1,152 Pharmaceutical Compliance jobs in India
Senior Regulatory Affairs Specialist, Pharmaceutical Compliance
Posted 13 days ago
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Job Description
Responsibilities:
- Prepare, review, and submit regulatory dossiers for new drug applications (NDAs), variations, and renewals to health authorities worldwide (e.g., FDA, EMA, CDSCO).
- Interpret and apply complex national and international pharmaceutical regulations, guidelines, and standards.
- Develop and implement regulatory strategies to support product approvals and maintain market compliance.
- Liaise directly with regulatory agencies, responding to queries and managing communications throughout the submission and review process.
- Assess the regulatory impact of product changes, manufacturing processes, and marketing materials.
- Provide regulatory guidance and training to internal teams, including R&D, quality assurance, and marketing.
- Monitor regulatory intelligence and landscape changes, assessing their impact on the company's product portfolio.
- Contribute to the development and improvement of regulatory affairs processes and SOPs.
- Manage post-approval regulatory activities, including annual reports and safety updates.
- Collaborate with cross-functional teams to ensure regulatory requirements are met at all stages of the product lifecycle.
- Review and approve labeling and promotional materials to ensure compliance with regulations.
- Maintain up-to-date knowledge of therapeutic areas and competitive regulatory environments.
- Bachelor's or Master's degree in Pharmacy, Life Sciences, Chemistry, or a related field.
- Minimum of 7 years of progressive experience in pharmaceutical regulatory affairs.
- Demonstrated success in preparing and submitting regulatory dossiers to major health authorities.
- In-depth knowledge of pharmaceutical regulatory requirements in key markets (e.g., US, Europe, India).
- Experience with eCTD (electronic Common Technical Document) formatting and submission is essential.
- Strong understanding of GMP, GLP, and GCP principles.
- Excellent analytical, problem-solving, and critical thinking skills.
- Superior written and verbal communication skills, with the ability to negotiate effectively.
- Detail-oriented with exceptional organizational and project management abilities.
- Ability to work independently, manage multiple projects, and meet demanding deadlines in a remote setting.
- Experience with biologics or complex generics is a significant advantage.
Senior Regulatory Affairs Specialist - Pharmaceutical Compliance
Posted 21 days ago
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The Senior Regulatory Affairs Specialist will be responsible for preparing, submitting, and maintaining regulatory documentation for drug product registrations and approvals. You will liaise with health authorities (e.g., CDSCO, US FDA, EMA), manage post-approval changes, and ensure adherence to all relevant guidelines and regulations. Key responsibilities include developing regulatory strategies, assessing the regulatory implications of product development and lifecycle management, and contributing to the preparation of dossiers (e.g., CTD format). You will also monitor changes in the regulatory landscape and advise the organization accordingly. A strong understanding of pharmaceutical manufacturing processes and quality systems is crucial.
The ideal candidate will possess a Bachelor's or Master's degree in Pharmacy, Chemistry, or a related life science field, with a minimum of 6 years of experience in pharmaceutical regulatory affairs. Proven experience in preparing and submitting regulatory dossiers for various markets is essential. A thorough understanding of GMP, GCP, and GLP guidelines, along with extensive knowledge of Indian regulatory requirements and familiarity with major international regulations, is required. Excellent communication, analytical, and project management skills are paramount. This is an excellent opportunity for a dedicated regulatory professional to contribute to bringing essential medicines to market by ensuring rigorous compliance.
Key Responsibilities:
- Prepare, review, and submit regulatory dossiers for new drug applications and variations.
- Liaise with regulatory health authorities for submissions and inquiries.
- Ensure compliance with national and international pharmaceutical regulations (e.g., CDSCO, FDA, EMA).
- Manage post-approval changes and lifecycle management activities.
- Develop regulatory strategies for product development and market entry.
- Assess regulatory risks and opportunities associated with product portfolios.
- Provide regulatory guidance to R&D, manufacturing, and quality assurance teams.
- Monitor and interpret regulatory guidelines and advise on their impact.
- Maintain regulatory databases and ensure accurate record-keeping.
- Minimum of 6 years of experience in pharmaceutical regulatory affairs.
- Proven experience in preparing and submitting regulatory dossiers (e.g., CTD).
- In-depth knowledge of Indian and international pharmaceutical regulatory requirements.
- Familiarity with GMP, GCP, and GLP guidelines.
- Excellent written and verbal communication skills.
- Strong analytical and problem-solving abilities.
- Bachelor's or Master's degree in Pharmacy, Chemistry, or a related life science field.
- Ability to work effectively in a dedicated office environment.
Senior Consultant - Pharmaceutical Industry
Posted 5 days ago
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Please apply only after carefully reading the JD and confirming your fit.
Are you looking for a role that blends complex problem-solving , deep research , and strategic impact with unparalleled learning opportunities ?
At Axience , our Research & Consulting vertical partners with leading Fortune 5000 corporates and high-growth start-ups to help them grow, optimize, and innovate — all backed by exceptional research, analytics, and strategic insights delivered by an exceptionally driven, hard working, best-in-class teams.
We request you to not apply to the role without carefully reading the job description and establishing your suitability.
About Axience
- Axience is a professional business services firm, established with a credo of delivering “Integrated Bespoke Solutions” for our clients. Our vision is to "Impact our clients, colleagues and community with innovation, insight and empathy
- We provide high quality bespoke and boutique-style financial and business research services and have established ourselves as a well-regarded research firm with a strong clientele, board and management team
- Our main offices are located in Mumbai (India) with extended sales and execution capabilities in UAE, Canada and we plan to ramp up our teams in these places and farther
- We seek to hire and develop talent which is our industries' best in quality, efficiency, ambition and enthusiasm and love a fast paced, hard working environment
Consultant / Senior Consultant: Pharmaceutical and Non-Phaarma Corporates - Insights, Intelligence and Advisory Role
· Support pharmaceutical manufacturers, devices and diagnostics, hospital and healthcare, payors, digital health, healthcare consulting and intelligence firms and other clients
- Work on primary research, secondary research and other Axience comprehensive insight, intelligence and advisory related research processes
- Support strategy and corporate development, commercial/brand and competitive/markets intelligence/insight functions of highly reputable and demanding clients
- Produce competitive deep-dives and profiles, highly analytical news letters, event analysis and dashboards for key therapy areas and devices/diagnostics product and services
· Understand research objectives, design partial or full research strategies, interpret and analyse and present information for accuracy, exhaustiveness, and applicability
Take responsibility of end-to-end execution of projects with low levels of supervision required (although experienced team managers are always available for guidance)
- The role also provides an opportunity to work on non pharma projects time to time and devop both business and financial analysis skills providing an opportunity for well rounded skill development
- Support inside sales, presales and business development operations related to industry/TA part of the role and beyond
Senior Consultants and other advanced levels are expected to manage multiple team members while being individual contributors and engagements and contribute significantly to firm building activities and typically have 4+ years of progressive, top quality experience with demonstrable skill sets
Consultants have zero to three years experience supported by strong education, internships and exposures
Research and Consulting Vertical / Pharma Sub-Vertical
· Our Research and Consulting vertical supports Corporates and Professional Services providers and helps them grow and optimize with conviction, powered by exceptional research and insights services.
· We work directly with CXO offices, Chiefs of Staff, Corporate Development & Strategy, and Commercial / Sales / Marketing leaders
· We offer our services through mix of ongoing analyst support and custom, high-impact engagements and tends to be more complex and engaging then most of our peers.
o This combination means our work is more engaging, strategic, and rewarding than most peers in the industry.
· Within our Research and Consulting vertical, we have developed specialization and expertise in pharmaceutical industry cluster and our clients include top pharma manufacturers and diagnostics / devices companies
Qualifications & Experience
Mandatory Requirements:
- Minimum 4 years in strategy consulting, competitive intelligence, or market intelligence at top consulting/research firms OR
- PhD in Life Sciences from top international universities with strong research credentials OR
- 1–2 years of international experience in pharmaceutical strategy, competitive intelligence, or market analysis
Educational Background:
- Top-tier academic performance is essential.
- Fresh Masters/MBA graduates from Tier 1/equivalent Indian institutes or
- Top Life Sciences focused education from global top schools
Skills & Attributes
- Highly entrepreneurial, inquisitive, and analytical mindset
- Ability to thrive in a non-bureaucratic, fast-paced environment
- Exceptional problem-solving, communication, and stakeholder management skills
- Exposure to pharma/life sciences strategy, market intelligence, or competitive analysis required for senior consultant and preferred for consultants
What We Offer
- Opportunity to work with exceptionally qualified professional internally and externally
- Fast-track learning and growth in a meritocratic and hard-work focused environment
- Exposure to global clients, international markets, and strategic challenges
- A collaborative and entrepreneurial work culture
Contact
If you have the qualification, experience, and passion for the role mentioned above then please apply with a detailed custom cover letter on linkedin (LINK) or at While sending application please clearly mention the subject as: “Name: Location: Job-title” for example: “Donald Modi: Kolkata: Consultant - Pharma” where Location is your current location.
Head of Pharmaceutical Quality Assurance and Compliance
Posted 6 days ago
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COMPLIANCE OFFICER
Posted 2 days ago
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Job Description
**This role can be based in Brazil (Rio de Janeiro), Philippines (Manila), Shanghai (China) or Gurgaon (India) offices.**
Main Tasks:
- Maintains/executes and improves the compliance program in all procurement relevant aspects, eg.
Applicable policies and procedures (e.g. third party due diligence)
Monitoring of business transactions and corporate activities, processes, structures, relations as well as external developments
Training framework and content adaptation
Communicative instruments: e.g. intranet, e-mail / newsletters, MS Teams, etc.
Control framework and relevant first and second level controls
Regular and ad hoc reporting framework
- Ensures regular and ad hoc information flow to all relevant stakeholders for a sound collaboration in between all affected compliance and procurement departments
- Conduct regularly reporting to internal and external stakeholders
- Ensures monitoring of regulatory developments and adaption of Compliance Program accordingly, e.g. attending events, associations and doing research
- Oversees and takes part in relevant projects as needed
- Identifies, organizes and participates proactively in relevant compliance and investigation training, networks and other respective educational activities for further professional development in consultation with the Head of Global Procurement Compliance
Additional Tasks:
Tasks performed regularly in addition to the main duties, but which do not determine the essential character of the position.
_-_ Situational assignment of additional tasks/projects in the field of compliance in consultation with the director of global procurement compliance
- Substitute to the head of global procurement compliance, if needed
Required Training and Education:
+ University degree or equivalent qualification in Business, Economics, Law or similar specialization
+ Additional certifications may be beneficial
Required Professional Experience:
+ Minimum 6 years of general professional experience, with a minimum of 4 years in operational positions in the field of compliance / risk management, regulatory and/or procurement, preferably in the healthcare industry, is beneficial
+ International experience as well as change and project management experience is beneficial
Important Personal Qualities:
+ Good intercultural and interpersonal skills, proficient communication and sound presentation/moderation skills
+ Strong result driven attitude with problem solving capabilities
+ Good analytical skills, pragmatic creativity, a balanced judgment and sound ability to make qualitative decisions
+ High degree of integrity, confidentiality, trust and accountability
+ Ability to integrate into a team environment with an experienced collaboration practice
+ Fast apprehension and familiarization with new and complex tasks
+ Adequate self and time management
+ Good negotiation and mediation skills as well as confidence to handle difficult conversations, pressures and deadlines and ability to deal effectively with all organizational levels
+ Organizational savvy on processes and politics
+ Solid degree of flexibility, e.g. willingness to travel or situational adaptation to differing time zones
Other specialized knowledge:
a) Technical knowledge
- Compliance, legal and procurement acumen
b) Languages
- Fluency in English
- German or other languages may be beneficial
c) IT skills
- Solid command of MS-office tools, OnBoard (JIRA) and general ability to adapt new technologies
Compliance Officer
Posted today
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Reports to: Head of Compliance
Key Responsibilities:
1. Ability to liaise and interact with regulators.
2. Ability to manage Audits.
3. Ensuring 100% compliance across all existing and new products that the company manages.
4. Ensuring end-to-end compliance with the provisions of all regulatory requirements i.e SEBI, IFSCA, Companies Act, FEMA etc.
5. Should be aware of the latest regulatory requirements on all products.
6. Support and guide in the implementation of new products as required by the company.
7. Ensure all regulatory changes/ updates as given by the regulators are managed and installed in the system.
8. Drafting and vetting of legal agreements/ contracts/ MOU/ notices to support the business and products team.
9. Work on any other compliance matters as assigned from time to time.
10. Ability to communicate well at all levels and directly engage with the Board of Directors and Managing Director on all compliance related aspects.
Role Requirements:
• Graduation/ CA / MBA
• Company Secretary is good to have but not mandatory.
• Minimum 4 + years of relevant experience
• Experience in PMS compliance / AIF Compliance / Gift AIF and Distribution compliance will be preferred
Compliance Officer
Posted 4 days ago
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Job Title: Manager - AIF Cat III & Fund Management Entity (FME) / Compliance Officer
Location: GIFT City, Gujarat
Reporting to: Group CFO
Key Responsibilities:
2. Compliance & Regulatory Reporting
- Ensure ongoing compliance with SEBI AIF Regulations, IFSCA (Fund Management) Regulations, Companies Act, FEMA, and other applicable GIFT City guidelines.
- File periodic reports, including monthly, quarterly, and annual filings with IFSCA
- Assist in drafting and maintaining compliance manuals, SOPs, and internal policies.
- Ensure timely submission of regulatory forms, including AIF returns, KYC, and AML reporting.
- Coordinate with auditors, legal advisors, tax consultants, and regulators.
4. Others
- Manage documentation including board minutes, investor communications, and vendors & service provider agreements.
- Support in organizing board and investor meetings, keeping minutes, and ensuring necessary resolutions are passed and filed.
- Maintain physical and digital filing systems for statutory and operational documents.
Candidate Profile: CA / CFA / CS / MBA Finance with 5 years+ experience (relevant experience is preferred)
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Compliance Officer
Posted 5 days ago
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We are hiring for leading NBFC client based in Kochi.
Key Responsibilities
- Design, execute, and oversee the company’s AML & CTF compliance program
- Perform ongoing risk assessments for money laundering and financial crime
- Monitor customer transactions and flag unusual or suspicious activity
- Review and escalate Suspicious Activity Reports (SARs) to MLRO or reporting officer
- Enforce KYC / CDD compliance standards
- Conduct compliance audits and periodic reviews
- Stay updated on regulatory changes (e.g. FATF, FCA, FinCEN, RBI or local AML guidelines)
- Maintain accurate records & documentation per regulatory requirements
Qualifications & Skills
- Bachelor’s in Finance, Law, Business, or related discipline
- 3–5 years’ experience in AML / compliance (financial services or fintech)
- Strong knowledge of AML / CTF laws and regulatory frameworks
- Hands‑on experience with KYC, transaction monitoring, sanctions screening
- AML / Compliance certification preferred
- Proficiency in AML / compliance software tools
Compliance Officer
Posted 5 days ago
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Job Description
Prudent Corporate Advisory Services Ltd is urgently hiring for the post of Compliance Officer .
Location : Ahmedabad
Experience required : Min 2 Years
Job Description:
Compliance with various regulations governing Mutual funds, Bonds, Insurance, NPS and other financial products;
Liaise with external legal and regulatory authorities,
Drafting & vetting of agreements
submission of various compliance reports with regulators
Interested candidates can share their updated resume on
Compliance Officer
Posted 5 days ago
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Job Description
- Ensure compliances with respect to SEBI Guidelines.
- Monitoring changes in relevant legislation and the regulatory environment and taking appropriate action.
- Carrying out periodic reviews to ensure legal compliances of trading membership (like exchange compliances, SEBI compliances, Companies Act)
- Assisting the team in organizing, preparing agenda for and recording minutes of board meetings and general meetings.