840 Regulatory Affairs Professional jobs in India

We're Hiring | Regulatory Reporting Leader

Pune, India | Experience in BFSI |
CA Mandatory

An
industry-leading company
is seeking a
Regulatory Reporting Leader
to drive end-to-end
regulatory compliance, reporting, audits, and automation initiatives
.

Experience:
12+ Years PQE

What You'll Do:

Supervise & monitor regulatory reporting submissions

Lead audits, inspections & disclosure compliance

Implement automation & system-based reporting

Partner with cross-functional teams on regulatory data

Drive change management & ensure timely governance

What We're Looking For:

Strong background in BFSI regulatory reporting

Proven experience in audits, inspections & compliance

Expertise in automation, data monitoring & control frameworks

Excellent stakeholder management & analytical skills

Apply now if you're ready to lead regulatory excellence at scale

Business Unit: ESI HQ & Other

Division: Legal - Business

Challenge Yourself and Impact the Future
Element Solutions Inc. (NYSE: ESI) is a leading specialty chemicals company whose operating businesses (see below) formulate a broad range of solutions that enhance the performance of products people use every day. Developed in multi-step technological processes, our innovative solutions enable our customers' manufacturing processes in several key segments, including electronic circuitry, communication infrastructure, automotive systems, industrial surface finishing, consumer packaging, and offshore energy.

Customers of ESI's businesses use our innovation as a competitive advantage, relying on ESI to help them navigate in fast-paced, high-growth markets. The breadth of ESI's offerings provides strong strategic value to the end markets they serve. With over 5,500 people in operating facilities across more than 50 countries, ESI has established a growing legacy of creating technological advances for customers around the globe. Our people and technical sales teams are located close to our key markets, allowing us to maintain strong customer relationships and accelerate our product innovation process.

Who are we looking for?
The Regulatory Specialist supports the Product Regulatory department with customer surveys regarding regulations, internal queries regarding regulations, and supportive measures to put new products on the market.

What will you be doing?

• Author product SDSs that conform to global requirements
• Support secondary business with product regulatory needs
• Support customers with regulatory needs, such as SDSs, regulation information, compliant products
• Investigate TSCA status of products and imported raw materials and complete all necessary paperwork to assure compliance
• Assist with preparation and review regulatory submissions for Government and State Agencies
• Assist with project work such as Asia analyses for specific regulations

Who are You?

• Bachelor's degree in a scientific or technical discipline, such as Biochemistry, Chemistry, or Chemical Engineering.
• Proficiency in English (reading, writing, and speaking).
• Strong understanding of global chemical inventories and chemical industry regulations.
• Good knowledge of GHS regulations in Asia, Europe, and the US.
• Minimum of 3-5 years of experience in a similar role

What competencies will you need?

• Proficiency in reading, writing, and communicating in English.
• Strong interpersonal skills.
• Excellent problem-solving abilities.
• Outstanding organizational skills.
• High attention to detail.
• Strong project management capabilities.
• Ability to work independently with good time management.
• Skilled in researching new regulatory information online
• Ability to read, analyze, and interpret complex technical procedures, process and governmental regulations.
• Ability to write reports, business correspondence, and procedure manuals.
• Ability to effectively present information and respond to questions from customers.
• Ability to work effectively in a team environment

We are we Offering.
As part of our team here, in addition to a competitive Gross Salary you will be eligible to participate in a generous performance related bonus scheme. In addition, you will receive 3 comprehensive insurance benefits 1. GMC (Self/ Spouse and 2 Kids – INR 5 Lakhs coverage), 2. GPA – 5 Times of Annual Salary sum assured for Employee, 3. GTLI - 5 Times of Annual Salary sum assured for Employee. Also as an Employee benefit we offer free 2 meals on all working days.

Equal Opportunity Employer
Element Solutions Inc group of companies are E-Verify Companies and provide reasonable accommodation for qualified individuals with disabilities and disabled veterans in job applicant procedures. Equal Opportunity Employer: Minority/Female/Veteran/Disabled/Gender Identity/Sexual Orientation

provide adv regulatory supp to customers to ensure that all regulatory req are fulfilled, according to legal req & corp guidelines. Collaborate with commercial teams to provide effective regulatory support, ensuring compliance with relevant regs.

Required Candidate profile

University / Bachelor's Degree in Food Science or Food Technology.

Strong proficiency in PC skills, such as SAP and MS Office applications.

Purpose of the Job:

To provide regulatory support to customers, ensuring product compliance, quality, and

stewardship. The role involves addressing customer queries, monitoring global

regulations, and maintaining compliance for the products. It aims to enhance product

value, ensure safety, and drive business growth while upholding quality standards.

Primary Responsibilities:

1. Regulatory Compliance

• Working on REACH registrations.
• Registration /pre- registration/notification of chemicals in various countries as

per regulations Example: REACH (EU, Korea, Turkey, Eurasia, and many other

countries)

• SDS Authoring: Preparation and amendment of Safety data Sheet- in different

formats

• GHS and UN compliance
• Haz Communication: Preparation and amendment of hazard labels and DG

labels

• Understanding of regulations relevant to our industries personal care and home

care (chemicals) and ensuring compliance to those regulations., CLP, Cosmetic

Regulation, Detergent regulation, Transport regulations (IMDG, IATA), GHS, etc.

• Handling customer questionnaires and queries related to global regulations
• Product certifications - Halal & Kosher

2. Product Stewardship

Product stewardship as a practice where all those involved throughout the value chain

of a product take responsibility to understand and effectively reduce the Risk related to,

SHE, Quality, and Business, and to enhance value delivery to customers on key areas

including the following:

• Portfolio Value Positioning: it involves Data mining, Customer requirements

trends, Benchmarking, and Automation

• Competition Product profile Mapping
• Undertaking technical campaign on various improvement themes
• Working on global Product Eco-attestations / % Naturalness / Renewal Carbon

Index

• New product requirements e.g. Generally recognised as Safe, Free-from specific

impurities, product claims, etc.

3. Techno-legal Compliances
• Provide product pre-qualification and post-qualification regulatory

documentation support to our specified Domestic and International customers

globally.

• Taking care of Techno-legal compliance work viz. HS Code classification, FDA,

FSSAI, Pharmacopoeias, GRAS, Natural Product Certification, BIS, ICH,

Regulatory listing/status of products/components, etc. as required by the

Organization for Mandatory compliance and for Future Business Growth

• Leading Product Liability Management System
• Development of standard product dossiers of Galaxy Products and its periodic

reviews.

• Developing Document Management Systems and Automation programs to

fasten the customer responses

• Hazardous Material Management System
• Interacting/Visiting/closely working with Key customers to understand their

requirements

• Closely working with internal teams (QA/R&D/Manufacturing) in implementing

the regulatory support requirements and also suggesting new leads to them.

• Keeping abreast of new product guidelines/restriction and work with internal

teams for its implementation

4. Regulatory Compliance

Ensure Global compliance relevant to our industry by

• Understanding of regulations relevant to our industries personal care and home

care (chemicals) and ensuring compliance to those regulations. Example:

REACH (EU, Korea, Turkey, Eurasia), CLP, Cosmetic Regulation, Detergent

regulation, Transport regulations (IMDG, IATA), GHS, etc.

• Monitoring enforcement of new regulations and amendment of existing

regulations

• Preparation and amendment of Safety data Sheet- in different formats
• Preparation and amendment of hazard labels and DG labels
• Registration /pre- registration/notification of chemicals in various countries as

per regulations

• Handling customer questionnaires and regulation queries
• Product certifications- Halal & Kosher

Educational qualification: MSc in Chemistry or PhD in Chemistry.

Experience: 2-5 years

Required Competencies:
• Communication Skill

• Customer Focus
• Problem Solving
• Business Thinking
• Creativity
• Planning & Organizing
• Building Effective Teams

Coordination of CTA submissions, to ensure timely delivery and ensuring the content is appropriate to each individual regulatory agency while maintaining compliance with Organization policy and procedures

Accountable to the functional CTA Team Lead for overall work plans and to Global Regulatory Leads or Regional Representatives for definition of requirements within an agreed project

Accountability for agreed tasks and projects

Ensure independent communication, with a range of internal Organization staff, in support achievement of the assigned goals

Ensure compliance with Organization CTA process through timely action and completion of records in internal Organization systems

Ensure quality of own work to agreed timeframes, including compliance with Organization systems and record keeping

A good understanding of Clinical Trial Regulation (and Directive), DIA TMF Reference Model and CTA submission requirements for multiple countries/submission types

About the Company:

Our mission, in a single line, is to help people live longer and healthier lives. This mission defines and guides everything we do and everything that we hope to do:). Our aim is not only to expand lifespans, but more importantly, to expand health spans, by enabling people to live life of the quality that they desire.

Prior to the 21st century, the three traditional frontiers were considered to be land, sea and air. We believe that the most important frontier in the 21st century is the human body itself, and therefore the focus of our company is to look inwards, into the human body - which for us is the Fourth Frontier.

We have picked heart health as our primary focus area, since cardiovascular disease is the leading cause of mortality across the globe. Despite its importance, affordable products and services to monitor and improve heart health from the comfort of your home have not been available to consumers. Fourth Frontier is committed to solving this important problem.

We are looking for a highly organized and detail-oriented
Quality and Regulatory Specialist
to support the ongoing operation and improvement of medical devices Quality Management System (QMS). This is a hands-on role for an experienced professional who is passionate about ensuring compliance and driving quality.

Key Areas of Responsibility:

• Quality Management System (QMS) Management:
  Maintain the QMS to ensure the efficiency of the document control process and compliance with company procedures and related standards.
• Compliance and Audits:
  Lead QMS compliance with both internal procedures and external regulations. You'll ensure adherence to
  21 CFR Part 820, ISO 13485, ISO 14971, MDSAP, and EU MDR
  , along with other country-specific requirements. You'll also take the lead on audits and inspections by regulatory bodies and internal quality teams, preparing for them and ensuring documentation is ready.
• Corrective and Preventive Action (CAPA) and Non-Conformance (NC) Management:
  Lead CAPA investigations from issue identification through to root cause analysis, resolution, and effectiveness checks. You will also directly assist CAPA and NC owners to ensure their records are complete and comply with standards such as
  21 CFR Part 820, ISO 13485, ISO 14971, and HIPAA
  .
• Data Analysis & Improvement:
  Analyze trends in non-conformances and CAPA data to identify systemic issues and contribute to continuous improvement initiatives. You'll also prepare monthly metrics, maintain logs, and send reminders for required activities.
• Product Lifecycle Support:
  Provide essential quality and regulatory support throughout the medical device lifecycle. This includes managing documentation for
  Software as a Medical Device (SaMD)
  , supporting periodic software releases, and handling post-market activities.
• Cybersecurity and Data Privacy Compliance:
  Maintain a foundational understanding of an
  Information Security Management System (ISMS)
  , and ensure the company's QMS and product documentation adhere to relevant security and privacy laws and regulations.
• Cross-functional Collaboration:
  Work closely with cross-functional teams to uphold a consistent and compliant approach to quality. You will draft regulated documentation and assist with quality improvement initiatives across the organization.

Essential skills, qualifications and experience:

• Regulatory Knowledge:
  In-depth understanding of medical device regulations, including
  21 CFR Part 820, ISO 13485, ISO 14971, MDSAP, and EU MDR
  .
• QMS Expertise:
  Proven, hands-on experience in managing and improving a QMS, with a strong grasp of document control processes and how to maintain product-related quality documentation.
• Auditing:
  Experience leading audits and inspections by regulatory bodies. The ability to manage deliverables, track corrective actions, and ensure timely closure is essential.
• CAPA/NC Management:
  Direct experience leading CAPA investigations from root cause analysis through to resolution and effectiveness checks. You must have the ability to ensure documentation for CAPAs and NCs complies with various standards, including
  HIPAA
  .
• Data Analysis:
  Strong analytical skills to analyze trends in quality data and identify systemic issues.
• Communication:
  Excellent communication and collaboration skills to work effectively with various teams and external parties.
• Education:
  Bachelor's degree in a relevant field (e.g., Engineering, Life Sciences).
• Minimum of 3-5 years of experience in a Quality or Regulatory role within the medical device industry.
• Prior experience with
  EU MDR
  is required.
• Demonstrated experience managing and drafting regulated documentation.
• Experience with pre-market and post-market activities for medical devices.
• Basic understanding of medical device production activities.

Desirable
: Professional certifications such as
ISO 13485 and MDSAP Internal Auditor
,
ASQ (American Society for Quality)
are a plus.

What We Offer

• Opportunity to work with a pioneering healthcare technology company.
• Collaborative and innovation-driven work culture
• Exposure to global healthcare markets and cutting-edge medical solutions.

Key Responsibilities ?:
Author and compile Regional/Country PI as per regulatory authority labelling requirements and GSK process and standards.
Author and compile market-specific supporting documentation for labelling submissions in accordance with regulatory authority requirements and GSK process and standards.
Provide support to global and local GRA team members through preparation of other labelling documents as required
Complete quality and consistency checks of labelling document content.
Efficiently coordinate and manage labelling documentation and data in regulatory systems.
Provide advice regarding regulatory authority labelling requirements and GSK labelling process and standards to GRA global/local roles and via Regulatory Matrix Teams.
Effectively communicate with GSK staff (including GRA, Global safety and medical, and Local Operating Companies) to author, compile and deliver quality labelling documents. May communicate with Regulatory Agencies and third parties on behalf of GRA labelling staff.
Support other regulatory functions and participate in other projects and activities as needed, such as contributing to the implementation of changes to labelling processes and evaluation of new agency labelling requirements.
For some roles, may be required to perform translation of labelling text into identified languages.
May become a Subject Matter Expert in country/regional labelling content and process.