmacy or Life Science, Medical, PharmD, or related disciplines. A minimum of 7+ years of overall work experience in a Pharma environment, competent authority, or academia/R&D experience related to the role is preferred.

">

Candidates should possess excellent written and spoken English language skills, as well as strong project management and documentation skills.

">

They should also have in-depth knowledge of global pharmaceutical legislation, specifically linked to regulatory CMC aspects in ICH countries, and experience working in a global regulatory environment.

">

Benefits">

Our organization offers a dynamic and inclusive work environment that values diversity and promotes growth and development opportunities.

">

As a Senior Specialist in Regulatory Affairs, you will be part of a team that is passionate about caring for our rich mix of people, customers, patients, and planet.

">

Our company encourages active networking within and beyond disciplines/areas, projects, and reaches out to international colleagues to play an active role in the international expert community.

">

Others">

Join us in building a culture of inclusion and belonging that impacts millions and empowers everyone to work their magic and champion human progress.

">

Apply now and become a part of our diverse team

"]],

  • Regulatory Oversight Professional

    5 days ago

    Bengaluru, Karnataka, India beBeeRegulatory Full time ₹ 1,50,00,000 - ₹ 2,50,00,000

    Job Description:We are seeking a skilled Regulatory Oversight Professional to join our dynamic and global team. This is an exciting opportunity to work in a leading financial services institution.Main Responsibilities:Manage and coordinate regulatory examinations, including logging information requests, preparing decks, reviewing responses, and more.Oversee...

  • Senior Regulatory Advisor

    2 weeks ago

    Bengaluru, Karnataka, India beBeeRegulatory Full time ₹ 2,40,00,000 - ₹ 3,00,00,000

    We are seeking an exceptional professional to fill the role of Senior Regulatory Advisor. As a key member of our Financial Services team, you will play a vital part in shaping regulatory strategies for clients across various industries.

  • Senior Regulatory Compliance Professional

    7 days ago

    Bengaluru, Karnataka, India beBeeCompliance Full time ₹ 1,20,00,000 - ₹ 1,80,00,000

    Regulatory Affairs SpecialistAs a Regulatory Affairs Specialist, you will play a pivotal role in ensuring the compliance of medical devices with regulatory frameworks. Your responsibilities will span across various aspects of device development and post-market surveillance.">Develop and maintain technical documentation and declarations of conformity for...

  • Regulatory Compliance Professional

    3 days ago

    Bengaluru, Karnataka, India beBeeCompliance Full time ₹ 5,00,000 - ₹ 8,00,000

    We're seeking an experienced Regulatory Compliance Manager to join our team. The ideal candidate will have a strong background in Quality and Compliance managed services, with experience in Computer System Validation and Stakeholder Management.This is a fantastic opportunity to be part of a leading firm whilst being instrumental in the growth of emerging...

  • Regulatory Compliance Professional

    2 days ago

    Bengaluru, Karnataka, India beBeeRegulatory Full time ₹ 4,00,000 - ₹ 8,00,000

    Job Summary:We are seeking a highly skilled Regulatory Compliance Senior to join our team. In this role, you will be responsible for ensuring compliance with industry regulations and standards.Job DescriptionThe Regulatory Compliance Senior will work closely with business stakeholders, laboratory personnel, and IT teams to gather and document LIMS...

  • Senior Regulatory Specialist

    6 days ago

    Bengaluru, Karnataka, India beBeeRegulatory Full time ₹ 20,00,000 - ₹ 25,00,000

    Job Description:We are seeking an experienced Regulatory Affairs professional to join our team. As a Senior Associate, you will play a key role in ensuring the conformity of our SaMD products with regulatory requirements.The successful candidate will have excellent communication and analytical skills, with the ability to work independently and as part of a...

  • Regulatory Affairs Professional

    2 weeks ago

    Bengaluru, Karnataka, India beBeeRegulatory Full time

    Regulatory Affairs ProfessionalThe ideal candidate will be responsible for working closely with international regulatory teams to ensure compliance with Indian regulations.Develop and maintain in-depth knowledge of India's Medical Device Regulations (MDR).Collaborate with cross-functional teams to implement effective regulatory strategies.Identify and...

  • Senior Regulatory Compliance Specialist

    2 weeks ago

    Bengaluru, Karnataka, India beBeeCompliance Full time US$ 90,000 - US$ 1,20,000

    Job Title: Compliance Analyst SeniorWe are seeking a highly skilled and experienced Compliance Analyst Senior to join our team. As a key member of our compliance function, you will play a critical role in ensuring that our products and services meet the highest standards of regulatory compliance.About the JobThis is an exciting opportunity for a senior-level...

  • Senior Regulatory Compliance Specialist

    1 week ago

    Bengaluru, Karnataka, India beBeeCompliance Full time ₹ 18,00,000 - ₹ 21,00,000

    Job SummaryWe are seeking a highly skilled Senior Regulatory Compliance Specialist to join our team. As a key member of our Regulatory Reporting Team, you will play a vital role in ensuring compliance with various regional regulations in the OTC Derivatives domain.This is an excellent opportunity for experienced professionals to take on new challenges and...

  • Senior Regulatory Affairs Expert

    6 days ago

    Bengaluru, Karnataka, India beBeeRegulatory Full time ₹ 30,00,000 - ₹ 40,00,000

    Regulatory Affairs Specialist OpportunityA leading global medical technology company seeks a seasoned Regulatory Affairs specialist to drive their regulatory vision and strategy.About the RoleWe are looking for a highly experienced Regulatory Affairs professional to lead our regulatory team, develop strategic plans, and ensure compliance with regulatory...