3208 Regulatory Affairs Jobs - Page 23

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5.0 - 10.0 years

25 - 30 Lacs

gurugram

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1) Job Position : Founding Leadership Member & AVP / Director / Sr Consultant / Manager- Medical Operation or Medical Affairs- Global Digital Health Startup. Or General Manager / Manager-Medical Business Head -Global Digital Health Startup. 2) Job Location : Gurugram 3) Domain Expertise Areas & Role & Responsibility: Should be able to do as follows: Role & Responsibility : To work in the Top Management Founding Leadership role in Medical (Chronic Disease Oncology|Diabetes|Heart|Mental Health| COPD) as a Single-handed doer and as a Team Leader. -Top 1st Priority A) Medical R & D : - In-depth Clinical Knowledge in Chronic diseases of Oncology| Diabetes| Heart Disease | COPD | Mental Health. - ...

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5.0 - 10.0 years

25 - 30 Lacs

pune

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1) Job Position : Founding Leadership Member & AVP / Director / Sr Consultant / Manager- Medical Operation or Medical Affairs- Global Digital Health Startup. Or General Manager / Manager-Medical Business Head -Global Digital Health Startup. 2) Job Location : Pune 3) Domain Expertise Areas & Role & Responsibility: Should be able to do as follows: Role & Responsibility : To work in the Top Management Founding Leadership role in Medical (Chronic Disease Oncology|Diabetes|Heart|Mental Health| COPD) as a Single-handed doer and as a Team Leader. -Top 1st Priority A) Medical R & D : - In-depth Clinical Knowledge in Chronic diseases of Oncology| Diabetes| Heart Disease | COPD | Mental Health. - Clin...

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5.0 - 10.0 years

25 - 30 Lacs

mumbai

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1) Job Position : Founding Leadership Member & AVP / Director / Sr Consultant / Manager- Medical Operation or Medical Affairs- Global Digital Health Startup. Or General Manager / Manager-Medical Business Head -Global Digital Health Startup. 2) Job Location : Mumbai 3) Domain Expertise Areas & Role & Responsibility: Should be able to do as follows: Role & Responsibility : To work in the Top Management Founding Leadership role in Medical (Chronic Disease Oncology|Diabetes|Heart|Mental Health| COPD) as a Single-handed doer and as a Team Leader. -Top 1st Priority A) Medical R & D : - In-depth Clinical Knowledge in Chronic diseases of Oncology| Diabetes| Heart Disease | COPD | Mental Health. - Cl...

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5.0 - 10.0 years

20 - 30 Lacs

kanpur

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Domain Expertise Areas & Role & Responsibility: Should be able to do as follows: Role & Responsibility : To work in the Top Management Founding Leadership role in Medical (Chronic Disease Oncology|Diabetes|Heart|Mental Health| COPD) as a Single-handed doer and as a Team Leader. -Top 1st Priority A) Medical R & D : - In-depth Clinical Knowledge in Chronic diseases of Oncology| Diabetes| Heart Disease | COPD | Mental Health. - Clinical Data Development, Clinical Data Acquisition, Clinical Validation for the requirement for AI Health & Clinical Data Management. - Clinical R & D & execution. Working in collaboration with the worlds Top Specialty Research Hospitals for multi-centred R & D. - KOL ...

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5.0 - 10.0 years

20 - 30 Lacs

gurugram

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Domain Expertise Areas & Role & Responsibility: Should be able to do as follows: Role & Responsibility : To work in the Top Management Founding Leadership role in Medical (Chronic Disease Oncology|Diabetes|Heart|Mental Health| COPD) as a Single-handed doer and as a Team Leader. -Top 1st Priority A) Medical R & D : - In-depth Clinical Knowledge in Chronic diseases of Oncology| Diabetes| Heart Disease | COPD | Mental Health. - Clinical Data Development, Clinical Data Acquisition, Clinical Validation for the requirement for AI Health & Clinical Data Management. - Clinical R & D & execution. Working in collaboration with the worlds Top Specialty Research Hospitals for multi-centred R & D. - KOL ...

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5.0 - 10.0 years

20 - 30 Lacs

lucknow

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This is not a job opportunity. The job you can get with any and many companies, but a million dollars high Career growth Opportunity for long term you can't get everywhere. 1) Job Position : Founding Leadership Member & AVP / Director / Sr Consultant / Manager- Medical Operation or Medical Affairs- Global Digital Health Startup. Or General Manager / Manager-Medical Business Head -Global Digital Health Startup. 2) Job Location : Delhi (NCR) at our new coming up Global HQ, Global Technology Development Center & Global R & D & AI Health Innovation Center, Delhi NCR, India : But, Currently and Initially remotely based in Delhi NCR due to COVID-19. 3) Domain Expertise Areas & Role & Responsibilit...

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5.0 - 10.0 years

20 - 30 Lacs

chennai

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Domain Expertise Areas & Role & Responsibility: Should be able to do as follows: Role & Responsibility : To work in the Top Management Founding Leadership role in Medical (Chronic Disease Oncology|Diabetes|Heart|Mental Health| COPD) as a Single-handed doer and as a Team Leader. -Top 1st Priority A) Medical R & D : - In-depth Clinical Knowledge in Chronic diseases of Oncology| Diabetes| Heart Disease | COPD | Mental Health. - Clinical Data Development, Clinical Data Acquisition, Clinical Validation for the requirement for AI Health & Clinical Data Management. - Clinical R & D & execution. Working in collaboration with the worlds Top Specialty Research Hospitals for multi-centred R & D. - KOL ...

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5.0 - 10.0 years

20 - 30 Lacs

kolkata

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Domain Expertise Areas & Role & Responsibility: Should be able to do as follows: Role & Responsibility : To work in the Top Management Founding Leadership role in Medical (Chronic Disease Oncology|Diabetes|Heart|Mental Health| COPD) as a Single-handed doer and as a Team Leader. -Top 1st Priority A) Medical R & D : - In-depth Clinical Knowledge in Chronic diseases of Oncology| Diabetes| Heart Disease | COPD | Mental Health. - Clinical Data Development, Clinical Data Acquisition, Clinical Validation for the requirement for AI Health & Clinical Data Management. - Clinical R & D & execution. Working in collaboration with the worlds Top Specialty Research Hospitals for multi-centred R & D. - KOL ...

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5.0 - 10.0 years

4 - 8 Lacs

mehsana, kadi

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The ideal candidate brings 5 to 10 years and a strong record of GMP/cGMP compliance within regulated pharma, chemicals or biotech environments Key responsibilities include ownership of day-to-day operations, documentation integrity, SOP creation/review, deviation/OOS handling, CAPA and change control management, audit readiness, cross-functional coordination with Production, QC, Engineering and Supply Chain, and proactive risk assessment to protect product quality and patient safety The role requires hands-on problem solving, stakeholder communication, coaching junior staff, and contribution to continuous improvement (5S/Lean/Kaizen) Additional info: Key Skills: DMF Compilation, QA Coordinat...

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10.0 - 15.0 years

12 - 16 Lacs

amritsar

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The ideal candidate brings 10- 15 yrs exp and a strong record of GMP/cGMP compliance within regulated pharma, chemicals or biotech environments Key responsibilities include ownership of day-to-day operations, documentation integrity, SOP creation/review, deviation/OOS handling, CAPA and change control management, audit readiness, cross-functional coordination with Production, QC, Engineering and Supply Chain, and proactive risk assessment to protect product quality and patient safety The role requires hands-on problem solving, stakeholder communication, coaching junior staff, and contribution to continuous improvement (5S/Lean/Kaizen) Lead microbiology practices including EM, MLT, sterility ...

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15.0 - 20.0 years

10 - 14 Lacs

narmada

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The ideal candidate brings 15-20 years and a strong record of GMP/cGMP compliance within regulated pharma, chemicals or biotech environments. Key responsibilities include ownership of day-to-day operations, documentation integrity, SOP creation/review, deviation/OOS handling, CAPA and change control management, audit readiness, cross-functional coordination with Production, QC, Engineering and Supply Chain, and proactive risk assessment to protect product quality and patient safety. The role requires hands-on problem solving, stakeholder communication, coaching junior staff, and contribution to continuous improvement (5S/Lean/Kaizen). Plan resources, ensure statutory compliance, drive traini...

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5.0 - 10.0 years

4 - 8 Lacs

kadi, gujarat, mehsana district

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Assistant Manager / Sr. Executive based in Kadi, Mehsana District, Gujarat. The ideal candidate brings 5 to 10 years and a strong record of GMP/cGMP compliance within regulated pharma, chemicals or biotech environments. Key responsibilities include ownership of day-to-day operations, documentation integrity, SOP creation/review, deviation/OOS handling, CAPA and change control management, audit readiness, cross-functional coordination with Production, QC, Engineering and Supply Chain, and proactive risk assessment to protect product quality and patient safety. The role requires hands-on problem solving, stakeholder communication, coaching junior staff, and contribution to continuous improveme...

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15.0 - 20.0 years

4 - 7 Lacs

narmada

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Chemist (On Contract) (MP 25/20) based in Narmada, Gujarat. The ideal candidate brings 15-20 years and a strong record of GMP/cGMP compliance within regulated pharma, chemicals or biotech environments. Key responsibilities include ownership of day-to-day operations, documentation integrity, SOP creation/review, deviation/OOS handling, CAPA and change control management, audit readiness, cross-functional coordination with Production, QC, Engineering and Supply Chain, and proactive risk assessment to protect product quality and patient safety. The role requires hands-on problem solving, stakeholder communication, coaching junior staff, and contribution to continuous improvement (5S/Lean/Kaizen...

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2.0 - 4.0 years

5 - 8 Lacs

amritsar

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HVAC & Water System Engineers 2 Posts based in Amritsar. The ideal candidate brings 2 - 4 yrs exp and a strong record of GMP/cGMP compliance within regulated pharma, chemicals or biotech environments. Key responsibilities include ownership of day-to-day operations, documentation integrity, SOP creation/review, deviation/OOS handling, CAPA and change control management, audit readiness, cross-functional coordination with Production, QC, Engineering and Supply Chain, and proactive risk assessment to protect product quality and patient safety. The role requires hands-on problem solving, stakeholder communication, coaching junior staff, and contribution to continuous improvement (5S/Lean/Kaizen)...

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5.0 - 10.0 years

4 - 7 Lacs

vapi

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HPLC Operator (01 Position) based in Vapi, Gujarat. The ideal candidate brings 5 to 10 years and a strong record of GMP/cGMP compliance within regulated pharma, chemicals or biotech environments. Key responsibilities include ownership of day-to-day operations, documentation integrity, SOP creation/review, deviation/OOS handling, CAPA and change control management, audit readiness, cross-functional coordination with Production, QC, Engineering and Supply Chain, and proactive risk assessment to protect product quality and patient safety. The role requires hands-on problem solving, stakeholder communication, coaching junior staff, and contribution to continuous improvement (5S/Lean/Kaizen). Ope...

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6.0 - 7.0 years

4 - 6 Lacs

amritsar

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Autocad Operator 1 Pos based in Amritsar. The ideal candidate brings 6-7 yrs exp and a strong record of GMP/cGMP compliance within regulated pharma, chemicals or biotech environments. Key responsibilities include ownership of day-to-day operations, documentation integrity, SOP creation/review, deviation/OOS handling, CAPA and change control management, audit readiness, cross-functional coordination with Production, QC, Engineering and Supply Chain, and proactive risk assessment to protect product quality and patient safety. The role requires hands-on problem solving, stakeholder communication, coaching junior staff, and contribution to continuous improvement (5S/Lean/Kaizen). Operate and tro...

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15.0 - 20.0 years

4 - 7 Lacs

narmada

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Boiler Engineer (On Contract) (MP 25/19) based in Narmada, Gujarat. The ideal candidate brings 15-20 years and a strong record of GMP/cGMP compliance within regulated pharma, chemicals or biotech environments. Key responsibilities include ownership of day-to-day operations, documentation integrity, SOP creation/review, deviation/OOS handling, CAPA and change control management, audit readiness, cross-functional coordination with Production, QC, Engineering and Supply Chain, and proactive risk assessment to protect product quality and patient safety. The role requires hands-on problem solving, stakeholder communication, coaching junior staff, and contribution to continuous improvement (5S/Lea...

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12.0 - 15.0 years

13 - 17 Lacs

kathua

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QC Head 1 Pos based in Kathua, Jammu & Kashmir. The ideal candidate brings 12 - 15 yrs exp. and a strong record of GMP/cGMP compliance within regulated pharma, chemicals or biotech environments. Key responsibilities include ownership of day-to-day operations, documentation integrity, SOP creation/review, deviation/OOS handling, CAPA and change control management, audit readiness, cross-functional coordination with Production, QC, Engineering and Supply Chain, and proactive risk assessment to protect product quality and patient safety. The role requires hands-on problem solving, stakeholder communication, coaching junior staff, and contribution to continuous improvement (5S/Lean/Kaizen). Mana...

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4.0 - 8.0 years

3 - 7 Lacs

bengaluru

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Primary Responsibilities: Manage the preparation and submission of new product registrations, post approval submission and follow-up closely on queries and through approval. Responsible for writing CMC modules 2 & 3. Exposure to EU & CIS region in Regulatory filings Manage and coordinate product life cycle management. Ensure regulatory compliance with local regulatory requirements. Foster and maintain professional relationships with the health authorities. Provide regulatory support including timely registration of new product and line extensions to support new product launches, tender application, and whenever necessary. Maintain regulatory work processes and tracking tools that improve per...

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8.0 - 12.0 years

11 - 15 Lacs

navi mumbai

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Role & responsibilities 1. Preparation and reviewing of CTD and ACTD dossier. 2. Co-ordination with Plant and R&D to collect inputs required for Regulatory Submission. 3. Co-ordination with plant for Regulatory compliances. 4. Timely achievement of monthly plan & timely query response. 5. Gap Analysis/Updation of Master data. 6. Review of Change Controls, Stability Protocol, Clinical Trial Protocols & Artworks. 7. Get feedback from all the countries for respective variation, and there timely submission. 8. renewals. 9. Master data Updating. 10. Follow ups with plant for documentation regularly and review meeting. Tracking and reviewing of document requirements of upcoming new filing in ROW a...

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2.0 - 7.0 years

2 - 7 Lacs

hyderabad

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Role & responsibilities CMC and Labelling: Preparation of ANDAs in eCTD format for various type of formulations Review of the technical documents such as Specifications, BMR, MFC, Able to work on All type of CTD section write-ups Hands on experience on life cycle management activity (AR, CBE, CBE-30 and PAS) Through knowledge on ICH guidances Should able to handle Module -I related activities Able to review Drug substance DMF and should prepare a due diligence eCTD Related activities: Complete knowledge on eCTD related publishing activities Practical knowledge on PDF attributes such as book marking, intra inter hyper ink, file destination TOC’s etc., should adhere to FDA published latest gui...

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2.0 - 7.0 years

3 - 8 Lacs

hyderabad

Work from Office

Role & responsibilities Walk In Drive for API Regulatory Affairs Dept (RA) @ R&D Center Work Location :- MSN Laboratories Pvt. Ltd. MSN R&D center, Pashamylaram, Isnapur, Patancheru, Sangareddy Interview Date:- 25-10-2025 @Saturday & 26-10-2025 @Sunday Interview Time :- 9AM TO 5PM Venue Details : Quality Inn Ramachandra Ward No- 58, 31-41/10/1, Duvvada, Revenue, Visakhapatnam, Andhra Pradesh 530046 Contact :- 9154811048 Regulatory Affairs Specialist to join our API Division. This role is critical to ensuring compliance with regulatory requirements for our active pharmaceutical ingredients (APIs). The ideal candidate should have 1-7 years of regulatory affairs experience in the pharmaceutical...

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7.0 - 10.0 years

0 Lacs

thane, maharashtra, india

On-site

Job Description Are You Ready to Make It Happen at Mondel?z International Join our Mission to Lead the Future of Snacking. Make It With Pride. You execute the regulatory affairs strategy for your respective category or categories and geographical area using your technical and regulatory knowledge. You ensure our policies, regulatory programs and requirements of our portfolio carried out. How you will contribute You will deliver on the regulatory affairs strategy and compliance agenda and work with cross-functional stakeholders to assess regulatory business risks and opportunities. You will provide regulatory affairs expertise for technical regulatory developments and help in responses to cha...

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8.0 - 12.0 years

9 - 13 Lacs

hyderabad

Work from Office

Seeking a Senior Firewall Resource (L2-MS) to join our SAP Hyperscaler Engineering Services team. Key responsibilities include managing firewall configurations, troubleshooting, and ensuring network security in a cloud environment. Candidate should have experience with SAP systems, specifically in an MS environment, and expertise in CIS MS India. Ability to collaborate across teams and optimize firewall solutions for SAP environments. Location: Hyderabad, subcontractor position.

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10.0 - 18.0 years

20 - 35 Lacs

gurugram

Work from Office

Job Description: Head QARA Medical devices Location: Gurugram, India Job Overview The RAQA Manager will lead regulatory compliance and quality management activities for disposable and electromechanical devices used in endoscopy and urology , including Class I, Class II, and Class III medical devices . The role ensures adherence to global regulatory requirements (EU MDR, US FDA 21 CFR, ISO standards, etc.), oversees product registrations, and maintains robust quality systems aligned with ISO 13485 , IEC 60601 , IEC 62304 , and related standards. Key Responsibilities Regulatory Affairs Develop and implement regulatory strategies for new disposable and electro mechanical devices across Class II...

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