10+ Regulatory affairs Jobs in India

Job Summary:

We are seeking an experienced and detail-oriented Senior Manager – Quality Assurance & Regulatory Affairs to lead and oversee all quality and regulatory functions within our company.

This role requires in-depth knowledge of industry standards, regulatory frameworks, and manufacturing best practices, ensuring that products meet safety, efficacy, and compliance requirements across global markets.

Key Responsibilities:

Quality Assurance (QA):

• Develop, implement, and manage the Quality Management System (QMS) in compliance with ISO, GMP, and other applicable standards.

• Oversee quality audits (internal and external) and ensure timely closure of non-conformities.

• Lead QA initiatives throughout the product lifecycle—from R&D to production to market release.

• Review and approve SOPs, batch records, and change control documentation.

• Ensure quality assurance processes align with manufacturing and packaging operations to maintain product integrity.

• Monitor and manage deviations, CAPAs (Corrective and Preventive Actions), and risk assessments.

• Coordinate with production and R&D teams for validation and stability studies. Regulatory Affairs (RA):

• Ensure product compliance with national and international regulatory standards (e.g., FDA, EU Cosmetics Regulation, BIS, CDSCO, ASEAN, etc.).

• Prepare and submit dossiers for product registration and licensing in various geographies.

• Maintain regulatory intelligence and advise the business on upcoming regulatory changes affecting products.

• Handle labelling compliance, ingredient review, and claims substantiation as per regulatory norms.

• Act as the regulatory liaison with government bodies, external auditors, and certification agencies.

• Maintain all necessary documentation and technical files for regulatory audits and inspections. Team Leadership & Cross-Functional Collaboration:

• Lead and mentor the QA & RA teams, driving continuous improvement and knowledge sharing.

• Collaborate with R&D, Manufacturing, Marketing, and Legal teams to ensure regulatory and quality alignment at all stages of product development and launch.

• Support expansion by facilitating regulatory approval processes in target markets.

Required Qualifications & Skills:

• Bachelor’s or Master’s degree in Pharmacy, Cosmetic Technology, Chemistry, or related field.

• 10–15 years of experience in the skincare/cosmetic industry, with a strong background in QA and Regulatory Affairs.

• In-depth understanding of cosmetic regulations (India, EU, US, Middle East, Southeast Asia, etc.).

• Strong leadership, organizational, and communication skills.

• Hands-on experience with regulatory submissions, audits, and compliance strategy.

• Detail-oriented with the ability to manage multiple projects and deadlines.

Preferred:

• Experience working with natural/organic skincare & cosmetic product lines.

• Certifications in ISO 22716 (GMP for cosmetics), ISO 9001, or similar quality systems.

• Familiarity with product safety assessments, microbiological testing, and toxicology reports

About Antier Solutions

Antier Solutions is a global leader in blockchain, DeFi, and tokenization, driving regulatory-compliant Web3 innovations. As the industry evolves, ensuring legal and regulatory compliance is critical for sustainable growth.

We are looking for a General Counsel / Head of Crypto Compliance & Regulatory Affairs (initially outsourced) to lead compliance for token launches, fundraising, and Web3 business models while working with global regulatory bodies.

This is a high-impact role, perfect for an expert in crypto law, fintech regulations, and international securities compliance.

Role Overview

As the General Counsel / Head of Crypto Compliance, you will:

✔ Oversee regulatory compliance for token sales, fundraising, and Web3 projects.

✔ Liaise with global regulators (SEC, MAS, ESMA, DIFC, FCA, etc.) to ensure licensing and structuring.

✔ Ensure adherence to AML/KYC, investor protections, and jurisdiction-specific legal frameworks.

✔ Mitigate legal risks associated with crypto exchanges, DeFi protocols, and NFT marketplaces.

✔ Develop internal legal policies to align with global securities, tax, and financial regulations.

Key Responsibilities

1. Legal & Regulatory Compliance for Web3 & Token Launches

• Ensure full compliance for ICOs, IDOs, STOs, and private token sales.
• Provide regulatory guidance on structuring utility vs. security tokens.
• Work with securities and financial regulators to ensure legally compliant fundraising mechanisms.
• Assess and mitigate legal risks related to smart contracts, tokenomics, and DAOs.

2. Global Licensing & Regulatory Affairs

• Work with SEC (USA), MAS (Singapore), FCA (UK), ESMA (Europe), and DIFC (Dubai) on crypto licensing & approvals.
• Support the acquisition of Virtual Asset Service Provider (VASP) licenses in multiple jurisdictions.
• Develop cross-border compliance strategies for international Web3 operations.

3. AML/KYC, Investor Protection & Jurisdictional Compliance

• Oversee AML (Anti-Money Laundering) & KYC (Know Your Customer) policies for token sales & DeFi platforms.
• Ensure compliance with FATF Travel Rule, GDPR, and data privacy laws in crypto transactions.
• Implement investor protection mechanisms to comply with securities and exchange laws.

4. Risk Management & Smart Contract Legal Audits

• Conduct legal due diligence on Web3 projects before fundraising rounds.
• Work with blockchain developers to audit smart contracts for legal risks.
• Establish corporate governance frameworks for DAOs and decentralized projects.

5. Internal Legal Advisory & Policy Development

• Draft terms of service, privacy policies, and compliance documentation for blockchain platforms.
• Provide legal counsel on intellectual property rights for NFTs and metaverse projects.
• Advise the executive team on emerging regulatory changes affecting the crypto industry.

Key Qualifications & Experience

Must-Have:

✅ 5-10+ years in crypto/fintech law, regulatory compliance, or legal advisory.

✅ Deep understanding of crypto regulations, securities law, and DeFi compliance.

✅ Experience working with global regulatory bodies (SEC, MAS, FCA, ESMA, DIFC, etc.).

✅ Expertise in AML/KYC frameworks, FATF Travel Rule, and investor protection laws.

✅ Familiarity with token classifications (security vs. utility) and Web3 fundraising structures.

Preferred:

• Experience with VASP licensing, DAO governance, and smart contract legal audits.
• Strong connections with global law firms, compliance officers, and financial regulators.
• Understanding of cross-border tax implications for digital assets and stablecoins.
• Prior involvement in legal structuring for blockchain startups and crypto exchanges.

Why Join Antier Solutions?

🚀 Lead compliance for cutting-edge Web3 projects in a legally evolving industry.

🌍 Work with top-tier regulators, VCs, and blockchain pioneers.

💰 Shape tokenomics models and investor protections for high-growth crypto ventures.

🤝 Be part of a global blockchain consultancy driving regulatory excellence.

Job Title : Information Management (IM) Advisor – Data Controller

Job Overview :

The IM Advisor (Data Controller) will serve as the primary liaison between business and IT, ensuring best practices in Information Management (IM) solutions, compliance, and data governance.

This role involves designing and delivering IM solutions, ensuring compliance with IM standards, and driving awareness within the organization.

Key Responsibilities :

• Act as the first point of contact for Information Management, advising business teams on best practices and compliance.
• Implement and maintain control systems, procedures, and data validation processes for engineering data warehouses (EDW).
• Collaborate with contractors to ensure data consistency, validation, and integration into central repositories.
• Drive compliance with IM standards, data privacy regulations, and other legal requirements.
• Monitor and improve IM processes, ensuring efficient data handover and control mechanisms.
• Develop and manage data control procedures for projects, ensuring seamless transition to operations.
• Provide IM training to end users and manage offshore data support services.

Key Skills & Qualifications :

• Experience : 3-10 Years in data control on major capital projects, with EPC interface management.
• Technical Expertise :
• Engineering databases, SharePoint, and document management systems.
• Experience with Engineering Data Warehouses (SPF, AVEVA, AIM, ALIM).
• Reporting tools (Power BI, Tableau).
• Knowledge of engineering IM scope, data modeling, and maintenance processes.
• Compliance & Governance : Knowledge of GDPR, security, privacy, and IM best practices.
• Leadership & Communication : Strong interpersonal skills, global stakeholder engagement, and ability to manage multiple projects.
• Technology Awareness : Familiarity with RPA, AI, Blockchain, and machine learning in IM processes.

Preferred Qualifications:

• Previous experience with Shell or similar organizations.
• Knowledge of Agile methodologies and Continuous Improvement practices.

Designation: Financial Manager 

• Exp: 8-10 Years
• CTC: up tp 30 LPA

Regulatory, Contractual & US Healthcare compliances:

• Ensure compliance to HIPAA & Hi-Tech requirements framework through audits, policy updates, external certifications, internal awareness, etc.
• Periodically update policies and document new procedures / guidelines to update the compliance plan in line with operating changes.
• Work with legal & training teams to drive the compliance programs for awareness and update of important US healthcare regulations as applicable to business.
• Work with VP, Finance, HR & Legal team across all locations to consolidate & present the compliance to regulatory requirements periodically to LT and Audit Committee.
• Update the customer contractual checklists and monitor compliance to same through periodic reviews
• Train the team on compliance programs to deliver standard compliance experience across the locations.
• Enterprise risk management (ERM), Management reviews, Investigations & Internal Audits

Cab Boundary line- 

• Navi Mumbai to Ghatkopar
• Navi Mumbai to Panvel (Ulwe not covered)
• Navi Mumbai to Kalyan

Job Purpose:

The role entails the responsibility to be a part of IT Governance and Compliance Team of the bank and would be working towards GRC control function: Compliance & Regulatory reporting viz Cyber KRI, TRANCHE, ICAAP etc.

Roles & Responsibilities:

• Custodian of IT governance and IT process governance framework.
• Handling of Regulatory audits and submissions.
• To understand Indents from regulators, collated, review the data and timely submission.
• Responsible for IT policy creation, review, update, awareness, and monitoring.
• Administration of key IT processes: E.g., incident management, policy exception management
• Will be reporting to Lead IT Governance.
• Identify improvements and breakdowns in IT governance elements with significant business impact.
• Create and maintain library of governance artifacts and other supporting documentation.
• Proactively identify and manage risks/issues, ensure proper visibility and communication occur to senior management.
• Ensures compliance with all policies and procedures in the execution of technology projects.
• Provide guidance and trainings to Project team members in the field regarding IT governance.
• Capture and share best- practice knowledge amongst the team.
• Create an environment that promotes collaborative learning and collective ownership of responsibilities.
• Strong analytical and problem-solving skills. Excellent communication and interpersonal abilities.
• Ability to work independently and collaborate effectively in a team environment.

Education Qualification (Fulltime): 

Certified Chartered Accountant (CA)

REQUIRE QUALITY ASSURANCE EXECUTIVE

EDUCATION – GRADUATE- BSC/BPHARMA

SKILLS- QA, TESTING KNOWLEDGE, REGULATORY AFFAIRS,

EXPERIENCE – MIN 3 YEARS IN PHARMA

SALARY – UPTO 35K

Job Title: QA Associate 

Job Description:

1. Responsible for Implementing, controlling and monitoring quality management system documentation (ISO 27001) and data privacy (SOC2).
2. Coordinate improvement in the system through output from audit, management review, and responsible to close NC’s during audits.
3. Knowledge of SAMD (Software as Medical Device) SaaS product, processes and procedures.

3-5 years of relevant experience in Medical Devices Industry.

Area of Expertise:

• To generate, implement and maintain internal quality procedures and systems to comply with ISO 27001, SOC2 standards
• Maintaining and updating various documents like internal docs log, external log, , Obsolete docs log, DCN, ECN, CAPA, SQA/IQA log, product complaint, equipment log
• Maintaining Engineering documents like part specs, Bill of materials, Drawings, Design review documents etc
• Co-ordinate and conduct periodic internal audits of various functional groups of an organization and drive compliance to QMS.
• Manage all documentation related to internal and external audit.
• Manage all the documents related to supplier qualification and coordinate Supplier’s audit and maintain the supplier file.
• Experience in Handling of CAPA (Corrective & Preventive Actions) & Product Complaints
• Co-ordination of Management Review Meetings & its action items implementation

Experience Required:

• 3-5 years of relevant experience in Medical Devices Industry.
• Educational Qualification – Diploma/Engineering graduate, preferably Computer Science or related.
• Ability to read and understand standard requirements independently.
• Good teamwork, communication and interpersonal skills. A demonstrated commitment to company values
• Good understanding of design control, and post marketing processes
• Knowledge of FDA / EU / Indian & other national regulations is an added advantage.
• Working knowledge of an e-QMS is an added advantage.

• Support the transition by planning and overseeing the transfer of members from one location to another, including but not limited to operational readiness, support documentation, knowledge transfer and acceptance checklists
• Support in ensuring transition activity is planned and executed to schedule, budget and scope
• Support in establishing transition end to end plans including infrastructure support models, change management, risk assessment and mitigation, resource planning and service management with clear tollgates
• Liaise with transition lead on milestone scheduling, knowledge transfer activities, and communication of progress (KPIs)
• Keep stakeholders involved in transition process and update them with the progress and roadblocks
• Promote awareness of transition planning and support processes within the GCC
• Support the Transition Lead to source and assess opportunities to expand the centre (including assessment of Make vs. Buy, offshore / on shore)
• Work directly with third party resources on a day-to-day basis to support the transition process during the set-up of the GCC

Skills:

• Proven knowledge of service transition methodology, tools and templates through experience or qualifications
• The ability to identify, escalate and manage project risks with the Transition Lead
• 3+ years of experience transitioning / offshoring / outsourcing projects / functions across sub processes such as Biostatistics, reg. affairs, clinical ops, drug safety, medical Governance, strategy and planning, pharma covigilance
• Good exposure in previous roles to multi-cultural, transversal functions
• Pharma background with experience across the systems development life cycle with experience in different project phases
• Excellent written and verbal communication skills – must be able to communicate fluently in English both verbally and in writing