248 Regulatory Compliance jobs in Mumbai

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:

Position Accountability/Scope:

Minimum Education:

B.Pharm / M.Pharm / M.Sc. or equivalent in pharmaceutical or life sciences discipline.

Minimum Experience/Training Required:

Regulatory Compliance Manager will be responsible for managing the continued development and implementation of a global trade compliance program.

Investigative skills will be applicable in managing trade compliance with other countries, as needed.

Acting as a regional trade compliance representative, you will maintain an active role in assuring compliance of import/ export activities in the company owned subsidiaries and offices in APJ. In respect of Customs regulations and import/export licence controls.

Apply continuity with the global trade compliance programs by country.

You will be responsible for identifying, prioritizing and addressing trade compliance risk and Customs compliance risk.

The initial focus of the Regulatory Compliance Manager is Export Control matters. This includes resolving potential DPL matches, transactional work with stakeholders, review of compliance holds on strategic or controlled goods-based end use/end user. The Regulatory Compliance Manager is responsible for collating and analyzing metrics related to export controls. The job will also involve supporting integration of systematic export controls into ERP systems. The role will develop and extend into areas of Customs (import/export) operational controls and will be responsible for process improvement and productivity improvements in that area.

• Be a subject matter expert and escalation person for matters related to trade compliance – export control, sanctions, Customs compliance.

• Be a facilitator to design and implement improved trade compliance programs working with vendors, brokers, and related internal and external business partners.

• Communicating and meeting with relevant Government authorities as needed.

• Complete timely and compliant transaction controls and reviews.

• Prepare and present relevant data analytics to support decision making

• Backup other APJ Trade Compliance activities, if required.

• The role will not line manage staff

• 5 to 8 Years of relevant international trade, import and export experience.

• University Degree or equivalent. Major in Legal, International Trade, Logistics or relevant preferred. Optional for candidates who has more relevant experience.

• Experience on Technology sector.

• Good technical and practical knowledge in customs and export control regulations in India, experience in Asia Pacific is a plus.

• Knowledge of US Export Administration Regulation and APJ Import and Export regulations.

• Operates without supervision within established guidelines.

• High level of independent thinking and problem-solving capabilities

• Able to identify and address potential risk at trade compliance

• Good IT skills (Microsoft office applications etc.).

• Able to provide interpretation of Regulations to internal and external business partners

• Able to converse and write effectively in English. Able to speak/ read in second language with Asia Pacific is an advantage but not mandatory.

• 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 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.

Your role

We are the members of a technology-focused team that works across the globe, delivering critical regulatory solutions and services to the Nasdaq markets. You will be responsible for crucial project delivery activities and internal business, legal and development team interactions. We will be responsible for prioritising potential issues across these groups and achieving consensus on a solution.

In this role, you will have an equal opportunity to work with strong experienced teams delivering critical technology solutions. You will work with and learn from domain experts, and have the opportunity to take on more responsibility within the Regulatory Technology team. Besides working closely with your colleagues in Mumbai, you will also work closely with Nasdaq teams in other countries.

We expect you to have:

Design, develop, fix and implement application software for Regulatory Technology projects.

Parse rulebooks language and design models that will be used as the basis for the design of test scripts.

Participate in business and technical design reviews of the trading engines, functional specification reviews, develop level of effort estimates for rulebook compliance testing.

Proactively identify and resolve potential problems/issues including input of rulebook language and functional behavior of trading engines.

Conduct testing, build models of the rules, review results, identify issues, and coordinate resolution between business, legal, and development groups.

Participate in surveillance pattern design reviews, build models and technical design documents, and conduct data analysis that will drive decisions on efficient parameter usage.

We expect you to have:

It would be great if you:

Does it sound like you? What happens now? 

As the selection process is ongoing, please submit your application in English as soon as possible. We will get back to you in 2-3 weeks.

Come as you are

Nasdaq is an equal opportunity employer. We positively encourage applications from suitably qualified and eligible candidates regardless of age, color, disability, national origin, ancestry, race, religion, gender, sexual orientation, gender identity and/or expression, veteran status, genetic information or any other status protected by applicable law.

Nasdaq is a leading global provider of trading, clearing, exchange technology, listing, information, and public company services. As the creator of the world's first electronic stock market, its technology powers more than 100 marketplaces in 50 countries. Nasdaq is home to over 4,000 total listings with a market value of approximately $12 trillion.

To learn more, about our business visit business.nasdaq.com. Check out more about our Life at Nasdaq.

Come as You Are

Nasdaq is an equal opportunity employer. We positively encourage applications from suitably qualified and eligible candidates regardless of age, color, disability, national origin, ancestry, race, religion, gender, sexual orientation, gender identity and/or expression, veteran status, genetic information, or any other status protected by applicable law.

We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request an accommodation.

Talent Worx is hiring!

Our client in India, a professional services firm, is the Indian member firm affiliated. Our professionals leverage the global network of firms, providing detailed knowledge of local laws, regulations, markets, and competition. Our client has offices across India in Ahmedabad, Bengaluru, Chandigarh, Chennai, Gurugram, Hyderabad, Jaipur, Kochi, Kolkata, Mumbai, Noida, Pune, and Vadodara. 

Our client in India offers services to national and international clients in India across sectors. We strive to provide rapid, performance-based, industry-focused, and technology-enabled services, which reflect a shared knowledge of global and local industries and our experience of the Indian business environment

Our client advisory professionals provide advice and assistance to enable companies, intermediaries, and public sector bodies to mitigate risk, improve performance, and create value. KPMG firms provide a wide range of risk advisory and financial advisory services that can help clients respond to immediate needs as well as put in place strategies for the longer term.

Projects in IT Advisory focus on the assessment and/or evaluation of IT systems and the mitigation of IT-related business risks. They are either system audits, IT reviews, technology risk assessments, or gap assessments in line with circulars issued by SEBI/RBI/IRDAI.

Requirements

• Strong experience in review of guideline defined, conducting regulatory assessments for BFSI (E.g. RBI, SEBI, IRDAI). Global guidelines knowledge which includes NIST, ISO27001, PCI-DSS, COBIT, etc. 
• Assisting in remediating gaps on the defined guidelines for the client.
• Performing System Audit and conducting technology landscape review.
• Having worked on Information Technology Risk Assessment areas such as – NIST, ISO27001, PCI-DSS, COBIT, etc.
• Experience of handling IT audits and reviews.
• Good understanding on technology topics related to cyber security, encryption, architecture resiliency , business continuity, disaster recovery, IT Governance, Third party outsourcing risk and information security/technology risk. 
• Certification - CISA, CISSP, ISO27001
• Good presentation and report writing skills is mandatory. 
• Excellent communication skills and confident demeanor 
• Experience of working with client stakeholders2
• Good problem-solving skills.
• Specially for Managers
• Experience of writing proposal and responding to RFP’s
• Handling team of 4-5 people
• Profiles from consulting background to be preferred.

Benefits

Work with one of the Big 4's in India

Healthy work Environment

Work Life Balance

Job Overview:

The Director of QRC, IN will serve as an active member of the Global Sales (GS) SAPAC region QRC leadership and IN SSU Leadership Teams, on top of the role as IN SSU Management Representative. He/ She will provide Regulatory & Quality Leadership for the IN SSU where Getinge is present. The incumbent is expected to have good understanding of the IN country’s QA & RA requirements and is also expected to lead activities to bridge gaps in the QMS & product registration requirements. Managing and insuring proper filing of all required compliance documents, submissions, registrations, etc to ensuring products supplied in India meet the requirements of the Medical Devices Rules 2017.

This role will have a solid line reporting to Senior QRC Director, APAC & dotted reporting to the Managing Director, IN SSU.

Job Responsibilities and Essential Duties:

• A list of the main responsibilities and percentage of time spent in each responsibility or group of responsibilities:
• (30%) Execute the job responsibilities according to applicable Global Sales Quality Management System (GS QMS), Local Quality Management System of India, and other requirements
• (30%) Ensure Post Market Vigilance activities are executed on a timely manner according with local and Getinge Corporate requirements
• (25%) People Leadership
• (15%) Product Registration on a timely & compliance manner

Strategic Planning

• Develop and implement local Quality Systems in line with Global Sales QMS
• Development and implementation of the QRC strategic plan.

Required Knowledge, Skills and Abilities

• Strong leadership and communication skills
• Resourceful and independent team player
• Mature, pro-active working attitude and able to work under pressure.
• A team player and a self-starter with strong inter-personal and presentation skills

Supervision/Management of Others

• Responsible for the development and management of QRC manager and specialist and programs for the team and retain high potential employee
• Provide clear direction and keep the work group moving forward and focused on the right

Internal and External Contacts/Relationships

• Main contacts, internal

o Management team

o QRC team in region

o BA QRC teams

o Sales department

o Service department

o Logistics department

• Main contacts, external

o Central Drugs Standard Control Organization, Ministry of Health & Family Welfare

• Other agencies such as Bureau of Indian Standards

o ISO certification body (TUV SUD Europe)

o Distributors

Environmental/Safety/Physical Work Conditions

• Ensures environmental consciousness and safe practices are exhibited in decisions.
• Use of computer/ laptop and telephone equipment and other related office accessories/devices to complete assignments
• May work extended hours during peak business cycles & desk bound e.g. ISO certification audit & preparation of product registration documents for submission.
• Physical requirements: requires carrying of laptop and its associated accessories during travelling.
• Travel requirements: requires occasional interstate travel and international travel

Minimum Requirements:

• Bachelor’s degree in engineering or Life Science related field or equivalent.
• A minimum of 10 years hands-on experience in Quality Assurance, preferably in a medical device company.
• Able to work ground up to build the quality system in the R&D organization to match and surpass global requirements and customer expectations.
• Startup mindset, where person should be able to work on the ground at the initial phase while working on the future development of the quality organization. Experience similar to this will be an added advantage.
• Progressive leadership experience including hands on advanced quality system strategy.
• Excellent knowledge of FDA and EU regulatory compliance for medical devices.
• Demonstrated knowledge of Quality System Regulation (QSR) and Quality System Inspection Technique Audits (QSIT).
• Strong influencing skills and the ability to build strong interpersonal relationships.
• Excellent communication skills including public speaking and strong written skills.
• Demonstrated leadership in a cross-functional environment.
• Advanced skills in MS Office applications (Word/Excel) are required.

Job Overview:

The Director of QRC, IN will serve as an active member of the Global Sales (GS) SAPAC region QRC leadership and IN SSU Leadership Teams, on top of the role as IN SSU Management Representative. He/ She will provide Regulatory & Quality Leadership for the IN SSU where Getinge is present. The incumbent is expected to have good understanding of the IN country’s QA & RA requirements and is also expected to lead activities to bridge gaps in the QMS & product registration requirements. Managing and insuring proper filing of all required compliance documents, submissions, registrations, etc to ensuring products supplied in India meet the requirements of the Medical Devices Rules 2017.

This role will have a solid line reporting to Senior QRC Director, APAC & dotted reporting to the Managing Director, IN SSU.

Job Responsibilities and Essential Duties:

• A list of the main responsibilities and percentage of time spent in each responsibility or group of responsibilities:
• (30%) Execute the job responsibilities according to applicable Global Sales Quality Management System (GS QMS), Local Quality Management System of India, and other requirements
• (30%) Ensure Post Market Vigilance activities are executed on a timely manner according with local and Getinge Corporate requirements
• (25%) People Leadership
• (15%) Product Registration on a timely & compliance manner

Strategic Planning

• Develop and implement local Quality Systems in line with Global Sales QMS
• Development and implementation of the QRC strategic plan.

Required Knowledge, Skills and Abilities

• Strong leadership and communication skills
• Resourceful and independent team player
• Mature, pro-active working attitude and able to work under pressure.
• A team player and a self-starter with strong inter-personal and presentation skills

Supervision/Management of Others

• Responsible for the development and management of QRC manager and specialist and programs for the team and retain high potential employee
• Provide clear direction and keep the work group moving forward and focused on the right

Internal and External Contacts/Relationships

• Main contacts, internal

o Management team

o QRC team in region

o BA QRC teams

o Sales department

o Service department

o Logistics department

• Main contacts, external

o Central Drugs Standard Control Organization, Ministry of Health & Family Welfare

• Other agencies such as Bureau of Indian Standards

o ISO certification body (TUV SUD Europe)

o Distributors

Environmental/Safety/Physical Work Conditions

• Ensures environmental consciousness and safe practices are exhibited in decisions.
• Use of computer/ laptop and telephone equipment and other related office accessories/devices to complete assignments
• May work extended hours during peak business cycles & desk bound e.g. ISO certification audit & preparation of product registration documents for submission.
• Physical requirements: requires carrying of laptop and its associated accessories during travelling.
• Travel requirements: requires occasional interstate travel and international travel

Minimum Requirements:

• Bachelor’s degree in engineering or Life Science related field or equivalent.
• A minimum of 10 years hands-on experience in Quality Assurance, preferably in a medical device company.
• Able to work ground up to build the quality system in the R&D organization to match and surpass global requirements and customer expectations.
• Startup mindset, where person should be able to work on the ground at the initial phase while working on the future development of the quality organization. Experience similar to this will be an added advantage.
• Progressive leadership experience including hands on advanced quality system strategy.
• Excellent knowledge of FDA and EU regulatory compliance for medical devices.
• Demonstrated knowledge of Quality System Regulation (QSR) and Quality System Inspection Technique Audits (QSIT).
• Strong influencing skills and the ability to build strong interpersonal relationships.
• Excellent communication skills including public speaking and strong written skills.
• Demonstrated leadership in a cross-functional environment.
• Advanced skills in MS Office applications (Word/Excel) are required.