Regulatory Compliance Manager

7 days ago

Bengaluru, Karnataka, India beBeeGxp Full time US$ 9,00,000 - US$ 12,00,000

Job Title: GxP Compliance Manager

You will be responsible for ensuring that IT applications comply with regulatory requirements. This involves actively contributing to project management initiatives, integrating technology with business process transformation programs, and performing gap assessments and remediation procedures.

Main Responsibilities:

  • Validate IT applications against GAMP Life Cycle Approach
  • Integrate technology with business process transformation programs like SAP, LIMS, ELN, MES, Documentum, TrackWise, Veeva Vault, ValGenesis, Argus, Regulatory Information Management System etc.
  • Perform software classification, IT risk assessment and mitigation strategies for IT applications.
  • Provide guidance and share knowledge on complex issues in a regulatory environment.
  • Work with clients to create plans for accomplishing engagement objectives and a strategy that complies with professional standards.
  • Assist senior managers in driving business development on existing client engagements by associating with clients and executing deliverables in an efficient manner.
  • Identify opportunities in existing accounts to cross-sell other services.
  • Plan and monitor project deliverables from the team.
  • Create innovative insights for clients and contribute to thought leadership documents.
  • Demonstrate teamwork by working with cross-functional teams across service lines in completing deliverables within timelines.
  • Maintain a strong client focus by effectively serving client needs and developing productive working relationships.
  • Regularly report status to senior managers, partners, directors, and onsite coordinators.
  • Contribute to improving operational efficiency on projects and internal initiatives.

Required Skills and Qualifications:

  • Quality and compliance managed services and consulting experience in the life sciences domain.
  • Experience in executing validation deliverables in software implementation projects.
  • Strong knowledge of regulations such as USFDA, WHO, HIPAA, TGA, MCC, Anvisa etc.
  • Versed with ICH guidelines, ISPE framework on risk management, system development life cycle concepts.
  • Strong knowledge on enterprise IT applications like LIMS, SAP, ELN, MES, Documentum, TrackWise, Veeva Vault, ValGenesis, Argus, Regulatory Information Management System etc.
  • Versed with SOP documentation, analyzing work instructions, user manuals.
  • Strong knowledge of quality system elements such as deviation, CAPA, and change controls.
  • Strong understanding of data integrity requirements.
  • Governance and reporting.
  • Knowledge of incident management, change management, periodic review, vendor management, quality management review procedures.

Benefits:

  • A challenging role with opportunities for growth and development.
  • A collaborative work environment with a team of experienced professionals.
  • The opportunity to work on high-profile projects and engage with clients globally.

Others:

  • Bachelor's degree in electronics, computer science, or related field with 10-12 years of experience in Big 4 or multi-national regulatory compliance companies.
  • Good interpersonal skills; good written and presentational skills.
  • At managerial positions within information technology (IT) and/or quality assurance (QA) for major organizations.
  • Experience in managing teams and solution designing.

  • Expertise in Regulatory Compliance

    2 weeks ago

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

    Regulatory Compliance ExpertWe are seeking a highly skilled Regulatory Compliance Expert to ensure our products meet all regulatory, safety, and certification requirements.Monitor and manage evolving regulatory standards.Build and maintain relationships with internal subject matter experts and external advisors.Integrate compliance requirements into product...

  • Regulatory Compliance Specialist

    2 weeks ago

    Bengaluru, Karnataka, India beBeeCompliance Full time ₹ 1,04,000 - ₹ 1,30,878

    Job DescriptionOur organization seeks a skilled professional to oversee the implementation of compliance frameworks and regulatory controls.Support the execution of compliance frameworks and ensure adherence to regulatory requirements.Conduct thorough compliance checks and collaborate with internal teams to identify areas for improvement.Ensure timely...

  • Regulatory Compliance Specialist

    1 week ago

    Bengaluru, Karnataka, India beBeeCompliance Full time ₹ 9,00,000 - ₹ 12,00,000

    Job Title: Regulatory Compliance SpecialistAbout the Role:The Regulatory Compliance Specialist plays a pivotal role in supporting clients in ensuring adherence to regulatory standards. This position is responsible for managing and analyzing supplier documentation, preparing audits and reports, maintaining program compliance summaries, providing expert advice...

  • Regulatory Compliance Specialist

    1 week ago

    Bengaluru, Karnataka, India beBeeRegulatory Full time ₹ 15,00,000 - ₹ 25,00,000

    Job TitleRegulatory Affairs ExpertiseThis role entails the preparation, review, and maintenance of regulatory documents to ensure compliance with international guidelines and country-specific regulations.The ideal candidate will possess a strong understanding of global regulatory requirements, excellent organizational skills, and experience in dossier...

  • Regulatory Compliance Specialist

    2 weeks ago

    Bengaluru, Karnataka, India beBeeRegulation Full time ₹ 8,00,000 - ₹ 12,00,000

    Regulatory Compliance ProfessionalWe are seeking an experienced Regulatory Compliance Professional to join our team. This role will be responsible for ensuring that our organization is in compliance with all relevant regulatory requirements and laws.The ideal candidate will have a strong understanding of regulatory frameworks, as well as excellent...

  • Regulatory Compliance Professional

    2 weeks ago

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

    GRC Consultant PositionMizuho Global Services Pvt Ltd, a subsidiary of Mizuho Bank, is seeking a skilled GRC Consultant to handle Governance Risk and Compliance for its global operations.Key Responsibilities:Risk Management: Identify, assess, and manage risks related to information security, privacy, and regulatory compliance.ISO 27001 Implementation: Lead...

  • Regulatory Compliance Manager

    7 days ago

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

    Job Title: Regulatory Compliance ManagerJob Description:We are seeking a seasoned Compliance Lead to oversee the development and implementation of our quality management systems. As a key member of our team, you will be responsible for ensuring that our business operations align with industry regulations and standards.Responsibilities:Maintain and improve...

  • Regulatory Compliance Specialist

    1 week ago

    Bengaluru, Karnataka, India beBeeCompliance Full time ₹ 9,00,000 - ₹ 12,00,000

    Job Description:The role of Regulatory Compliance Specialist involves ensuring that all company activities adhere to relevant regulatory requirements. This includes developing and implementing compliance strategies, conducting risk assessments, and providing training to employees.Key Responsibilities:Develop and implement compliance strategies to ensure...

  • Regulatory Compliance Specialist

    1 week ago

    Bengaluru, Karnataka, India beBeeCompliance Full time ₹ 8,00,000 - ₹ 12,00,000

    Job Title: Regulatory Compliance SpecialistOverview:Progenesis IVF Fertility Center seeks a detail-oriented Regulatory Compliance Specialist to ensure compliance with regulatory requirements, build strong relationships with government agencies and external partners, and provide operational support to our clinics.Key Responsibilities:Obtain and renew...

  • Regulatory Compliance Expert

    2 weeks ago

    Bengaluru, Karnataka, India beBeeCompliance Full time ₹ 20,00,000 - ₹ 30,00,000

    Job Role: Regulatory Compliance ExpertA dynamic and expanding enterprise is seeking a skilled regulatory compliance expert to drive operational success.