738 Regulatory Affairs Specialist jobs in India

Position Summary

The Regulatory Affairs Specialist will be responsible for managing regulatory activities for biosimilar products for the emerging market, with a strong focus on LATAM region. This role involves ensuring compliance with regional regulations, supporting product lifecycle management, and leading submissions for primary filings and variations in emerging markets. Key Activities required for this job are as below

• Develop and implement regulatory strategies for biosimilar products in LATAM.

• Prepare, review, and submit dossiers for marketing authorization applications (MAAs), renewals, and variations in compliance with local requirements.

• Ensure adherence to regional regulatory reuqirements

• Evaluate and implement regulatory changes impacting product lifecycle.

• Manage post-approval activities including labeling updates, renewals, and change control assessments.

• Ensure compliance with regional regulations and company SOPs.

• Maintain up-to-date knowledge of LATAM regulatory guidelines, including Module 1 (m1) requirements for submissions.

• Liaise with local health authorities, business partners, and internal teams (CMC, QA, PV, Medical Affairs).

• Support agency meeting preparations and GMP certification processes.

• Assess regulatory impact of manufacturing and quality changes.

• Define submission plans and timelines for change control activities.

• Hands-on experience with biosimilars submission.

Experience:

Minimum 4 years in Regulatory Affairs within the pharmaceutical/biotech industry

Company Description

Rymo Technology is developing intelligent robotic rehabilitation systems that transform physical therapy through data-driven insights, automation, and clinical precision. Our mission is to make rehab smarter, faster, and accessible at scale.

Role Description

As a Regulatory Affairs Specialist at Rymo Technologies, you will be responsible for guiding our innovative physical therapy and rehabilitation devices through medical device regulations. You will manage end-to-end regulatory submissions, ensure compliance with national and international standards, and maintain essential documentation for approvals and certifications. Your will be responsible to ensure that Rymo’s products not only meet safety and quality requirements but also reach the market efficiently to make a meaningful impact on patient recovery and healthcare outcomes.

Key Responsibilities:

• Manage regulatory submissions (CDSCO, FDA, CE etc) and maintain documentation including Device Master Files, Risk Management, and Clinical Evaluation Reports.
• Ensure compliance with ISO 13485, ISO 14971, and relevant IEC standards across the product lifecycle.
• Track post-market requirements, including incident reporting, vigilance activities, and license renewals.
• Design and oversee quality systems, conduct internal and supplier audits, and support regulatory inspections.
• Monitor compliance across departments, manage CAPA processes, and drive continuous process improvements.
• Maintain robust documentation, traceability, and record-keeping throughout development and manufacturing.

Required Qualifications

• Bachelor's degree in Biomedical, Pharmacy, Regulatory Affairs, or related fields.
• 2–5 years in regulatory affairs (medical devices, health-tech, or diagnostics).
• Strong knowledge of Indian medical device regulations (CDSCO); exposure to EU MDR is a plus.
• Experience preparing technical files and regulatory submissions.
• Excellent documentation, attention to detail, and cross-functional communication skills.

Preferred Qualifications

• Exposure to robotic or electro-mechanical medical systems.
• Certification in Regulatory Affairs or Quality Management (ISO 13485 Lead Auditor, RAC, Six Sigma, etc.) is an advantage.
• Familiarity with IEC 60601, IEC 62304, or ISO 14971 standards.
• Experience with CE marking or international regulatory frameworks.

Job Title: Regulatory Affairs Junior Manager

Location: At Ahmedabad Office , Near Thaltej Crossroads

Department: RA

Reports To: RA Head and Regulatory Department at HO /Director

Employment Type: Full Time

Office hours : 9,30 AM to 6 PM

Week of: Sunday and Saturday Half Day

Preferred Gender : M/F

Experience : Minimum 2 years

Job Summary:

We are seeking a proactive and detail-oriented Regulatory Affairs Executive to support the regulatory compliance activities for Class III medical devices . The ideal candidate will have a strong understanding of global medical device regulations and experience in preparing and submitting regulatory dossiers. You will collaborate with cross-functional teams to ensure regulatory strategies align with company goals and support product lifecycle management.

Key Responsibilities:

• Prepare, compile, and submit regulatory documents for Class III medical devices in accordance with global regulatory requirements (e.g., US FDA, EU MDR, India CDSCO, etc.).
• Maintain regulatory approvals by preparing timely renewal applications, variations, and amendments.
• Support product development teams with regulatory input during the design and development phases.
• Conduct regulatory impact assessments for design or process changes.
• Monitor and interpret evolving global regulations and standards applicable to Class III medical devices.
• Coordinate with external regulatory agencies and notified bodies for regulatory submissions and audits.
• Maintain and update regulatory files and records in compliance with company SOPs and applicable regulations.
• Assist in internal audits and inspections, including document preparation and response coordination.
• Ensure labelling, IFUs, and promotional materials comply with applicable regulatory requirements.
• Participate in risk management, clinical evaluation, and post-market surveillance activities.

Qualifications:

• Bachelor’s or Master’s degree in Life Sciences, Biomedical Engineering, Pharmacy, or a related field.
• Minimum 2 years of hands-on experience in regulatory affairs, specifically with Class III medical devices .
• Knowledge of medical device regulations such as EU MDR , US FDA 21 CFR Part 820 , ISO 13485 , and CDSCO requirements.
• Experience in dossier preparation (e.g., 510(k), PMA, CE technical files).
• Strong analytical, organizational, and communication skills.
• Attention to detail and ability to work independently as well as in a team environment.

Preferred Qualifications:

• Certification in Regulatory Affairs (e.g., RAC) is a plus.
• Experience interacting with regulatory bodies or notified bodies.
• Familiarity with eCTD or electronic submission platforms.

Job Summary:

• We are seeking a highly skilled Regulatory Affairs Specialist to join our team. The successful candidate will be responsible for ensuring compliance with regulatory requirements for our products, managing the submission process for regulatory approvals, and maintaining up-to-date knowledge of regulatory changes.

Essential Duties and Responsibilities :

• Regulatory Compliance : Ensure company products comply with relevant regulatory requirements, such as USFDA, FDA, EMA, and local regulations.

• Submission Management : Prepare and submit regulatory documents, such as INDs, NDAs, and MAAs, to regulatory agencies.

• Software: Good knowledge about regulatory software’s like, Pharmareddy, eCTD Global, Educe Solution.

• Competency: Thorough knowledge in filling DMF/Master files/Submissions to countries like Europe/UK, Australia, Brazil, GCC, Jordan, Switzerland, Ukraine, Tunisia, Singapore, Mexico.

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