40 Regulatory Affairs Managers jobs in Hyderabad

This role is for one of the Weekday's clients

Salary range: Rs - Rs (ie INR 3-8 LPA)

Min Experience: 3 years

Location: India, Hyderabad

JobType: full-time

Requirements

Key Responsibilities:

Drug Master Files (DMF):

• Prepare, compile, and review US DMFs (Type II), EU ASMFs, and other region-specific dossiers.
• Manage lifecycle activities such as updates, deficiency responses, and annual reports.
• Collaborate with internal teams to gather technical documents for submissions.

Regulatory Documentation & Submissions:

• Compile CTD/eCTD dossiers for global regulatory submissions (USFDA, EDQM, WHO, TGA, etc.).
• Ensure adherence to current international regulatory guidelines and standards.
• Maintain accurate records, document control systems, and submission archives.

Cross-Functional Collaboration:

• Coordinate with QA, QC, R&D, and Production teams for necessary documentation and technical inputs.
• Support preparation and review of product specifications, stability data, and Certificates of Analysis (COAs).

Audits & Inspections:

• Provide assistance during regulatory audits and inspections by international authorities and clients.
• Address regulatory queries and observations in a timely manner.

Regulatory Intelligence:

• Monitor and interpret updates in global regulatory guidelines (USFDA, EMA, ICH, etc.).
• Provide inputs on regulatory strategies, product classification, and compliance requirements.

Required Skills & Qualifications:

• Bachelor’s or Master’s degree in Pharmacy, Life Sciences, or a related field.
• 3–7 years of experience in Regulatory Affairs, preferably in pharmaceuticals, nutraceuticals, or herbal formulations.
• Strong understanding of DMF/ASMF preparation and submission processes.
• Familiarity with global regulatory frameworks (USFDA, EMA, TGA, WHO, etc.).
• Excellent documentation, communication, and organizational skills.
• High attention to detail with the ability to manage deadlines effectively.

Company Overview

Gamut HR Solutions, headquartered in Hyderabad, is dedicated to connecting individuals with the right jobs. With a tight-knit team of 2-10 employees, our focus is on providing personalized employment solutions. Discover more about us at .

Job Overview

We are seeking a Mid-Level Regulatory Affairs Assistant to join our team full-time in Hyderabad. This role requires 4 to 6 years of experience in regulatory affairs, ideally in the healthcare or pharmaceutical sector. The candidate will play a vital part in navigating regulatory requirements and ensuring compliance for our projects.

Qualifications and Skills

• Proficiency in clinical trial documentation, ensuring that all protocols, reports, and submissions are accurately completed (Mandatory skill).
• Experience in regulatory submissions, including preparation, filing, and management for different regulatory bodies (Mandatory skill).
• Ability in regulatory strategic planning to develop comprehensive plans for meeting regulatory requirements (Mandatory skill).
• In-depth understanding of FDA regulations to ensure that all processes comply with necessary standards.
• Knowledge of EU MDR compliance, ensuring adherence to European Medical Device Regulation standards.
• Familiarity with GxP standards to assure the quality and integrity of processes and products.
• Experience in quality management systems to oversee processes meeting both internal and external requirements.
• Understanding of labeling requirements to ensure product labels meet regulatory standards.

Roles and Responsibilities

• Assist in the preparation and submission of regulatory documents to appropriate regulatory bodies.
• Coordinate with cross-functional teams to gather necessary documentation for regulatory submissions.
• Monitor and track submissions and ensure all regulatory timelines are met.
• Maintain up-to-date knowledge of regulatory requirements and changes in the regulatory landscape.
• Provide support in the development of regulatory strategies and implementation plans.
• Liaise with internal departments to ensure regulatory compliance is maintained across all projects.
• Prepare and review technical documentation to ensure compliance with regulatory standards.
• Support internal and external audits by gathering necessary documents and evidence.

Job Title: Regulatory Affairs Specialist Med/Pharma (Female)

Location: Remote

Position Overview:

We are seeking an experienced Regulatory Affairs professional with expertise in both pharmaceutical and medical device regulatory compliance. The role involves preparing, reviewing, and submitting regulatory documentation to global health authorities, ensuring compliance with applicable regulations (FDA, EMA, CDSCO, MHRA, ISO 13485, ICH guidelines). The ideal candidate will have a strong background in regulatory submissions, product lifecycle management, and cross-functional collaboration to support product development, registration, and commercialization.

Key Responsibilities:

• Prepared, reviewed, and submitted regulatory filings, including IND, NDA, ANDA, DMF, 510(k), PMA, CE Technical Files, and related applications.
• Ensured compliance with international, federal, and local regulatory requirements across pharmaceuticals and medical devices.
• Interacted with regulatory authorities (FDA, EMA, CDSCO, MHRA, Notified Bodies) during product submissions, inspections, and audits.
• Developed and maintained regulatory strategies to support new product development and lifecycle management.
• Reviewed labeling, promotional materials, and product packaging for compliance with applicable regulations.
• Maintained up-to-date knowledge of regulatory changes, guidelines, and industry best practices to ensure organizational compliance.
• Supported quality systems in alignment with ISO 13485, ICH, and FDA QSR standards.
• Collaborated with R&D, Quality, Manufacturing, and Clinical teams to integrate regulatory requirements into product development.
• Assisted in responding to regulatory queries, deficiency letters, and inspection findings.
• Managed regulatory documentation archives and maintained compliance records for audits and inspections.

Job Title: Regulatory Affairs Specialist Med/Pharma (Female)

Location: Remote

Position Overview:

We are seeking an experienced Regulatory Affairs professional with expertise in both pharmaceutical and medical device regulatory compliance. The role involves preparing, reviewing, and submitting regulatory documentation to global health authorities, ensuring compliance with applicable regulations (FDA, EMA, CDSCO, MHRA, ISO 13485, ICH guidelines). The ideal candidate will have a strong background in regulatory submissions, product lifecycle management, and cross-functional collaboration to support product development, registration, and commercialization.

Key Responsibilities:

• Prepared, reviewed, and submitted regulatory filings, including IND, NDA, ANDA, DMF, 510(k), PMA, CE Technical Files, and related applications.
• Ensured compliance with international, federal, and local regulatory requirements across pharmaceuticals and medical devices.
• Interacted with regulatory authorities (FDA, EMA, CDSCO, MHRA, Notified Bodies) during product submissions, inspections, and audits.
• Developed and maintained regulatory strategies to support new product development and lifecycle management.
• Reviewed labeling, promotional materials, and product packaging for compliance with applicable regulations.
• Maintained up-to-date knowledge of regulatory changes, guidelines, and industry best practices to ensure organizational compliance.
• Supported quality systems in alignment with ISO 13485, ICH, and FDA QSR standards.
• Collaborated with R&D, Quality, Manufacturing, and Clinical teams to integrate regulatory requirements into product development.
• Assisted in responding to regulatory queries, deficiency letters, and inspection findings.
• Managed regulatory documentation archives and maintained compliance records for audits and inspections.

Job Title: Regulatory Affairs Specialist Med/Pharma (Female)

Location: Remote

Position Overview:

We are seeking an experienced Regulatory Affairs professional with expertise in both pharmaceutical and medical device regulatory compliance. The role involves preparing, reviewing, and submitting regulatory documentation to global health authorities, ensuring compliance with applicable regulations (FDA, EMA, CDSCO, MHRA, ISO 13485, ICH guidelines). The ideal candidate will have a strong background in regulatory submissions, product lifecycle management, and cross-functional collaboration to support product development, registration, and commercialization.

Key Responsibilities:

• Prepared, reviewed, and submitted regulatory filings, including IND, NDA, ANDA, DMF, 510(k), PMA, CE Technical Files, and related applications.
• Ensured compliance with international, federal, and local regulatory requirements across pharmaceuticals and medical devices.
• Interacted with regulatory authorities (FDA, EMA, CDSCO, MHRA, Notified Bodies) during product submissions, inspections, and audits.
• Developed and maintained regulatory strategies to support new product development and lifecycle management.
• Reviewed labeling, promotional materials, and product packaging for compliance with applicable regulations.
• Maintained up-to-date knowledge of regulatory changes, guidelines, and industry best practices to ensure organizational compliance.
• Supported quality systems in alignment with ISO 13485, ICH, and FDA QSR standards.
• Collaborated with R&D, Quality, Manufacturing, and Clinical teams to integrate regulatory requirements into product development.
• Assisted in responding to regulatory queries, deficiency letters, and inspection findings.
• Managed regulatory documentation archives and maintained compliance records for audits and inspections.

Company Overview

Gamut HR Solutions, headquartered in Hyderabad, is dedicated to connecting individuals with the right jobs. With a tight-knit team of 2-10 employees, our focus is on providing personalized employment solutions. Discover more about us at .

Job Overview

We are seeking a Mid-Level Regulatory Affairs Assistant to join our team full-time in Hyderabad. This role requires 4 to 6 years of experience in regulatory affairs, ideally in the healthcare or pharmaceutical sector. The candidate will play a vital part in navigating regulatory requirements and ensuring compliance for our projects.

Qualifications and Skills

• Proficiency in clinical trial documentation, ensuring that all protocols, reports, and submissions are accurately completed (Mandatory skill).
• Experience in regulatory submissions, including preparation, filing, and management for different regulatory bodies (Mandatory skill).
• Ability in regulatory strategic planning to develop comprehensive plans for meeting regulatory requirements (Mandatory skill).
• In-depth understanding of FDA regulations to ensure that all processes comply with necessary standards.
• Knowledge of EU MDR compliance, ensuring adherence to European Medical Device Regulation standards.
• Familiarity with GxP standards to assure the quality and integrity of processes and products.
• Experience in quality management systems to oversee processes meeting both internal and external requirements.
• Understanding of labeling requirements to ensure product labels meet regulatory standards.

Roles and Responsibilities

• Assist in the preparation and submission of regulatory documents to appropriate regulatory bodies.
• Coordinate with cross-functional teams to gather necessary documentation for regulatory submissions.
• Monitor and track submissions and ensure all regulatory timelines are met.
• Maintain up-to-date knowledge of regulatory requirements and changes in the regulatory landscape.
• Provide support in the development of regulatory strategies and implementation plans.
• Liaise with internal departments to ensure regulatory compliance is maintained across all projects.
• Prepare and review technical documentation to ensure compliance with regulatory standards.
• Support internal and external audits by gathering necessary documents and evidence.