Chief Manager/AGM -Regulatory Affairs

Gujarat Fluorochemicals Limited; India; On-site; INR 1,500,000 - 2,500,000; Full time

Job summary

Gujarat Fluorochemicals Limited is seeking an experienced professional to perform (eco)toxicological safety assessments of substances and products and lead regulatory compliance programs.

The role involves interpreting regulatory guidance, writing regulatory reports, supporting SDS authoring and product stewardship, and tracking evolving international chemical legislation. Total experience 8+ years in ensuring compliance with international chemical regulations.

Qualifications

• Experience in toxicological and ecotoxicological hazard evaluation.
• Ability to write regulatory reports and participate in scientific consultations with regulatory authorities.
• Stay updated on international chemical control legislation and regulatory guidance.
• Support SDS compliance and product stewardship across R&D and regulatory functions.

Responsibilities

• Perform (eco)toxicological safety assessments of substances and products.
• Summarize study data and draw scientifically sound conclusions for hazard evaluation.
• Provide internal advisory on human safety, exposure scenarios, and potential outcomes.

Skills

Strategic Thinking

Judgment

Analytical Ability

Planning & Organization

Interpersonal Skills

Education

PhD in Chemistry

Job description

Perform (eco)toxicological safety assessments of substances and products.

• Assessment of toxicological and ecotoxicological studies for hazard evaluation of substances:
  • Summarizing study data
  • Drawing scientifically sound conclusions based on regulation.
  • Data gap filling by using read across approach.
• To understand and be able to provide interpretation of regulatory guidance and emerging practice in the use of epidemiology, exposure scenarios and evaluate potential outcomes.
• Provide advice to internal stakeholders on human safety and toxicology across all phases of the research and development process, as well as providing expertise to support the development and registration of products.
• Experience of writing regulatory reports, prepare and participate in scientific consultations with regulatory authorities and industry.
• Prepare and participate in scientific consultations with regulatory authorities and industry.
• Defend key ingredients to regulatory authorities and public interest groups.
• Stay up-to-date with ongoing R&D efforts and projects in order to develop strategies for implementation of successful regulatory programs.
• Support compliance with GLOBAL REACH registration projects which includes registration, enforcement, training, internal audits, classification according to CLP.
• Support SDS Authoring compliance (GHS standards,EU/CLP, HCS/HazCom 2012) labels and other hazard communication information using a global product safety management system.
• Create and maintain Product Stewardship records relating to company products, intermediates and raw materials.
• Responsible for the continuing integration of Product Stewardship into business and R&D processes.
• Respond to internal and external product inquiries.
• Special projects and other duties as assigned by management.
• Stay up-to-date with new or changing international chemical control legislation through tracking and monitoring of the external regulatory environment,seeking out and reviewing regulatory information from external databases, industry/ regulatory authority communications, attendance of conferences and relevant national and regional trade associations and expert committee/panel meetings. Align this effort with that of other regulatory specialists in close collaboration with other key functions.
• Identify and communicate business opportunities and threats arising from current and future legislation and industry regulatory trends in line with business or company-wide objectives
• Maintain an understanding of the impact of new or changing legislation and manage and coordinate the strategically alignment with business managers regarding influencing regulatory developments or product defense through industry associations or expert groups.

Educational Qualifications

Preferred Qualification -

PHD in Chemistry

Functional Skills

Functional Skills Required -

Strategic Thinking, Judgment, Competitiveness Ethical Behavior Innovation, Analytical Ability Planning & Organization Flexibility, Ability to Deal with Change Interpersonal Sensitivity / Relationship Management Performance Standards, Tolerance of Str

Relevant and total experience

Total Number of experience required -

8+ years in ensuring compliance to current international chemical control or other relevant legislation, while developing and implementing a regulatory compliance program for the upcoming regulations.