Senior Regulatory Compliance Specialist

2 days ago


Mumbai, Maharashtra, India SUN PHARMA Full time

The SUN PHARMA team is seeking a highly skilled Senior Regulatory Compliance Specialist to support global health authority communications and ensure regulatory compliance across the organization.

As a key member of our team, you will assist the Head of Health Authority Communication and Correspondence in supporting the coordination of regulatory responses, managing quality deliverables, and preparing materials for regulatory meetings.

About the Role
  • Health Authority Correspondence Management - Assist in reviewing and preparing scientifically accurate, compliant responses to health authority queries and inspection observations. Collaborate with site teams to gather necessary data and draft cohesive, concise responses. Track and manage all regulatory communication activities, ensuring accurate data entry and documentation within regulatory databases in a timely manner.
  • Quality Management System Analysis - Assess findings from inspections, audits, and Quality Management Systems to identify areas for global risk mitigation. Provide support to internal teams to develop appropriate corrective actions.
  • Inspection Readiness – Provide support for all regulatory audits, internal/external inspections, and other audits. Support mock inspections, including review of documents for compliance to current regulations.
  • Compliance Tracking and Reporting - Monitor updates and perform gap assessments on regulatory requirements, especially related to aseptic environments and quality management.
Requirements
  • Degree in a Science/Pharmacy-related field required.
  • 10+ years of experience in quality within the pharmaceutical industry, including experience in an aseptic environment. Microbiology experience is desirable.
  • Knowledge of GxP, cGMP, Quality Systems, and other regulatory requirements.
  • Proficient in Quality Management Systems (QMS) with experience analyzing QMS data.
  • Significant experience in global health authority inspections and audits in the pharmaceutical industry, direct involvement as a team member in writing responses. Experience responding to FDA, MHRA, EMA, or WHO is preferred.

Salary: $120,000 - $150,000 per annum, depending on qualifications and experience.



  • Mumbai, Maharashtra, India The Premier Consultants ( Recruitment Company ) Full time

    We are seeking an experienced and skilled Senior Regulatory Compliance Specialist to join our team at The Premier Consultants (Recruitment Company) in Mumbai.This is a fantastic opportunity for you to take on a challenging role that requires a strong background in Retail Broking, Depository operations, Broking Compliance, or Broking DP. If you have a deep...


  • Mumbai, Maharashtra, India Agrostarc Full time

    Job Title: Senior Food Technologist - Regulatory Compliance SpecialistWe are seeking a highly skilled Senior Food Technologist to join our team at Agrostarc Innovation Centre (AIC) in New Product Development & Regulatory.Company OverviewAgrostarc is a leading innovation centre dedicated to driving scientific and regulatory excellence in the food industry....


  • Mumbai, Maharashtra, India Ashish Life Science Pvt Limited Full time

    Job Title: Regulatory Compliance SpecialistAbout Us:Ashish Life Science Pvt. Limited is a renowned pharmaceutical manufacturing company established in 1975. With a strong presence in over 65 countries, we have earned a reputation for reliability and trustworthiness. Our commitment to quality, innovation, and customer satisfaction extends globally.Job...


  • Mumbai, Maharashtra, India LabelBlind®️ Full time

    We are looking for a highly skilled Regulatory Compliance Specialist to join our team at LabelBlind, India's 1st AI-led Digital Food Labelling Company.As a Regulatory Compliance Specialist, you will be responsible for ensuring that all food labels comply with current and draft labelling regulations in Nutraceuticals and Ayush for India and International...


  • Mumbai, Maharashtra, India Ashish Life Science Pvt Limited Full time

    About the RoleAt Ashish Life Science Pvt. Ltd., we are seeking a skilled Regulatory Compliance Specialist to join our team. This role is responsible for ensuring that our products meet all regulatory requirements for approval and market entry.We estimate the salary for this position to be around $80,000 per year, based on industry standards and the location...


  • Navi Mumbai, Maharashtra, India Omniscience Capital Full time

    Job DescriptionAt Omnicience Capital, we are seeking a highly skilled Regulatory Compliance Specialist to join our team. As a key member of our compliance department, you will be responsible for ensuring that our firm operates within the legal and regulatory framework.Key Responsibilities:- Monitor and ensure compliance with regulatory requirements (SEBI,...


  • Mumbai, Maharashtra, India Ipca Laboratories Limited Full time

    Job DescriptionWe are looking for a highly skilled Regulatory Compliance Specialist to join our team at Ipca Laboratories Limited.This role is responsible for ensuring compliance with regulatory requirements for the USA market. The ideal candidate will have a strong background in regulated markets, specifically in the USA, and experience with ANDA...


  • Mumbai, Maharashtra, India Singularity AMC Full time

    Job DescriptionSingularity AMC is seeking a highly skilled Compliance and Regulatory Specialist to join our team. As a key member of the investment team, you will be responsible for ensuring that our Alternative Investment Funds (AIFs) comply with all relevant regulations and laws.Responsibilities:Ensure SEBI reporting for AIFs and adherence to SEBI/RBI...


  • Mumbai, Maharashtra, India Chemill Pharma Ltd. Full time

    Chemill Pharma Ltd. offers a competitive salary of $120,000 for this challenging role. As a Regulatory Compliance Specialist, you will be responsible for ensuring all regulatory submissions are complete, accurate, and compliant with country-specific guidelines.About the JobThe successful candidate will have a strong understanding of country-specific...


  • Mumbai, Maharashtra, India Archroma Full time

    Job SummaryWe are seeking a highly motivated and proactive Regulatory Compliance Specialist to join our Product Stewardship organization at Archroma.Key ResponsibilitiesDevelop and manage REACH-like registration projects, aligning with the company's global registration strategy.Plan, manage, prepare, and submit substance registration dossiers, advising the...


  • Mumbai, Maharashtra, India Fullon Finance Full time

    About UsFullon Finance Private Limited is a part of the Fullon Group, which aims to obtain a Merchant Banking Category I license. The group is involved in public issues, fund raising, mergers & acquisitions, and financial restructuring.Job Role: Senior Compliance SpecialistLocation: MumbaiJob Description:We seek an experienced Senior Compliance Specialist...


  • Navi Mumbai, Maharashtra, India Hindustan Ports Private Limited Full time

    We are seeking a highly skilled Regulatory Compliance Specialist to join our team at Hindustan Ports Private Limited. The ideal candidate will have hands-on knowledge of prevailing SEZ guidelines and be able to interpret legal requirements and apply them to relevant business operations. With 10-15 years of experience in Special Economic Zones Act and Rules,...


  • Mumbai, Maharashtra, India SUN PHARMA Full time

    About the Role">This Senior Quality Compliance Specialist will be integral to supporting global health authority communications and ensuring regulatory compliance across our organization.The successful candidate will assist the Head of Health Authority Communication and Correspondence in coordinating regulatory responses, managing quality deliverables, and...


  • Mumbai, Maharashtra, India DBS Full time

    Job DescriptionAs a Regulatory Compliance Specialist - Finance, you will play a critical role in ensuring that DBS's finance operations are compliant with regulatory requirements. You will be responsible for managing financial risks, preparing regulatory reports, and ensuring that all financial activities are conducted in accordance with RBI directives.About...


  • Mumbai, Maharashtra, India Talentiser Full time

    Talentiser seeks a Senior Compliance Specialist to support the company's governance practices and ensure compliance with regulatory requirements. This role requires a strong understanding of compliance principles and risk management.Estimated salary: $160,000 - $220,000 per year.The ideal candidate will have 7-10 years of experience in corporate IT and a...


  • Mumbai, Maharashtra, India Sumitomo Mitsui Banking Corporation – SMBC Group Full time

    At Sumitomo Mitsui Banking Corporation – SMBC Group, we are seeking a highly skilled Regulatory Compliance Specialist to join our team in India.About UsSMB is one of the largest Japanese banks by assets, with strong credit ratings across the globe. Our presence in India was established in 2012, and we offer wholesale banking services to local and global...


  • Mumbai, Maharashtra, India Qure Full time

    About Qure:As the world's fastest-growing medical AI company, we have achieved an impressive 18 FDA and 62 CE marking clearances to date. Our cutting-edge solutions enhance patient outcomes across various care domains, including lung cancer, tuberculosis, and stroke. Our technologies have positively impacted over 22 million patients in more than 90 countries...


  • Mumbai, Maharashtra, India IDFCFirst Bank Full time

    Job Title: Lead Compliance SpecialistWe are seeking a Lead Compliance Specialist to join our team at IDFC First Bank. The ideal candidate will have extensive experience in regulatory compliance and excellent leadership skills.Job Purpose:This role involves overseeing the bank's compliance functions to ensure alignment with regulatory requirements and...


  • Mumbai, Maharashtra, India Fullon Finance Full time

    About Us Fullon Finance Private Limited is a leading financial services company and an integral part of the Fullon Group. The group has made significant strides in public issues, fundraising, mergers & acquisitions, and financial restructuring.Role: Senior Compliance Specialist Location: Mumbai, IndiaJob Description:Key Responsibilities:Regulatory...


  • Mumbai, Maharashtra, India SUN PHARMA Full time

    Role Overview:SUN PHARMA is seeking a seasoned Regulatory Compliance Specialist to join its team in ensuring the highest standards of quality and regulatory compliance in the pharmaceutical industry.About the Role:The successful candidate will be an integral part of the company's Quality Assurance team, responsible for supporting global health authority...