Ashwini Nikam
Regulatory Affairs Professional
Navi Mumbai
Summary
Strategic Regulatory Affairs Professional with proven expertise in the specialty chemicals industry. Excel in navigating complex regulatory landscapes while fostering valuable stakeholder relationships. Demonstrated success in team leadership and implementing effective communication strategies across organization. Technical foundation supported by a Master of Science in Organic Chemistry, enabling comprehensive understanding of chemical processes and regulatory requirements.
Career aspirations include leveraging expertise to enhance compliance and innovation within the field.
Overview
7
7
years of professional experience
4
4
Certifications
Work History
Deputy Manager
Clariant India Private Limited
01.2022 - Current
- Leading product compliance initiatives with key regulatory authorities viz. CDSCO, NCB, CIB, and RC, etc. ensuring adherence to governmental requirements.
- Well-versed in country-specific regulations and working as a SME for regions such as India, Japan, Australia, New Zealand, and the Philippines, while managing chemical compliance and SAP data integrity.
- Providing strategic regulatory guidance to business units and the research team for new product launches and market expansion initiatives across global markets.
- Conducting comprehensive monitoring of global regulatory landscapes, facilitating the timely implementation of regulatory changes across the organization.
- Delivering significant contributions to strategic global projects, enhancing organizational efficiency and compliance standards.
- Supported in the preparation of PS code for the ICC (Indian Chemical Council) Responsible Care re-certification audit, 2023.
- Instrumental in developing an award-winning application that secured Clariant the prestigious ICC - Epsilon Carbon Certificate of Merit for Product Safety and Stewardship Code excellence under Responsible Care in the year 2022.
- Managing purchase requisition creation and vendor payment administration.
Team Lead - Product Data - CoC
Clariant India Limited
07.2020 - 01.2022
- Led the global Product Data Process team, collaborating with global stakeholders across Europe, North America, SEAP, and India.
- Managed a complex operational transformation from a vendor-based (TCS-based) to an in-house model, delivering seamless service continuity and improved efficiency.
- Pioneered virtual team development by successfully recruiting, onboarding, and mentoring 10 professionals during pandemic restrictions, coordinating remote asset deployment, and implementing comprehensive digital training frameworks.
- Developed comprehensive process documentation, including SOPs, training materials, and workflow maps, to standardize operations.
- Established robust issue resolution protocols, and maintained operational efficiency through strategic workflow management.
- Consistently achieved service level agreements and performance targets through effective resource allocation and team coordination.
- Implemented quality assurance frameworks, ensuring regulatory compliance across all deliverables.
- Strengthened global partnerships through proactive engagement with subject matter experts across regions.
- Drove operational transparency through weekly performance analytics and stakeholder communications.
- Managed critical SAP EH&S infrastructure, optimizing data quality and system accessibility for diverse business operations.
- Managed end-to-end project lifecycle, including volume scaling, resource optimization, and quality control measures.
Executive - Product Stewardship
Clariant India Limited
06.2018 - 06.2020
- Developed and maintained comprehensive Safety Data Sheets, managing product documentation in the SAP EHS module for new materials, finished products, and laboratory samples.
- Led the development of Standard Operating Procedures and delivered strategic presentations to global stakeholders.
- Managed customer compliance requirements through the issuance of specialized certifications, including: RoHS compliance documentation, Halal certifications, Restricted Substances Not Used (RSNU) declarations, and Substances of Very High Concern (SVHC) statements, etc.
Education
Master of Science - Organic Chemistry
University of Mumbai
Mumbai, India 04.2001 -
Bachelor of Science - Chemistry
University of Mumbai
Mumbai, India 04.2001 -
HSC -
Sonopant Dandekar Shikshan Mandali
Palghar, India 04.2001 -
SSC -
Kenam English High School
Palghar, India 04.2001 -
Skills
- Regulatory compliance
- Specialist in SAP EH&S module
- Sound knowledge of Clariant's Data systems and Product Portfolio
- Expertise in GHS
- Strategic thinking
- Project management, process improvement, and data analysis
- Employee training, team management
- Time management
- Effective communication and presentation skills
- Microsoft office expertise
- Multitasking and problem-solving
- Result-oriented
Accomplishments
- Honored with "Extraordinary Contribution Award" by Head of Regulatory Affairs, APAC (2024)
- Recognized with "Extraordinary Contribution Award" by Manager Regulatory Affairs, India (2024)
- Advanced to Deputy Manager position, demonstrating leadership excellence (2023)
- Leadership & Performance Excellence (2020-2022):
- Received Recognition Award for exceptional performance in CRO Workshop execution, Mumbai (2022)
- Awarded Special Recognition for outstanding team leadership contributions (2021)
- Promoted to Team Lead position, advancing from Executive role (2020)
- Winner, Special Recognition Award - "Project Best from Waste," Spark Nova Competition
- Two-time recipient of "Product Steward of the Month Award" - achieved among 17 team members
- Secured First Rank in T.Y.BSc across Palghar District
- Achieved First Rank consistently through undergraduate studies (F.Y.B.Sc, S.Y.BSc, T.Y.BSc)
- Topped SSC examination at school level
Early Career Distinctions (2019):
Academic Excellence:
Certification
Selected for exclusive month-long strategic training program at Clariant GmbH, Frankfurt, strengthening global expertise
Timeline
Completed specialized Transcultural Awareness Training led by Ms. Vaishali Karmarkar, developing cross-cultural business communication skills[Area of certification] Training - [Timeframe]
02-2025
Deputy Manager
Clariant India Private Limited
01.2022 - Current
Earned GHS (Globally Harmonized System) certification under industry expert Ms. Rashmi Naidu, demonstrating advanced chemical classification and labeling proficiency.[Area of certification] Training - [Timeframe]
03-2021
Team Lead - Product Data - CoC
Clariant India Limited
07.2020 - 01.2022
Selected for exclusive month-long strategic training program at Clariant GmbH, Frankfurt, strengthening global expertise
12-2019
Executive - Product Stewardship
Clariant India Limited
06.2018 - 06.2020
Master of Science - Organic Chemistry
University of Mumbai
04.2001 -
Bachelor of Science - Chemistry
University of Mumbai
04.2001 -
HSC -
Sonopant Dandekar Shikshan Mandali
04.2001 -
SSC -
Kenam English High School
04.2001 -
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