POSITION OVERVIEW
The
Director, Legal & Compliance – India
shall have the primary responsibility to provide legal and compliance advice and protect the legal interests and compliance standards of all businesses (e.g. Global Human Health and Animal Health), divisions and functions in India, supporting the Regional Managing Counsel, Asia Pacific. The position will be based in Mumbai, India.The successful candidate will lead a team of two members and handle legal and compliance matters arising from businesses in India or as designated by and under the supervision of the Regional Managing Counsel, Asia Pacific. As a member of the Asia Pacific Legal and Compliance team, the successful candidate will work closely with the Country Leadership Team, the India Human Health Business Practice Officers (“
BPOs
”), as well as other members of the Asia Pacific Legal and Compliance team, colleagues from the Offices of General Counsel, external counsel and relevant headquarters and subsidiary staff and functional groups, as needed.
Primary Scope Of Work
Primary scope of work includes, but is not limited to the following
- Supporting the legal and compliance needs of all key stakeholders in the relevant areas of law which may include but is not limited to privacy, anti-corruption/anti-bribery, fair competition, and trade practice legislations. Separately, the successful candidate shall also have a good grasp of policies, compliance standards and local industry guidelines. In particular, he/she shall
- Commercial and Contractual Matters
- Advise on day-to-day commercial transactions and business undertakings
- Advise on business development, marketing and business initiatives, patient and disease awareness programs, review and draft/negotiate related agreements
- Advise on commercial/corporate and employment issues and negotiate with external parties on behalf of , where needed or appropriate
- Advise on innovative solutions with a particular interest in patient programs, digital, technology and data-analytics
- Regulatory Requirements
- Monitor changes and developments in the legal and regulatory environment within which businesses operate, advise local management and develop appropriate strategies
- Provide advice and legal support, as needed and in collaboration with regulatory affairs, on application and maintenance of all authorizations, permits and licenses needed for local operations, including importation, listing/reimbursement and marketing of products, conducting clinical trials, handling adverse experience incidents and implementing product recalls where needed
- Support in interactions with regulatory and other relevant government agencies on legal and compliance issues and development of appropriate strategies for resolution of issues
- Promotional Review
- Provide and/or oversee internal legal review as part of medical-legal process for promotional materials according to local laws and policies and standards
- Collaborate with Medical and business colleagues in initiating and/or responding to regulatory/competitor challenges on promotional practices
- Business Standards & Compliance
- Develop, monitor and implement compliance and risk management strategies and processes, and work with divisional compliance and local BPOs and management.
- Where appropriate, conduct legal & compliance training; monitor and resolve legal & compliance issues, work with local management to formulate and implement appropriate local business standards and procedures consistent with local laws, US laws (including the US Foreign Corrupt Practices Act (FCPA)), industry standards (including local pharmaceutical industry Codes of Conduct and the International Federation of Pharmaceutical Manufacturers Association (IFPMA) Code of Marketing Practices) and corporate policies.
- Disputes/Litigation
- Support the initiation, defence, negotiation, settlement and management of litigation, disputes and actions arising from business operations of including contractual, IP, adverse reaction claims, compliance and regulatory challenges, in collaboration/consultation with regional legal team and other legal colleagues from headquarters or other divisions as appropriate
- Intellectual Property
- Support headquarters IP attorneys to coordinate with local external counsel as needed on local trademark and patent filings and collect and disseminate intellectual property information for local management
- Provide advice on local strategies and counteractions in relation to local IP infringement and enforcement actions, in collaboration with global IP attorneys
- Human Resources
- Advise on sensitive HR/Labor law-related issues arising
- Participate in internal investigations remediation team and provide legal and compliance perspective, as appropriate
- Others
- Conduct internal investigations, where necessary, in collaboration with Global Investigations Human Resources and Global Security Group, and coordinate with Corporate Audit, local management and Finance/HR groups in taking practical and appropriate remediation actions as needed
- Additional responsibilities and projects may be assigned by the Regional Managing Counsel, Asia Pacific on an ad-hoc basis
- Participate, as part of the Country Leadership Team in meetings of the Country Compliance Committee, Local Review Boards, Grants Committee and other compliance or country-level committees in India
- Collaborating and instructing external counsel where needed and to provide inputs and oversight of the work done by external counsels
- Guiding, motivating, and directing the India legal and compliance team toward achieving the international legal and compliance function’s goals. This includes setting a clear vision, communicating effectively, delegating tasks, fostering collaboration, and providing support for team member development
- Supervising and managing the legal budget for India in accordance with approved guidance from regional/global Legal and Compliance management
WHAT WILL A SUCCESSFUL APPLICANT LOOK LIKE?
Qualifications
- A degree in law or the equivalent
- Admitted to practice law in India
- 10 or more years of post-admission experience
Skillsets
- Strong language proficiency in English required
- Ability to manage India largely independent of management supervision
- Ability to quickly distil and effectively communicate corporate (HQ) cascaded compliance positions and policies to the local market.
- Ability to identify and balance legal/compliance risks with business opportunities and provide counsel to local market leadership on such risks
- Ability to communicate confidently and effectively across the India organization
- Ability to guide, motivate, and inspire team members towards a common goal
- Ability to appropriately challenge the status quo whilst understanding the fundamental legal & compliance principles and our company’s standards at the enterprise level
- Ability to provide practical and commercially focused solutions whilst consistently applying a high standard of integrity, professionalism, legal knowledge, and business ethics in line with the company’s policies, values and standards
- Ability to understand and balance local market needs with enterprise level principles and direction
- Analyzing situations, weighing options, and making sound judgment and choices under pressure
- Proactive and responsive
- Strong communication and interpersonal skills
Knowledge & Experience
The following experience is required- In-house legal and compliance experience in a multinational organization; and/or
- In-house legal and compliance experience in a pharmaceutical company or other highly regulated industries (e.g. biochemicals, medical devices industry); and/or
- Commercial practice experience in a top tier law firm
The Following Experience Is Highly Preferred
- Familiarity with the US FCPA, the IPMG Code of Conduct, the IFPMA Code of Marketing Practices and local pharmaceutical related laws, regulations, anti-bribery laws and codes of conduct in the India would be advantageous
- Ability to proficiently advise on and apply the following to local business operations/practices
- The Drugs Act and Cosmetics Act, 1940
- The Drugs and Cosmetics Rules, 1945
- Applicable Labor Laws and Industrial Relations
Current Employees apply HERECurrent Contingent Workers apply HERE
Search Firm Representatives Please Read Carefully
Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.
Employee Status
Regular
Relocation
VISA Sponsorship
Travel Requirements
Flexible Work Arrangements
Hybrid
Shift
Valid Driving License
Hazardous Material(s)
Required Skills
Business Development, Business Initiatives, Cite Checking, Clinical Testing, Commerical Transactions, Confidentiality, Customer Service Leadership, Data Security Management, Ethics, Exercises Judgment, Legal Research, Legal Strategies, Marketing Initiatives, Multilingualism, Negotiation, Pharmaceutical Law, Pharmacy Regulation, Product Risk Management, Products Liability Litigation, Regulatory Affairs Compliance, Regulatory Compliance, Risk Management, Site Initiation, Trial Preparation
Preferred Skills
Job Posting End Date
08/20/2025
- A job posting is effective until 11 59 59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.
Requisition ID
R358564
