Regulatory Compliance Specialist

5 hours ago

Pune, Maharashtra, India beBeeCompliance Full time ₹ 10,00,000 - ₹ 15,00,000

Regulatory Compliance Specialist Role Overview

We are seeking a highly skilled Regulatory Compliance Specialist to join our team. The ideal candidate will have expertise in managing pharmaceutical and biological documentation, including registration applications for chemical active substances, biological medicinal products, and data control activities.

The successful candidate will be responsible for ensuring adherence to the Drugs and Cosmetics Act, India GMP, and USFDA CGMP. Additionally, they will maintain cell therapy guidelines, USFDA guidelines, EMA, and animal safety & efficacy studies with GLP-certified laboratory/testing facility (preclinical and non-clinical related activities).

Main Responsibilities:

  • Familiarity with CPMP-ICH or CPMP guidelines is essential for this role.
  • Process validation and manufacturing process development experience is required.
  • Validation of analytical procedures and stability data is crucial.
  • Adventitious safety evaluation and process validation scheme for drug products must be understood.
  • Validation of analytical methods and analytical methodology is necessary.
  • Extensive knowledge of pharmacology, pharmacokinetics, toxicokinetics, toxicology, genotoxicity, carcinogenicity, local tolerance is required.
  • Safety pharmacology studies for human pharmaceuticals are an essential aspect of this role.
  • Single dose toxicity and repeated dose toxicity studies must be conducted.
  • Clinical trials and clinical study reports are critical components of this position.
  • Efficacy and safety studies are ongoing.
  • Post-marketing experience and statutory fulfillment are also key responsibilities.
  • Presenting and conducting meetings with regulatory agencies, CROs, national & international authorities is a significant part of this role.

Functional Area: Regulatory Affairs Manager, Quality Assurance, QA, QA Head, Head Quality, Regulatory Affairs Executive, Regulatory Affairs, Quality Assurance Manager, CMC, Stem Cells Therapy, Cells Therapy, Biopharma, Biotechnology.

About Us: We offer a dynamic work environment that fosters growth and development. Our company is committed to providing exceptional service to our clients while upholding the highest standards of quality and integrity.

What We Offer:

  • A competitive salary package.
  • Ongoing training and professional development opportunities.
  • A collaborative and supportive work environment.
  • The chance to work on challenging projects that make a real difference.

  • Insurance Regulatory Compliance Expert

    3 days ago

    Pune, Maharashtra, India beBeeCompliance Full time ₹ 1,50,00,000 - ₹ 2,00,00,000

    Business Development and Insurance Compliance SpecialistOur organization is seeking an experienced Business Development and Insurance Compliance Specialist with a deep understanding of insurance finance regulatory compliance and accounting standards. The ideal candidate will have expertise in analyzing business and regulatory requirements to ensure...

  • Environmental Regulatory Compliance Expert

    2 days ago

    Pune, Maharashtra, India beBeeelectronics Full time

    Electronics Compliance Specialist">The Electronics Compliance Specialist is responsible for ensuring all products and components meet RoHS compliance requirements. This includes managing compliance documentation, conducting supplier audits, and providing training to internal teams.This role involves overseeing laboratory testing to ensure products meet RoHS...

  • Senior Regulatory Compliance Expert

    2 days ago

    Pune, Maharashtra, India beBeeRegulatory Full time ₹ 1,50,00,000 - ₹ 2,00,00,000

    Job Overview:We are seeking an experienced Regulatory Compliance Specialist to join our team. This role will be responsible for managing CMC regulatory activities, including preparing and submitting documentation to the USFDA.Main Responsibilities:Lead and coordinate CMC regulatory submissions, ensuring compliance with USFDA regulations and...

  • Compliance Verification Specialist

    1 day ago

    Pune, Maharashtra, India beBeeCompliance Full time ₹ 15,00,000 - ₹ 21,00,000

    Compliance Verification SpecialistWe seek a Compliance Verification Specialist to oversee testing of our processes and products, ensuring adherence to regulatory requirements.This position is responsible for developing an annual testing plan, identifying scope, and leading a team to perform compliance verification. Results will be discussed with business...

  • Senior Regulatory Compliance Officer

    7 hours ago

    Pune, Maharashtra, India beBeeCompliance Full time ₹ 8,00,000 - ₹ 12,00,000

    Compliance Leadership Role We are seeking a highly experienced Compliance Leader to spearhead our regulatory reporting efforts. As a key member of the organization, you will be responsible for ensuring accuracy, timeliness, and completeness of reporting across various regulations. Key Qualifications:Proven experience in regulatory reporting and compliance...

  • Regulatory Compliance Specialist

    34 minutes ago

    Pune, Maharashtra, India beBeeRegulation Full time ₹ 15,00,000 - ₹ 25,00,000

    Regulatory Analyst Position OverviewThis role entails providing oversight and management of trade transactions and regulatory reporting processes.The ideal candidate will have relevant experience in managing stakeholder relationships, performing regulatory reporting BAU processes, and conducting comprehensive reconciliation between source systems and trade...

  • Compliance Testing Specialist

    3 hours ago

    Pune, Maharashtra, India beBeeRegulatory Full time ₹ 12,21,000 - ₹ 21,64,500

    Job Description:\Entities Compliance Testing Specialist\item Develop an annual compliance testing blueprint that takes into account regulatory risks and senior management feedback.\item Design and implement rigorous testing protocols, training a team to conduct these procedures effectively.\item Define scope and lead a team in executing thorough compliance...

  • Tax Compliance Specialist

    23 hours ago

    Pune, Maharashtra, India beBeeCompliance Full time ₹ 15,00,000 - ₹ 20,00,000

    Job Title: Tax Compliance SpecialistWe are seeking an experienced and detail-oriented tax compliance specialist to oversee the end-to-end management of sales and use tax compliance for our operations.Key Responsibilities:Manage end-to-end US sales and use tax compliance, including accurate and timely filing of returns across multiple states and...

  • Compliance Specialist

    4 weeks ago

    Pune, Maharashtra, India Tata Elxsi Full time

    The Privacy Compliance Specialist is responsible for supporting the organization's information security program, including, but not limited to, cybersecurity, GDPR, and HIPAA. This role is critical for the safety and security of products and organization. The successful applicant will collaborate closely with all teams within the organization.KEY Roles &...

  • Expert Tax Compliance Specialist

    36 minutes ago

    Pune, Maharashtra, India beBeeTax Full time US$ 60,000 - US$ 1,50,000

    Job Title: Tax Operations Specialist As a Tax Operations Specialist, you will bridge the gap between tax domain expertise and AI-driven automation. You'll work closely with product managers, engineers, and client teams to ensure our solutions address real-world tax compliance and reporting challenges while meeting industry standards and regulatory...