28 Financial Regulations jobs in Ahmedabad

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 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 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 Description:

A Sr. Regulatory Affairs professional in a Healthcare Pvt. Ltd. is responsible for the preparation, review, and submission of CTD/ACTD/eCTD dossiers, WHO-GMP, ICH, and country-specific requirements for regions such as ROW, LATAM, SEA, Africa, and Pacific. The role involves mentoring junior Regulatory Affairs staff and implementing process improvements to ensure compliance with regulatory standards.

• Prepare, review, and submit CTD/ACTD/eCTD dossiers.
li>Ensure compliance with WHO-GMP, ICH, and country-specific regulatory requirements.
• Manage regulatory submissions for regions including ROW, LATAM, SEA, Africa, and Pacific.
• Mentor junior Regulatory Affairs staff.
• Implement process improvements to enhance regulatory compliance.

• Bachelor's or Master's degree in Pharmacy, Life Sciences, or related field.
• Minimum of 5 years of experience in Regulatory Affairs within the healthcare industry.
• Strong knowledge of regulatory guidelines and requirements for CTD/ACTD/eCTD submissions.
• Experience in working with WHO-GMP, ICH, and country-specific regulations.

• Regulatory Affairs Compliance
• CTD/ACTD/eCTD Submissions
• WHO-GMP Knowledge
• ICH Guidelines
• Process Improvement
• Mentoring and Training

Company Profile:

Our Client’s Company provides tailored intelligent healthcare solutions based on the latest professional insights. Every year, they supply high volumes of healthcare products via pharmaceutical supply programmes across the continent.

Job location: Ahmedabad

Job Profile:

· Assist in preparing and reviewing regulatory submissions and documents.

· Support dossier compilation for product approvals and renewals.

· Ensure compliance with national and international regulatory guidelines (CDSCO, WHO,   USFDA, etc.).

· Maintain records of submissions, approvals, and correspondence.

· Coordinate with internal teams (QA, R&D, Production) for data collection.

· Stay updated on regulatory changes and help implement necessary updates.

Desired Candidate:

M.Pharma (Fresher)

Contact Person:

Rina Arun/Chhavi Kankariya

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 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 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.