3,206 Regulatory Compliance jobs in India
Regulatory Compliance Specialist
Posted today
Job Viewed
Job Description
The Regulatory Compliance Specialist is a key position in the Regulatory Compliance organization. This position drives the daily compliance activities required under the company's trade compliance policy. The Regulatory Compliance Specialist is primarily responsible for resolving potential DPL matches and work with stakeholders that these are not exact matches. This position also reviews compliance holds relative to strategic or controlled goods and based on the nature of end-customers, determines whether a license or government authorization is required to make the sale or the export. This position is involved in conducting risk assessment of end-customers and categorize them accordingly based on a defined criterion. The Regulatory Compliance Specialist is responsible for analyzing metrics that track turnaround times in reviewing and releasing DPC and ECCN holds. Minimum supervision is required for this role.
Responsibilities:Address DPC escalations relating to potential matches when screening new customers, vendors or subcons.
Assist in determining the in-country HS codes for articles created in SAP system.
Perform ECCN review and determine license/regulatory requirements for all sales transactions.
Extract report from SAP system for DPC and ECCN Hold Metrics per month. Analyze metrics & determine actions further improve turnaround time or reduce DPC holds.
Prepare other trade compliance reports as required by the department.
Perform risk assessments on end-customers and categorize them according to a pre-determined criterion.
Perform ECCN validation of new articles created in SAP.
Knowledge, Skills and Experience:
3 to 5 Years of relevant work experience.
Associate degree with International Trade or Logistics field of study required.
Minimum Diploma in International Trade or Logistics or Supply Chain
Able to execute instructions and to request clarification when needed.
Able to use a 10-key quickly and accurately.
Possesses basic clerical and data entry skills.
Possesses strong data entry skills.
Able to recognize and attend to important details with accuracy and efficiency.
Able to communicate clearly and convey necessary information.
Able to converse and write effectively in English.
Possesses strong multi-cultural interpersonal skills.
Able to constructively work under stress and pressure when faced with high workloads and deadlines.
Able to maintain and promote social, ethical, and organizational standards in conducting internal and external business activities.
Able to work independently with minimum supervision.
Able to maintain confidentiality of sensitive information.
Able to build solid, effective working relationships with others.
Able to exhibit ability to be sensitive to the needs, concerns, and feelings of others.
Able to quickly learn new systems and technology.
Consistent non-standard work or overtime as business requires.
On-call availability required as necessary.
Professional, office environment.
Full-time working week with some work hours flexibility expected.
What’s In It For You?
- Elective Benefits: Our programs are tailored to your country to best accommodate your lifestyle.
- Grow Your Career: Accelerate your path to success (and keep up with the future) with formal programs on leadership and professional development, and many more on-demand courses.
- Elevate Your Personal Well-Being: Boost your financial, physical, and mental well-being through seminars, events, and our global Life Empowerment Assistance Program.
- Diversity, Equity & Inclusion: It’s not just a phrase to us; valuing every voice is how we succeed. Join us in celebrating our global diversity through inclusive education, meaningful peer-to-peer conversations, and equitable growth and development opportunities.
- Make the Most of our Global Organization : Network with other new co-workers within your first 30 days through our onboarding program.
- Connect with Your Community: Participate in internal, peer-led inclusive communities and activities, including business resource groups, local volunteering events, and more environmental and social initiatives.
Regulatory Compliance Specialist
Posted today
Job Viewed
Job Description
The Regulatory Compliance Specialist is a key position in the Regulatory Compliance organization. This position drives the daily compliance activities required under the company's trade compliance policy. The Regulatory Compliance Specialist is primarily responsible for resolving potential DPL matches and work with stakeholders that these are not exact matches. This position also reviews compliance holds relative to strategic or controlled goods and based on the nature of end-customers, determines whether a license or government authorization is required to make the sale or the export. This position is involved in conducting risk assessment of end-customers and categorize them accordingly based on a defined criterion. The Regulatory Compliance Specialist is responsible for analyzing metrics that track turnaround times in reviewing and releasing DPC and ECCN holds. Minimum supervision is required for this role.
Responsibilities:Address DPC escalations relating to potential matches when screening new customers, vendors or subcons.
Assist in determining the in-country HS codes for articles created in SAP system.
Perform ECCN review and determine license/regulatory requirements for all sales transactions.
Extract report from SAP system for DPC and ECCN Hold Metrics per month. Analyze metrics & determine actions further improve turnaround time or reduce DPC holds.
Prepare other trade compliance reports as required by the department.
Perform risk assessments on end-customers and categorize them according to a pre-determined criterion.
Perform ECCN validation of new articles created in SAP.
Knowledge, Skills and Experience:
3 to 5 Years of relevant work experience.
Associate degree with International Trade or Logistics field of study required.
Minimum Diploma in International Trade or Logistics or Supply Chain
Able to execute instructions and to request clarification when needed.
Able to use a 10-key quickly and accurately.
Possesses basic clerical and data entry skills.
Possesses strong data entry skills.
Able to recognize and attend to important details with accuracy and efficiency.
Able to communicate clearly and convey necessary information.
Able to converse and write effectively in English.
Possesses strong multi-cultural interpersonal skills.
Able to constructively work under stress and pressure when faced with high workloads and deadlines.
Able to maintain and promote social, ethical, and organizational standards in conducting internal and external business activities.
Able to work independently with minimum supervision.
Able to maintain confidentiality of sensitive information.
Able to build solid, effective working relationships with others.
Able to exhibit ability to be sensitive to the needs, concerns, and feelings of others.
Able to quickly learn new systems and technology.
Consistent non-standard work or overtime as business requires.
On-call availability required as necessary.
Professional, office environment.
Full-time working week with some work hours flexibility expected.
What’s In It For You?
- Elective Benefits: Our programs are tailored to your country to best accommodate your lifestyle.
- Grow Your Career: Accelerate your path to success (and keep up with the future) with formal programs on leadership and professional development, and many more on-demand courses.
- Elevate Your Personal Well-Being: Boost your financial, physical, and mental well-being through seminars, events, and our global Life Empowerment Assistance Program.
- Diversity, Equity & Inclusion: It’s not just a phrase to us; valuing every voice is how we succeed. Join us in celebrating our global diversity through inclusive education, meaningful peer-to-peer conversations, and equitable growth and development opportunities.
- Make the Most of our Global Organization : Network with other new co-workers within your first 30 days through our onboarding program.
- Connect with Your Community: Participate in internal, peer-led inclusive communities and activities, including business resource groups, local volunteering events, and more environmental and social initiatives.
Regulatory & Compliance specialist – Exports
Posted today
Job Viewed
Job Description
About Elchemy Elchemy is a tech-enabled cross-border specialty chemicals marketplace.
Our vision is to become the largest global speciality chemicals distributor focussing on discovery and fulfillment using a tech-first approach. Chemicals is an extremely important large and fragmented market with multiple inefficiencies in cross border trade.
The global speciality chemicals market is $800bn growing at a CAGR of 5.7%.
The industry faces glaring challenges including lack of trust, excessive lead times, quality uncertainty, lack of transparency and tons of operational challenges.
In the past 20 months of the company's operation, we have scaled up our operations serving in more than 32 countries and have active partnerships with more than 100s of customers and suppliers.
The company has raised a total of upwards of $7.5mn from marquee investors like InfoEdge Ventures, Prime Venture Partners and from promoters of companies like Vinati Organics, Laxmi Organics, and Coromandel International.
Our highly ambitious team comprises alumni from IITs, IIMs, NITs and have extensive experience of working in startups as well as multinational companies.
We want to create a team with A-players and rockstars in all roles.
When such a team comes together, no vision seems unachievable, and everyone pushes to deliver outstanding results. Roles and Responsibilities: Ensure full compliance with domestic and international export regulations (DGFT, BIS, REACH, FDA etc.) Review and correct Technical Data Sheets (TDSs) and Safety Data Sheets (SDSs) manually to meet regulatory standards.
Maintain up-to-date export documentation, licensing, and customs paperwork .
Handle trademark registrations, brand names, and labeling compliance across different markets.
Ensure that export labels meet international standards and regulatory requirements.
Conduct internal audits to ensure documentation accuracy and compliance.
Handle trademark registrations, renewals, and disputes to protect intellectual property Ensure product labels, barcodes, and packaging comply with regulatory requirements for different markets (EU, US, Asia, etc.).
Prior experience in manually reviewing and correcting TDSs, SDSs, and export documentation .
Strong knowledge of global export regulations, IPR laws, and trade compliance .
Hands-on experience with MSDS/TDS documentation, international labeling laws, and customs documentation .
Excellent communication and coordination skills Action-oriented with a willingness to be hands-on in sourcing operations.
Entrepreneurial mindset, strong business acumen, and an extensive professional network.
Commitment to the mission with a sense of ownership and passion.
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Regulatory Compliance

Posted 7 days ago
Job Viewed
Job Description
To lead and manage all regulatory affairs activities at the manufacturing site located at Mumbai and LL locations, ensuring timely regulatory submissions, compliance with regulations, and providing strategic support to institutional and international business operations. The role is critical to maintaining business continuity and regulatory compliance.
**Core Job Responsibilities:**
**Regulatory Submissions and compliance**
+ Prepare and submit various applications such as additional product permission, Layout approval, facility modification approval, technical person approval, Test license, amendments in licenses, State GMP and GLP certificate applications, post approval changes etc. to State FDA
+ Prepare and submit applications such as Test license NOC, WHO GMP applications, CPP applications for additional products.
+ Ensure timely submissions and approvals for all regulatory filings.
+ Evaluate technical and scientific data for regulatory submissions.
+ Liaise with health authorities for inspections, clarifications, and approvals.
+ Ensure compliance with D&C Act, NDPS Act, Gazette Notifications, and internal SOPs.
**Product & Business Support**
+ Handle product complaints from regulatory authorities, coordinating with QA, Legal, SCM, and Manufacturing for resolution.
+ Provide regulatory support for internalization and externalization of products.
+ To provide site CMC documents to international business team to support export registration.
**Documentation & Quality Oversight**
+ Maintain and update regulatory databases, trackers, licenses, and approvals.
+ Review and track regulatory impact of quality documents such as change controls, deviations, FLQRs, and product certifications.
+ Evaluate and approve site change controls and Change Request evaluation forms.
+ Provide working standards/specifications and CoAs to regulatory authorities and internal teams.
**Tender Certificates**
+ To obtain NCC, Manufacturing & Marketing Certificates, and CMC documents to support institutional and international business.
+ Coordinate with Institutional business team and site team for documentation as well as to facilitate site inspection of tendering authority.
**Governance, SOPs & Training**
+ Support the preparation, revision, and implementation of Regulatory SOPs and work instructions.
+ Deliver training on GMP, regulatory updates, and SOPs at the site level.
+ Approve SCNs from Corporate QA and review reports from regulatory authorities.
**Additional Responsibilities**
+ Complete assigned trainings on time
+ Perform other duties as assigned by the Regulatory Affairs leadership.
+ Act as the regulatory lead for the site, ensuring alignment with corporate and regulatory expectations.
**Position Accountability/Scope:**
+ ·Responsible for all regulatory activities for the manufacturing site mainly LL sites.
+ ·Ensures site compliance with applicable national regulations and Abbott standards.
+ Supports business continuity through proactive regulatory planning and execution.
**Minimum Education:**
B.Pharm / M.Pharm / M.Sc. or equivalent in pharmaceutical or life sciences discipline.
**Minimum Experience/Training Required:**
+ **Manager:** Minimum 08 - 12 years of experience in Regulatory Affairs preferably with a multinational or leading Indian pharmaceutical company. Prior experience in Quality Assurance is desirable.
+ Familiarity with regulatory platforms (SUGAM, ONDLS, NSWS, SolTRAQs) is desirable.
An Equal Opportunity Employer
Abbot welcomes and encourages diversity in our workforce.
We provide reasonable accommodation to qualified individuals with disabilities.
To request accommodation, please call or email
Regulatory Compliance
Posted today
Job Viewed
Job Description
Primary Job Function:
To lead and manage all regulatory affairs activities at the manufacturing site located at Mumbai and LL locations, ensuring timely regulatory submissions, compliance with regulations, and providing strategic support to institutional and international business operations. The role is critical to maintaining business continuity and regulatory compliance.
Core Job Responsibilities:
Regulatory Submissions and compliancePosition Accountability/Scope:
Minimum Education:
B.Pharm / M.Pharm / M.Sc. or equivalent in pharmaceutical or life sciences discipline.
Minimum Experience/Training Required:
RC - REGULATORY COMPLIANCE - REGULATORY COMPLIANCE - Senior
Posted today
Job Viewed
Job Description
The opportunity
We’re looking for Senior with expertise in Computer System Validation and stakeholder management to join our EY-Regulatory Compliance team. This is a fantastic opportunity to be part of a leading firm whilst being instrumental in the growth of emerging service offering.
Your key responsibilities
Skills and attributes for success
To qualify for the role, you must have
Ideally, you’ll also have
What we look for
What working at EY offers
At EY, we’re dedicated to helping our clients, from start–ups to Fortune 500 companies — and the work we do with them is as varied as they are.
You get to work with inspiring and meaningful projects. Our focus is education and coaching alongside practical experience to ensure your personal development. We value our employees and you will be able to control your own development with an individual progression plan. You will quickly grow into a responsible role with challenging and stimulating assignments. Moreover, you will be part of an interdisciplinary environment that emphasizes high quality and knowledge exchange. Plus, we offer:
EY | Building a better working world
RC-REGULATORY COMPLIANCE-REGULATORY COMPLIANCE-Manager
Posted today
Job Viewed
Job Description
The opportunity
We’re looking for Manager with expertise in Computer System Validation and Stakeholder Management to join the leadership group of our EY-Regulatory Compliance team. This is a fantastic opportunity to be part of a leading firm whilst being instrumental in the growth of emerging service offering.
Your key responsibilities
Skills and attributes for success
Governance and reporting
Knowledge of Incident Management, Change Management, Periodic Review, Vendor Management, Quality Management Review procedures.
Strong Knowledge on authoring and review of Validation Deliverables such as Validation Plan & report, Requirement specifications, Risk Analysis, Qualification Protocols & reports, Test Scripts, Traceability Matrix etc.
Has supported Audits / Inspections
To qualify for the role, you must have
Ideally, you’ll also have
What we look for
A Team of people with commercial acumen, technical experience and enthusiasm to learn new things in this fast-moving environment with consulting skills.
An opportunity to be a part of market-leading, multi-disciplinary team of 1400 + professionals, in the only integrated global transaction business worldwide.
Opportunities to work with EY Consulting practices globally with leading businesses across a range of industries
What working at EY offers
At EY, we’re dedicated to helping our clients, from start–ups to Fortune 500 companies — and the work we do with them is as varied as they are.
You get to work with inspiring and meaningful projects. Our focus is education and coaching alongside practical experience to ensure your personal development. We value our employees and you will be able to control your own development with an individual progression plan. You will quickly grow into a responsible role with challenging and stimulating assignments. Moreover, you will be part of an interdisciplinary environment that emphasizes high quality and knowledge exchange. Plus, we offer:
EY | Building a better working world
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RC - REGULATORY COMPLIANCE - REGULATORY COMPLIANCE - Senior
Posted today
Job Viewed
Job Description
The opportunity
We’re looking for Senior with expertise in Computer System Validation and stakeholder management to join our EY-Regulatory Compliance team. This is a fantastic opportunity to be part of a leading firm whilst being instrumental in the growth of emerging service offering.
Your key responsibilities
Skills and attributes for success
To qualify for the role, you must have
Ideally, you’ll also have
What we look for
What working at EY offers
At EY, we’re dedicated to helping our clients, from start–ups to Fortune 500 companies — and the work we do with them is as varied as they are.
You get to work with inspiring and meaningful projects. Our focus is education and coaching alongside practical experience to ensure your personal development. We value our employees and you will be able to control your own development with an individual progression plan. You will quickly grow into a responsible role with challenging and stimulating assignments. Moreover, you will be part of an interdisciplinary environment that emphasizes high quality and knowledge exchange. Plus, we offer:
EY | Building a better working world
RC-REGULATORY COMPLIANCE-REGULATORY COMPLIANCE-Manager
Posted today
Job Viewed
Job Description
The opportunity
We’re looking for Manager with expertise in Computer System Validation and Stakeholder Management to join the leadership group of our EY-Regulatory Compliance team. This is a fantastic opportunity to be part of a leading firm whilst being instrumental in the growth of emerging service offering.
Your key responsibilities
Skills and attributes for success
T o qualify for the role, you must have
Ideally, you’ll also have
What we look for
What working at EY offers
At EY, we’re dedicated to helping our clients, from start–ups to Fortune 500 companies — and the work we do with them is as varied as they are.
You get to work with inspiring and meaningful projects. Our focus is education and coaching alongside practical experience to ensure your personal development. We value our employees and you will be able to control your own development with an individual progression plan. You will quickly grow into a responsible role with challenging and stimulating assignments. Moreover, you will be part of an interdisciplinary environment that emphasizes high quality and knowledge exchange. Plus, we offer:
EY | Building a better working world
RC-REGULATORY COMPLIANCE-REGULATORY COMPLIANCE-Senior
Posted today
Job Viewed
Job Description
The opportunity
We’re looking for Senior with expertise in Computer System Validation and stakeholder management to join our EY-Regulatory Compliance team. This is a fantastic opportunity to be part of a leading firm whilst being instrumental in the growth of emerging service offering.
Your key responsibilities
Skills and attributes for success
To qualify for the role, you must have
Ideally, you’ll also have
What we look for
What working at EY offers
At EY, we’re dedicated to helping our clients, from start–ups to Fortune 500 companies — and the work we do with them is as varied as they are.
You get to work with inspiring and meaningful projects. Our focus is education and coaching alongside practical experience to ensure your personal development. We value our employees and you will be able to control your own development with an individual progression plan. You will quickly grow into a responsible role with challenging and stimulating assignments. Moreover, you will be part of an interdisciplinary environment that emphasizes high quality and knowledge exchange. Plus, we offer:
EY | Building a better working world