1,070 Regulatory Affairs Consultant jobs in India
Regulatory Affairs Consultant (Biologics/Small Molecules)

Posted 5 days ago
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+ Good understanding of regulatory framework, including regional trends, for various types of applications and procedures.
+ Lead and / or contribute to the planning, preparation, authoring and delivery of regulatory maintenance submissions from either a global and/or regional perspective.
+ Responsible for managing (Authoring and Review) of biosimilar investigational product submission such as IND & IMPD for USFDA, EMA
+ Authoring, review, and submission of BLA/MAA of biosimilar dossiers for US/EU/ROW /India markets.
+ Preparation / Review of Regulatory gap analysis and strategy documents (with remediation plans for identified gaps) for submissions like IND, IMPD, DMF, BLA, NDA, and MAA applications.
+ Life cycle management (LCM) for approved products. (Annual reports, variations, renewals) for Europe (Type IA/IB/II/IAIN) / US and other ROW markets.
+ Evaluation of change controls and deviations and defining regulatory strategy .
+ Co-ordination with internal and external stake holders for documentation required for filing. Identify quality and/or timeliness issues with source documents, as early as possible
+ Develop up-to-date knowledge about regulatory guideline updates and applies regulatory requirements and their impact on submissions.
+ Working experience in Regulatory Information Management Systems like Veeva Vault.
+ Strong communications skills and ability to guide and mentor team members.
+ Ability to work independently.
+ Review and submit safety variations to Health Authorities and perform post Approval CMC / labeling related updates.
+ Authoring content of the label (EU, Canada, AU/NZ & US) based on Company Core Data Sheet (CCDS) / PRAC / CMDH recommendations.
+ Familiarity with EU Guidelines for QRD / Excipients.
+ Artwork management for countries with label in English.
EEO Disclaimer
Parexel is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to legally protected status, which in the US includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.
Regulatory Affairs Consultant (Biologics/Small Molecules)
Posted today
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When our values align, there's no limit to what we can achieve.
Graduate Trainee - Legal Affairs
Posted today
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This role is perfect for individuals eager to launch their legal careers and develop a strong foundation. You will assist in drafting legal documents, conducting legal research on various statutes and case laws, reviewing contracts, and maintaining legal records. Furthermore, you will have the chance to observe and participate in internal legal discussions, learn about compliance procedures, and gain insight into the legal challenges faced by organizations. We are looking for candidates who are detail-oriented, possess strong analytical and communication skills, and demonstrate a proactive approach to learning. The ability to manage time effectively and work collaboratively in a virtual setting is essential.
Responsibilities:
- Assist in conducting legal research using various databases and resources.
- Support the drafting and reviewing of legal documents, agreements, and correspondence.
- Help maintain and organize legal files, records, and databases.
- Assist in preparing reports and presentations for the legal department.
- Participate in team meetings and contribute to discussions.
- Monitor legal developments and update team members on relevant changes.
- Ensure compliance with internal policies and external regulations.
- Provide administrative support to the legal team as needed.
- Recent LLB or equivalent law degree from a recognized university.
- Strong academic record.
- Excellent legal research and analytical skills.
- Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint).
- Familiarity with legal databases and research tools.
- Outstanding written and verbal communication skills.
- Ability to work independently, manage time effectively, and meet deadlines in a remote setting.
- Proactive attitude, willingness to learn, and strong work ethic.
- Enthusiasm for a career in corporate law or related fields.
Job Opportunity in Legal Affairs
Posted today
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Legal Education and Training
Leverage expert-led courses to equip yourself with real-world skills for success in the evolving legal industry.
This includes practical training on:
- Assisting with research and analysis of legal documents
- Preparing and drafting contracts, agreements, and other legal documents
- Consulting on complex legal issues, such as torts and contract law
- Communicating findings and updates effectively to clients and stakeholders
Key qualifications include:
- Enrollment in a law program or equivalent degree
- Experience in legal writing, consulting, and research
- Strong knowledge of law and legal issues, including ethics and professional responsibility
- Ability to conduct thorough research and analysis of legal cases and documents
- Detail-oriented with strong organisational skills, able to manage multiple projects and deadlines
- Effective communication and interpersonal skills, with ability to work collaboratively with others
Successful candidates will be able to work independently, remotely, and meet tight deadlines while maintaining high levels of productivity and quality.
Lead Consultant - Regulatory Affairs
Posted today
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Ready to build the future with AI?
At Genpact, we don’t just keep up with technology—we set the pace. AI and digital innovation are redefining industries, and we’re leading the charge. Genpact’s AI Gigafactory, our industry-first accelerator, is an example of how we’re scaling advanced technology solutions to help global enterprises work smarter, grow faster, and transform at scale. From large-scale models to agentic AI, our breakthrough solutions tackle companies’ most complex challenges.
If you thrive in a fast-moving, innovation-driven environment, love building and deploying cutting-edge AI solutions, and want to push the boundaries of what’s possible, this is your moment.
Genpact (NYSE: G) is an advanced technology services and solutions company that delivers lasting value for leading enterprises globally. Through our deep business knowledge, operational excellence, and cutting-edge solutions – we help companies across industries get ahead and stay ahead. Powered by curiosity, courage, and innovation, our teams implement data, technology, and AI to create tomorrow, today. Get to know us at genpact.com and on LinkedIn, X, YouTube, and Facebook.
Inviting applications for the role of Management Trainee/ Assistant Manager- Lead Associate or Lead Consultant, Regulatory affairs.
Responsible for implementing CMC regulatory strategies for assigned pharmaceutical products in accordance with global regulations, guidance and defined regulatory strategies along with the preparation and review of information required for development of regulatory CMC dossiers for commercial products.
Responsibilities:
• The core responsibility will be to review the authored documents, compare them with source documents, ensure there are no transcription or formatting errors, no quality errors, and ensure compliance with regulatory guidelines.
• Maintaining the quality of documents through quality reviews ensuring “No Queries” received from Health Authorities
• Work on authoring CMC documentation for worldwide marketing of pharmaceutical products for initial registration and life-cycle management under the direction of team scientists.
• Experience in reviewing scientific information to assess technical merits and suitability of scientific rationale to ensure information is presented clearly and conclusions are adequately supported by data.
• Able to prioritize & execute the project according to the project plan/timelines/schedules.
• Work with cross-functional teams to track and follow up outstanding documentation, coordinate on project status & reporting to stakeholders using different communication channels.
• Demonstrated oral and written communication skills and the ability to communicate issues in a succinct and logical manner. Strong listening skills.
• Demonstrated understanding of related fields (e.g., pharmaceutical manufacturing, analytical testing, and quality assurance).
• Ability to generate innovative solutions to problems and effectively collaborate with and communicate with key stakeholders.
• Active participation in departmental improvement activities such as system modifications, maintenance of standard operating procedures, internal guidelines, etc.
• Demonstrated flexibility in responding to changing priorities, multi-tasking and dealing with unexpected events.
• Effective leadership, communication, and interpersonal skills.
• Advanced knowledge of MS Office.
• Superior attentiveness to detail & has a strong regulatory background.
Qualifications we seek in you!
Bachelor’s or master’s degree required in science, engineering or related field (advanced degree preferred).
Why join Genpact?
• Lead AI-first transformation – Build and scale AI solutions that redefine industries
• Make an impact – Drive change for global enterprises and solve business challenges that matter
• Accelerate your career—Gain hands-on experience, world-class training, mentorship, and AI certifications to advance your skills
• Grow with the best – Learn from top engineers, data scientists, and AI experts in a dynamic, fast-moving workplace
• Committed to ethical AI – Work in an environment where governance, transparency, and security are at the core of everything we build
• Thrive in a values-driven culture – Our courage, curiosity, and incisiveness - built on a foundation of integrity and inclusion - allow your ideas to fuel progress
Come join the 140,000+ coders, tech shapers, and growth makers at Genpact and take your career in the only direction that matters: Up.
Let’s build tomorrow together.
RC - REGULATORY COMPLIANCE - REGULATORY COMPLIANCE - Senior
Posted today
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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
Legal Counsel - Compliance & Regulatory Affairs
Posted 11 days ago
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Job Description
Responsibilities:
- Develop, implement, and maintain comprehensive compliance programs and policies.
- Monitor changes in relevant laws and regulations and assess their impact on the company's operations.
- Conduct regular compliance audits and risk assessments to identify potential areas of non-compliance.
- Provide legal advice and training to employees on compliance-related matters.
- Investigate compliance violations and recommend corrective actions.
- Liaise with regulatory authorities and manage responses to inquiries and audits.
- Review marketing materials and business practices for regulatory compliance.
- Manage internal investigations and advise on disciplinary actions.
- Draft and update legal documents, including consent decrees and settlement agreements.
- Stay informed about industry trends and best practices in compliance and corporate governance.
Qualifications:
- Law degree (LL.B. or equivalent) from a recognized university.
- Admission to the Bar Council of India, with an active license to practice.
- Minimum of 5 years of experience in corporate law, with a strong focus on compliance and regulatory matters.
- In-depth knowledge of relevant Indian laws and regulations (e.g., Companies Act, SEBI regulations, data privacy laws).
- Experience in conducting internal investigations and managing regulatory interactions.
- Excellent analytical, problem-solving, and organizational skills.
- Strong written and verbal communication abilities.
- Ability to work effectively both independently and as part of a team.
- Proficiency in legal research and relevant compliance software.
- Detail-oriented with a high degree of accuracy.
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Regulatory Compliance Manager
Posted 1 day ago
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Manager – Regulatory Compliance
Those who share our core belief of 'Every Day is Game Day' We bring our best selves to work each day to realise our mission of enriching the world through the power of digital commerce and financial services.
ROLE PURPOSE
We are seeking a diligent and experienced regulatory compliance manager for our Prepaid Issuance business at Pine Labs. This mid to senior-level role is responsible for ensuring end-to-end regulatory compliance as defined in the Reserve Bank of India’s PPI Master Directions. The position demands strong audit capabilities, a deep understanding of the regulatory landscape, and the ability to work cross-functionally to maintain the highest standards of control, risk mitigation, and business continuity.
THE RESPONSIBILTIES, WE ENTRUST YOU WITH.
- Conduct periodic and thematic audits of Pine Labs’ PPI products and processes to ensure complete compliance with RBI’s PPI Master Directions and related regulatory guidelines
- Lead and execute detailed system/process audits with a focus on KYC controls, customer onboarding, transaction limits, system integrity, and operational checks as per PPI regulations
- Identify, assess, document, and communicate compliance and control issues with clear articulation of associated business risks to senior management
- Collaborate with Compliance, AML, Risk, Product, Business, and Technology teams to strengthen the control environment and embed a culture of compliance
- Present audit findings, recommendations, and risk assessments to leadership, facilitating awareness and alignment on corrective actions.
- Prepare comprehensive audit reports and dashboards for the Audit Committee and Management, providing actionable insights for decision-making.
WHAT MATTERS IN THIS ROLE
Experience & Portfolio
5–10 years of internal audit, risk, or compliance experience in regulated financial services (BFSI, fintech, payments, or NBFC sector preferred)
Proven expertise in system/process audits, particularly in KYC, limits, and transaction monitoring with a strong knowledge of RBI’s PPI Master Directions and other payments sector regulations in India.
Technical Skills & Efficiency
- Bachelor’s degree in accounting, Finance, Law, or related field; professional certifications (CISA, CIA, CA, etc.) are a plus
- Experience with automated control testing tools and data analytics for compliance assessments
- Adept at managing multiple priorities, closing audit findings promptly, and aligning work with strategic objectives
- Excellent presentation and communication skills to translate technical findings into actionable business insights for senior stakeholders.
- Strong project and stakeholder management skills with the ability to navigate cross-functional environments
THINGS YOU SHOULD BE COMFORTABLE WITH
Working from office : Bangalore
Pushing the boundaries
Have a big idea? See something that you feel we should do but haven’t done? We will hustle hard to make it happen.
Travel : Should be open to traveling within India for projects related to work for e.g. meetings, workshops etc.
WHAT WE VALUE IN OUR PEOPLE
You take the shot
You decide fast and deliver right.
You are the CEO of what you do
You show ownership and make things happen.
You sign your work like an artist
You seek to learn and take pride in the work you do.
Regulatory Compliance Manager
Posted today
Job Viewed
Job Description
Those who share our core belief of 'Every Day is Game Day' We bring our best selves to work each day to realise our mission of enriching the world through the power of digital commerce and financial services.
ROLE PURPOSE
We are seeking a diligent and experienced regulatory compliance manager for our Prepaid Issuance business at Pine Labs. This mid to senior-level role is responsible for ensuring end-to-end regulatory compliance as defined in the Reserve Bank of India’s PPI Master Directions. The position demands strong audit capabilities, a deep understanding of the regulatory landscape, and the ability to work cross-functionally to maintain the highest standards of control, risk mitigation, and business continuity.
THE RESPONSIBILTIES, WE ENTRUST YOU WITH.
Conduct periodic and thematic audits of Pine Labs’ PPI products and processes to ensure complete compliance with RBI’s PPI Master Directions and related regulatory guidelines
Lead and execute detailed system/process audits with a focus on KYC controls, customer onboarding, transaction limits, system integrity, and operational checks as per PPI regulations
Identify, assess, document, and communicate compliance and control issues with clear articulation of associated business risks to senior management
Collaborate with Compliance, AML, Risk, Product, Business, and Technology teams to strengthen the control environment and embed a culture of compliance
Present audit findings, recommendations, and risk assessments to leadership, facilitating awareness and alignment on corrective actions.
Prepare comprehensive audit reports and dashboards for the Audit Committee and Management, providing actionable insights for decision-making.
WHAT MATTERS IN THIS ROLE
Experience & Portfolio
5–10 years of internal audit, risk, or compliance experience in regulated financial services (BFSI, fintech, payments, or NBFC sector preferred)
Proven expertise in system/process audits, particularly in KYC, limits, and transaction monitoring with a strong knowledge of RBI’s PPI Master Directions and other payments sector regulations in India.
Technical Skills & Efficiency
Bachelor’s degree in accounting, Finance, Law, or related field; professional certifications (CISA, CIA, CA, etc.) are a plus
Experience with automated control testing tools and data analytics for compliance assessments
Adept at managing multiple priorities, closing audit findings promptly, and aligning work with strategic objectives
Excellent presentation and communication skills to translate technical findings into actionable business insights for senior stakeholders.
Strong project and stakeholder management skills with the ability to navigate cross-functional environments
THINGS YOU SHOULD BE COMFORTABLE WITH
Working from office : Bangalore
Pushing the boundaries
Have a big idea? See something that you feel we should do but haven’t done? We will hustle hard to make it happen.
Travel : Should be open to traveling within India for projects related to work for e.g. meetings, workshops etc.
WHAT WE VALUE IN OUR PEOPLE
You take the shot
You decide fast and deliver right.
You are the CEO of what you do
You show ownership and make things happen.
You sign your work like an artist
You seek to learn and take pride in the work you do.
Regulatory Compliance Specialist
Posted today
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About the Role:
We are seeking a Regulatory & Compliance Specialist on a contract basis to support our compliance requirements in India and international destination countries. This role is ideal for professionals experienced in handling regulatory filings, certifications, and export-related compliance in pharma, Ayurveda, nutraceuticals, or cosmetics.
Key Responsibilities:
- Apply for and renew licenses and certifications such as FSSAI, AYUSH, GMP, Organic, COSMOS as required.
- Arrange phytosanitary inspections and coordinate with laboratories and quarantine officers.
- Provide guidance on country-specific product classification (e.g., cosmetic vs. medicine).
- Maintain a compliance tracker for each product and destination country.
- Ensure smooth coordination with government departments, regulatory authorities, and testing labs.
Requirements:
- 3–6 years of experience in regulatory affairs, preferably in pharma, Ayurveda, or export compliance.
- Strong understanding of regulatory filings for African/CIS countries (preferred).
- Ability to work remotely and independently while managing communication with labs, certification bodies, and government departments.
- Excellent organizational and documentation skills.