107 Regulatory Affairs Departments jobs in Mumbai
Regulatory Compliance
Posted 17 days ago
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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:
Regulatory Compliance Specialist
Posted today
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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.
Regulatory Compliance Manager
Posted today
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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.
Regulatory Compliance Officer
Posted today
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Job Description
**Principal Responsibilities**
- This role is heavily focused on regulatory compliance, trade monitoring and surveillance, SEBI rules & regulations.
- Advise on a full range of compliance and regulatory issues associated with Millennium’s growing research business in India and offshore FPI investing into India, working closely with offshore compliance product specialists/trading teams and onshore/offshore management.
- Research and analyze all relevant compliance issues, risks and developments, and provide recommendations to mitigate such issues/risks and prepare for such developments by drafting, amending, designing and implementing appropriate policies, procedures and controls;
- Undertake monitoring and surveillance in relation to such policies, procedures and controls;
- Conduct internal reviews on and, as appropriate, develop, enhance and maintain such policies, procedures and controls;
- Conduct internal investigations/risk assessments into a variety of compliance related matters;
- Maintain relationships with SEBI and other local regulators (as well as stock exchanges, depositories, etc.) and prepare for and respond to regulatory inquiries, inspections and surveys as relevant/appropriate;
- Closely collaborate and communicate with Asia compliance and global compliance teams;
- Prepare reports and maintain accurate records of compliance activities, including regulatory communications;
- Assist country, regional and global compliance teams on any ad hoc tasks and projects as may be assigned from time to time;
- Liaise with local counsel, custodians and brokers on regulatory/compliance issues;
- Participate in local industry groups as appropriate.
**Qualifications/Skills Required**
- 10-12 years’ experience at a financial institution or similar organization working on compliance matters;
- Strong knowledge of SEBI rules and regulations, in particular those relating to research and FPIs, and experience responding to inquiries from and managing investigations by SEBI and other local regulators;
- Experience conducting internal investigations;
- Ability to work with various departments in Millennium and build smooth working relationships;
- Able to prioritize in a fast moving, high pressure, constantly changing environment;
- Strong analytical and problem-solving skills;
- Growth mindset;
- Detail oriented;
- Strong communication skills; and
- Bachelor’s/Post Graduate degree(s) in Finance, Economics, Law or similar field (preferred).
Regulatory Compliance Applications Support
Posted today
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Job Description
**Job responsibilities**:
- Working knowledge in one or more general purpose programming languages, plus an interest in learning other coding languages and skills as needed
- Working knowledge of development toolset to design, develop, test, deploy, maintain and improve software
- Ability to work collaboratively in teams and develop meaningful relationships to achieve common goals
- Few years of programming experience in any modern language would be a great plus.
- Quick thinker, problem solver (even under pressure) and a fast learner under constantly changing environment.
- Ability to automate and build tools for improved productivity, or eagerness to learn it
**Required qualification**:
- BS/BA degree or equivalent experience
- Technically hands-on working with Linux, scripting (Shell, Python and/or Perl) and database systems (Oracle SQL/PLSQL).
- Exposure to AWS Cloud would be a plus.
In-House Counsel, Regulatory Compliance
Posted 2 days ago
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Tech Risk and Regulatory Compliance
Posted today
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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
Manager-Regulatory compliance-Paytm Money
Posted today
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Head of Quality and Regulatory Compliance
Posted 18 days ago
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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.