97 Policy Implementation jobs in India
Regulatory Compliance
Posted 6 days ago
Job Viewed
Job Description
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:**
**Regulatory Submissions and compliance**
+ Prepare and submit various applications such as additional product permission, Layout approval, facility modification approval, technical person approval, Test license, amendments in licenses, State GMP and GLP certificate applications, post approval changes etc. to State FDA
+ Prepare and submit applications such as Test license NOC, WHO GMP applications, CPP applications for additional products.
+ Ensure timely submissions and approvals for all regulatory filings.
+ Evaluate technical and scientific data for regulatory submissions.
+ Liaise with health authorities for inspections, clarifications, and approvals.
+ Ensure compliance with D&C Act, NDPS Act, Gazette Notifications, and internal SOPs.
**Product & Business Support**
+ Handle product complaints from regulatory authorities, coordinating with QA, Legal, SCM, and Manufacturing for resolution.
+ Provide regulatory support for internalization and externalization of products.
+ To provide site CMC documents to international business team to support export registration.
**Documentation & Quality Oversight**
+ Maintain and update regulatory databases, trackers, licenses, and approvals.
+ Review and track regulatory impact of quality documents such as change controls, deviations, FLQRs, and product certifications.
+ Evaluate and approve site change controls and Change Request evaluation forms.
+ Provide working standards/specifications and CoAs to regulatory authorities and internal teams.
**Tender Certificates**
+ To obtain NCC, Manufacturing & Marketing Certificates, and CMC documents to support institutional and international business.
+ Coordinate with Institutional business team and site team for documentation as well as to facilitate site inspection of tendering authority.
**Governance, SOPs & Training**
+ Support the preparation, revision, and implementation of Regulatory SOPs and work instructions.
+ Deliver training on GMP, regulatory updates, and SOPs at the site level.
+ Approve SCNs from Corporate QA and review reports from regulatory authorities.
**Additional Responsibilities**
+ Complete assigned trainings on time
+ Perform other duties as assigned by the Regulatory Affairs leadership.
+ Act as the regulatory lead for the site, ensuring alignment with corporate and regulatory expectations.
**Position Accountability/Scope:**
+ ·Responsible for all regulatory activities for the manufacturing site mainly LL sites.
+ ·Ensures site compliance with applicable national regulations and Abbott standards.
+ Supports business continuity through proactive regulatory planning and execution.
**Minimum Education:**
B.Pharm / M.Pharm / M.Sc. or equivalent in pharmaceutical or life sciences discipline.
**Minimum Experience/Training Required:**
+ **Manager:** Minimum 08 - 12 years of experience in Regulatory Affairs preferably with a multinational or leading Indian pharmaceutical company. Prior experience in Quality Assurance is desirable.
+ Familiarity with regulatory platforms (SUGAM, ONDLS, NSWS, SolTRAQs) is desirable.
An Equal Opportunity Employer
Abbot welcomes and encourages diversity in our workforce.
We provide reasonable accommodation to qualified individuals with disabilities.
To request accommodation, please call or email
Regulatory Compliance
Posted today
Job Viewed
Job Description
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:
Regulatory Submissions and compliancePosition Accountability/Scope:
Minimum Education:
B.Pharm / M.Pharm / M.Sc. or equivalent in pharmaceutical or life sciences discipline.
Minimum Experience/Training Required:
RC - REGULATORY COMPLIANCE - REGULATORY COMPLIANCE - Senior
Posted today
Job Viewed
Job Description
The opportunity
We’re looking for Senior with expertise in LIMS Implementations & Configurations for Life Sciences industries 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
Regulatory Compliance Specialist
Posted today
Job Viewed
Job Description
The Regulatory Compliance Specialist is a key position in the Regulatory Compliance organization. This position drives the daily compliance activities required under the company's trade compliance policy. The Regulatory Compliance Specialist is primarily responsible for resolving potential DPL matches and work with stakeholders that these are not exact matches. This position also reviews compliance holds relative to strategic or controlled goods and based on the nature of end-customers, determines whether a license or government authorization is required to make the sale or the export. This position is involved in conducting risk assessment of end-customers and categorize them accordingly based on a defined criterion. The Regulatory Compliance Specialist is responsible for analyzing metrics that track turnaround times in reviewing and releasing DPC and ECCN holds. Minimum supervision is required for this role.
Responsibilities:Address DPC escalations relating to potential matches when screening new customers, vendors or subcons.
Assist in determining the in-country HS codes for articles created in SAP system.
Perform ECCN review and determine license/regulatory requirements for all sales transactions.
Extract report from SAP system for DPC and ECCN Hold Metrics per month. Analyze metrics & determine actions further improve turnaround time or reduce DPC holds.
Prepare other trade compliance reports as required by the department.
Perform risk assessments on end-customers and categorize them according to a pre-determined criterion.
Perform ECCN validation of new articles created in SAP.
Knowledge, Skills and Experience:
3 to 5 Years of relevant work experience.
Associate degree with International Trade or Logistics field of study required.
Minimum Diploma in International Trade or Logistics or Supply Chain
Able to execute instructions and to request clarification when needed.
Able to use a 10-key quickly and accurately.
Possesses basic clerical and data entry skills.
Possesses strong data entry skills.
Able to recognize and attend to important details with accuracy and efficiency.
Able to communicate clearly and convey necessary information.
Able to converse and write effectively in English.
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 work independently with minimum supervision.
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.
Manager, Regulatory & Compliance
Posted today
Job Viewed
Job Description
Job Description
Opportunity : Our Advisory Services team provides custom advisory services to clients including hedge funds, private equity, fund of funds, real estate, venture capital, family offices, wealth management firms, and broker/dealers. We utilize our deep expertise in finance, accounting, compliance, fund administration, operations, and due diligence to support various aspects of our client’s non-investment business function. Our team successfully ensures that projects are executed efficiently and in accordance with industry leading practices and regulatory requirements.
Within this role you will have the opportunity to participate in various projects including, but not limited to Operational Due Diligence Assessments, Loan Transaction Review, Due Diligence Questionnaire and Policy Creation Support Services, Project Management, Strategic Development, Launch and Winddown Advisory, and Corporate Secretarial Services. This breadth of work allows individuals on our team to find their niche and apply themselves in those areas.
A strong Operational Due Diligence background lends itself to several other projects for which our group is engaged.
Role-Specific Accountabilities:
Regulatory Compliance Manager
Posted today
Job Viewed
Job Description
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.
Job DescriptionThe 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.
Responsibilities: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.
Executive - Regulatory Compliance
Posted today
Job Viewed
Job Description
KPMG entities in India are professional services firm(s). These Indian member firms are affiliated with KPMG International Limited. KPMG was established in India in August 1993. Our professionals leverage the global network of firms, and are conversant with local laws, regulations, markets and competition. KPMG has offices across India in Ahmedabad, Bengaluru, Chandigarh, Chennai, Gurugram, Jaipur, Hyderabad, Jaipur, Kochi, Kolkata, Mumbai, Noida, Pune, Vadodara and Vijayawada.
KPMG entities in India offer 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.
Role
Axiom - Reg Reporting
Grade
B2 - C1
Technology, Roles & Responsibilities
Axiom solutions, Financial reportings
Years of Experience
2 - 6 years
- Design, develop, and implement Axiom solutions to automate financial reporting processes and ensure regulatory compliance.
- Collaborate with finance and regulatory teams to understand requirements and translate them into technical solutions within the Axiom platform.
- Configure and customize Axiom modules to meet specific business needs, including data mapping, validation rules, and report generation.
- Perform data analysis and reconciliation to ensure accuracy and integrity of financial data within the Axiom platform.
- Troubleshoot and resolve issues related to Axiom functionality, data integration, and reporting discrepancies.
- Develop and maintain documentation, including technical specifications, user guides, and process documentation.
- Provide training and support to end users to maximize their proficiency with the Axiom platform.
- Stay informed about industry trends and best practices related to financial reporting, regulatory compliance, and Axiom software updates.
Developing and designing solutions aligned with business requirements. This involves collecting and scrutinizing data to support proposed solutions and system requirements
•Extracting and documenting business requirements and user stories, assessing risks and priorities to gain a thorough comprehension of stakeholder needs in support of solution development.
Understand Business Requirements of different stakeholders, diverse financial products and analyse the financial regulation related to the entity.
Equal employment opportunity information
KPMG India has a policy of providing equal opportunity for all applicants and employees regardless of their color, caste, religion, age, sex/gender, national origin, citizenship, sexual orientation, gender identity or expression, disability or other legally protected status. KPMG India values diversity and we request you to submit the details below to support us in our endeavor for diversity. Providing the below information is voluntary and refusal to submit such information will not be prejudicial to you.
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Regulatory Compliance Manager
Posted today
Job Viewed
Job Description
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.
Job DescriptionThe 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.
Responsibilities: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.
Manager - Regulatory Compliance
Posted today
Job Viewed
Job Description
KPMG entities in India are professional services firm(s). These Indian member firms are affiliated with KPMG International Limited. KPMG was established in India in August 1993. Our professionals leverage the global network of firms, and are conversant with local laws, regulations, markets and competition. KPMG has offices across India in Ahmedabad, Bengaluru, Chandigarh, Chennai, Gurugram, Jaipur, Hyderabad, Jaipur, Kochi, Kolkata, Mumbai, Noida, Pune, Vadodara and Vijayawada.
KPMG entities in India offer 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.
Role & Responsibilities
Equal employment opportunity information
KPMG India has a policy of providing equal opportunity for all applicants and employees regardless of their color, caste, religion, age, sex/gender, national origin, citizenship, sexual orientation, gender identity or expression, disability or other legally protected status. KPMG India values diversity and we request you to submit the details below to support us in our endeavor for diversity. Providing the below information is voluntary and refusal to submit such information will not be prejudicial to you. MBA (Finance)
FINRA Series 99 certification - preferred
Regulatory Compliance Specialist
Posted today
Job Viewed
Job Description
The Regulatory Compliance Specialist is a key position in the Regulatory Compliance organization. This position drives the daily compliance activities required under the company's trade compliance policy. The Regulatory Compliance Specialist is primarily responsible for resolving potential DPL matches and work with stakeholders that these are not exact matches. This position also reviews compliance holds relative to strategic or controlled goods and based on the nature of end-customers, determines whether a license or government authorization is required to make the sale or the export. This position is involved in conducting risk assessment of end-customers and categorize them accordingly based on a defined criterion. The Regulatory Compliance Specialist is responsible for analyzing metrics that track turnaround times in reviewing and releasing DPC and ECCN holds. Minimum supervision is required for this role.
Responsibilities:Address DPC escalations relating to potential matches when screening new customers, vendors or subcons.
Assist in determining the in-country HS codes for articles created in SAP system.
Perform ECCN review and determine license/regulatory requirements for all sales transactions.
Extract report from SAP system for DPC and ECCN Hold Metrics per month. Analyze metrics & determine actions further improve turnaround time or reduce DPC holds.
Prepare other trade compliance reports as required by the department.
Perform risk assessments on end-customers and categorize them according to a pre-determined criterion.
Perform ECCN validation of new articles created in SAP.
Knowledge, Skills and Experience:
3 to 5 Years of relevant work experience.
Associate degree with International Trade or Logistics field of study required.
Minimum Diploma in International Trade or Logistics or Supply Chain
Able to execute instructions and to request clarification when needed.
Able to use a 10-key quickly and accurately.
Possesses basic clerical and data entry skills.
Possesses strong data entry skills.
Able to recognize and attend to important details with accuracy and efficiency.
Able to communicate clearly and convey necessary information.
Able to converse and write effectively in English.
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 work independently with minimum supervision.
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.