41 Regulatory Affairs Specialist jobs in Hyderabad

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.

At Medtronic you can begin a life-long career of exploration and innovation, while helping champion healthcare access and equity for all. You’ll lead with purpose, breaking down barriers to innovation in a more connected, compassionate world.

A Day in the Life

Responsibilities may include the following and other duties may be assigned.

SPECIALIST CAREER STREAM: An individual contributor with responsibility in a professional discipline or specialty. Delivers and/or manages projects assigned and works with other stakeholders to achieve desired results. Most of the time is spent delivering and overseeing the projects while and adhering to policies, using specialized knowledge and skills normally acquired through advanced education.

DIFFERENTIATING FACTORS

Autonomy: Entry-level individual contributor on a project or work team. Works with close supervision.

Organizational Impact: Delivers work of limited scope, typically smaller, less complex projects, or related activities.

Innovation and Complexity: Identifies, defines, and addresses problems that are not immediately evident but typically not difficult or complex.
Makes minor changes in systems and processes to solve problems.

Communication and Influence: Communicates primarily with internal contacts within immediate group.
Contacts others to gather, confirm and convey information.

Leadership and Talent Management: N / A – job at this level is focused on self-development.

Required Knowledge and Experience: Requires broad theoretical job knowledge typically obtained through advanced education.
Requires a Baccalaureate degree (or for degrees earned outside of the United States, a degree which satisfies the requirements of 8 C.F.R. § 214.2(h)(4)(iii)(A), 2-4 years of experience required.

Physical Job Requirements

The above statements are intended to describe the general nature and level of work being performed by employees assigned to this position, but they are not an exhaustive list of all the required responsibilities and skills of this position. 

Benefits & Compensation

Medtronic offers a competitive Salary and flexible Benefits Package
A commitment to our employees lives at the core of our values. We recognize their contributions. They share in the success they help to create.We offer a wide range of benefits, resources, and competitive compensation plans designed to support you at every career and life stage.
 

About Medtronic

We lead global healthcare technology and boldly attack the most challenging health problems facing humanity by searching out and finding solutions.
Our Mission — to alleviate pain, restore health, and extend life — unites a global team of 95,000+ passionate people. 
We are engineers at heart— putting ambitious ideas to work to generate real solutions for real people. From the R&D lab, to the factory floor, to the conference room, every one of us experiments, creates, builds, improves and solves. We have the talent, diverse perspectives, and guts to engineer the extraordinary.

Learn more about our business, mission, and our commitment to diversity
 

Company Overview

Gamut HR Solutions is dedicated to helping individuals find the right job opportunities effectively and efficiently. With a small yet dynamic team located in Hyderabad, we strive to connect talented professionals with companies in need of their expertise. Visit our website at to learn more about how we can assist in your career advancement.

Job Overview

We are seeking a dedicated Regulatory Affairs Specialist - Pharma to join our team in Hyderabad. This is a full-time, junior-level position designed for candidates with 1 to 3 years of experience. The chosen candidate will be responsible for a variety of regulatory procedures, ensuring compliance and managing strategic regulatory projects within the pharmaceutical sector.

Qualifications and Skills

• Proficient in FDA regulatory submissions, crucial for the timely approval of products (Mandatory skill).
• Skilled in risk management processes, necessary to identify, assess, and prioritize regulatory risks (Mandatory skill).
• Adept at regulatory strategy development to efficiently navigate and comply with complex regulations (Mandatory skill).
• Solid understanding of EU MDR compliance to ensure product safety and efficacy.
• Experience with quality management systems, enabling efficient organization and processes for regulatory compliance.
• Knowledge of ISO 13485 standards for designing and manufacturing medical devices.
• Competency in labeling and documentation review to ensure accuracy and regulatory compliance.
• Experience in product lifecycle management to oversee the entire regulatory process from development to post-market.

Roles and Responsibilities

• Preparing and submitting regulatory documents to ensure compliance with regional and international regulatory requirements.
• Collaborating with cross-functional teams to support regulatory strategies and submissions.
• Conducting risk assessments and implementing risk mitigation strategies.
• Maintaining up-to-date knowledge of regulatory legislation, guidelines, and standards.
• Reviewing and approving labeling, promotional, and support materials.
• Managing timelines and delivering high-quality regulatory submissions within set deadlines.
• Providing regulatory input for new product development and design changes.
• Participating in regulatory inspections and audits as required.

Company Overview

Gamut HR Solutions is dedicated to helping individuals find the right job opportunities effectively and efficiently. With a small yet dynamic team located in Hyderabad, we strive to connect talented professionals with companies in need of their expertise. Visit our website at to learn more about how we can assist in your career advancement.

Job Overview

We are seeking a dedicated Regulatory Affairs Specialist - Pharma to join our team in Hyderabad. This is a full-time, junior-level position designed for candidates with 1 to 3 years of experience. The chosen candidate will be responsible for a variety of regulatory procedures, ensuring compliance and managing strategic regulatory projects within the pharmaceutical sector.

Qualifications and Skills

• Proficient in FDA regulatory submissions, crucial for the timely approval of products (Mandatory skill).
• Skilled in risk management processes, necessary to identify, assess, and prioritize regulatory risks (Mandatory skill).
• Adept at regulatory strategy development to efficiently navigate and comply with complex regulations (Mandatory skill).
• Solid understanding of EU MDR compliance to ensure product safety and efficacy.
• Experience with quality management systems, enabling efficient organization and processes for regulatory compliance.
• Knowledge of ISO 13485 standards for designing and manufacturing medical devices.
• Competency in labeling and documentation review to ensure accuracy and regulatory compliance.
• Experience in product lifecycle management to oversee the entire regulatory process from development to post-market.

Roles and Responsibilities

• Preparing and submitting regulatory documents to ensure compliance with regional and international regulatory requirements.
• Collaborating with cross-functional teams to support regulatory strategies and submissions.
• Conducting risk assessments and implementing risk mitigation strategies.
• Maintaining up-to-date knowledge of regulatory legislation, guidelines, and standards.
• Reviewing and approving labeling, promotional, and support materials.
• Managing timelines and delivering high-quality regulatory submissions within set deadlines.
• Providing regulatory input for new product development and design changes.
• Participating in regulatory inspections and audits as required.

Key Responsibilities:Lead and manage CMC regulatory activities for USFDA submissions including ANDA preparation, review, and filing.Oversee compilation and submission of Annual Reports, amendments, and deficiency responses.Interface with cross-functional teams including Quality Assurance, Production, and R&D to gather required documentation and data.Review and ensure compliance of Batch Manufacturing Records (BMR), process validation documents, and site-related data.Coordinate with manufacturing units to ensure product and process compliance aligned with regulatory requirements.Stay updated on evolving USFDA regulations and provide impact assessment and strategic guidance.Key Requirements:7–10 years of hands-on experience in Regulatory Affairs – CMC with USFDA filings (especially ANDAs).Strong understanding of ICH, USFDA guidelines, and regulatory frameworks applicable to generic drug products.Experience in preparing and reviewing technical documents: Module 2 & 3 (CTD format).Exposure to quality systems, BMR review, and interacting with production/plant teams.Ability to handle end-to-end submission lifecycle including post-approval changes and correspondence with USFDA.

Key Responsibilities :

• Lead and manage CMC regulatory activities for USFDA submissions including ANDA preparation, review, and filing .
• Oversee compilation and submission of Annual Reports , amendments, and deficiency responses.
• Interface with cross-functional teams including Quality Assurance, Production, and R&D to gather required documentation and data.
• Review and ensure compliance of Batch Manufacturing Records (BMR) , process validation documents, and site-related data.
• Coordinate with manufacturing units to ensure product and process compliance aligned with regulatory requirements.
• Stay updated on evolving USFDA regulations and provide impact assessment and strategic guidance.

Key Requirements :

• 7–10 years of hands-on experience in Regulatory Affairs – CMC with USFDA filings (especially ANDAs) .
• Strong understanding of ICH, USFDA guidelines , and regulatory frameworks applicable to generic drug products.
• Experience in preparing and reviewing technical documents : Module 2 & 3 (CTD format).
• Exposure to quality systems, BMR review , and interacting with production /plant teams.
• Ability to handle end-to-end submission lifecycle including post-approval changes and correspondence with USFDA.

Key Responsibilities :

• Lead and manage CMC regulatory activities for USFDA submissions including ANDA preparation, review, and filing .
• Oversee compilation and submission of Annual Reports , amendments, and deficiency responses.
• Interface with cross-functional teams including Quality Assurance, Production, and R&D to gather required documentation and data.
• Review and ensure compliance of Batch Manufacturing Records (BMR) , process validation documents, and site-related data.
• Coordinate with manufacturing units to ensure product and process compliance aligned with regulatory requirements.
• Stay updated on evolving USFDA regulations and provide impact assessment and strategic guidance.

Key Requirements :

• 7–10 years of hands-on experience in Regulatory Affairs – CMC with USFDA filings (especially ANDAs) .
• Strong understanding of ICH, USFDA guidelines , and regulatory frameworks applicable to generic drug products.
• Experience in preparing and reviewing technical documents : Module 2 & 3 (CTD format).
• Exposure to quality systems, BMR review , and interacting with production /plant teams.
• Ability to handle end-to-end submission lifecycle including post-approval changes and correspondence with USFDA.