Senior Regulatory Compliance Officer

2 days ago

Hyderabad Secunderabad Telangana, India beBeeRegulatoryAffairs Full time ₹ 1,04,000 - ₹ 1,30,878
Regulatory Affairs Specialist

We are seeking a highly skilled Regulatory Affairs Specialist to join our team. This role is responsible for ensuring compliance with regulations and policies, as well as providing support for research and development activities.

About the Role:

This is a dynamic opportunity for a motivated individual who is passionate about regulatory affairs. As a Regulatory Affairs Specialist, you will be responsible for preparing, reviewing, and filing premarket documents for global registrations. You will also collaborate with business unit and international regulatory affairs personnel to support marketing authorizations.

  • Key Responsibilities:
  • Prepare, review, and file premarket documents for global registrations.
  • Collaborate with business unit and international regulatory affairs personnel to support marketing authorizations.
  • Represent Regulatory Affairs as a team member of product development projects from Concept through Commercialization.
  • Review pre-clinical and clinical protocols and associated reports for submissions.
  • Develop Regulatory Strategies for new or modified products.
  • Monitor and provide information on regulatory environment changes.
  • Communicate with regulatory agencies and/or notify bodies on administrative and routine matters.
Requirements:

To be successful in this role, you will need:

  • Bachelor's degree in Medical, Mechanical, Electrical Life Science, or other healthcare-related majors.
  • 4-7 years of experience in a Regulatory Affairs role in the medical device and/or pharmaceutical industry.
  • Good understanding of regulations and policies issued by India, US FDA, and EU, with the ability to interpret international regulatory requirements.
  • Excellent written, organizational, and communication skills.
  • Strong attention to detail and ability to handle multiple tasks.
What We Offer:

We offer a competitive salary and benefits package, as well as opportunities for professional growth and development. If you are a motivated and organized individual who is passionate about regulatory affairs, we encourage you to apply for this exciting opportunity.

  • Senior Manager, Regulatory Affairs and Compliance

    6 days ago

    Hyderabad / Secunderabad, Telangana, India beBeeRegulatory Full time

    Senior Manager, Regulatory Affairs and ComplianceJob Description:The role of Senior Manager, Regulatory Affairs and Compliance involves leading global regulatory strategy with a focus on innovation, ensuring business benefit balanced with regulatory compliance. This includes leading and implementing all global CMC submission activities for assigned...

  • Senior Regulatory Compliance Specialist

    2 days ago

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

    Job Title: Regulatory Affairs Senior AssociateOur company seeks an experienced Regulatory Affairs Senior Associate to join our team. The ideal candidate will have a strong background in regulatory affairs and be able to work effectively with cross-functional teams."],

  • Regulatory Affairs Specialist: Artwork Management and Compliance

    2 days ago

    Hyderabad, Telangana, India beBeeregulatory affairs officer Full time ₹ 40,00,000 - ₹ 80,00,000

    Job Summary:","Regulatory Affairs Specialist: Artwork Management and Compliance"],

  • Regulatory Compliance Specialist

    6 days ago

    Hyderabad / Secunderabad, Telangana, India beBeeCompliance Full time

    Regulatory Compliance SpecialistWe are seeking a highly skilled Regulatory Compliance Specialist to join our team. In this role, you will be responsible for maintaining close cooperation with regulatory authorities to discuss requirements, strategies, and knowledge of global product dossiers to stay up-to-date.Maintain close cooperation with regulatory...

  • Officer 2, Regulatory

    4 days ago

    Hyderabad, Telangana, India IQ-EQ Full time

    **Company Description** IQEQ is a preeminent service provider to the alternative asset industry. IQEQ works with managers in multiple capacities ranging from hedge fund, private equity fund, and mutual fund launches; private equity fund administration; advisory firm set-up, regulatory registration and infrastructure design; ongoing regulatory compliance...

  • Senior Regulatory Compliance Specialist

    6 days ago

    Hyderabad / Secunderabad, Telangana, India beBeeCompliance Full time

    Job DescriptionThe ideal candidate for this position will be responsible for overseeing the development and refinement of processes, as well as partnering with colleagues to create systems and tools that enhance the efficiency of operations over time.This role requires a strong understanding of regulatory compliance and the ability to exemplify the...

  • Regulatory Compliance Specialist

    1 week ago

    Hyderabad / Secunderabad, Telangana, Pune, Chennai, India beBeeCompliance Full time US$ 80,000 - US$ 1,20,000

    Job DescriptionAs a regulatory compliance specialist, you will be responsible for ensuring our products meet the necessary regulatory requirements. This involves product data mining from regulatory data tools, engaging with IT to backfill product data into ERP systems, and providing customer support on regulatory document requests.You will also be involved...

  • Senior Regulatory Compliance Specialist

    3 days ago

    Hyderabad, Telangana, India beBeeRegulatory Full time US$ 80,000 - US$ 1,50,000

    Job Title: Regulatory Affairs Senior AssociateAs a senior associate in regulatory affairs, you will play a critical role in ensuring compliance with regulatory strategies for department initiatives.This position is responsible for assisting in preparing, tracking, reporting, and archiving US regulatory documentation, including preclearance and advisory...

  • Regulatory Compliance Expert

    3 days ago

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

    Regulatory Affairs Specialist JobWe are seeking a highly skilled Regulatory Affairs Specialist to join our team. As a key member of our regulatory team, you will be responsible for ensuring compliance with regulatory requirements and providing strategic inputs to support the development and launch of new products.The successful candidate will have a strong...

  • Regulatory Compliance Specialist

    2 days ago

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

    Job SummaryAs a Regulatory Affairs Manager, you will play a key role in supporting the implementation of automation and digital tools to streamline regulatory CMC documentation and submission workflows.Key Responsibilities:Develop and implement standardized templates and structured data formats to ensure consistent and compliant submissions.Contribute to...