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Shweta Rane, regulatory affairs manager

Shweta Rane

regulatory affairs manager·Influx Healthtech Limited

India

Bachelor's degree, Pharmacy

Work experience

Total years of experience: 5 years, 11 months

regulatory affairs manager

September 2022 - Present

Influx Healthtech Limited

Mumbai, India

September 2022 - Present

Regulatory Affairs Professional with 4+ years of experience in regulatory compliance, product registrations, documentation management, and licensing across Cosmetics, Nutraceuticals, Dietary Supplements, Ayurvedic Products, Veterinary Products, Gym Supplements, and Home-Care Products.

Experienced in coordinating with regulatory authorities, managing product dossiers, ensuring compliance with applicable regulations, reviewing labeling and artwork, handling technical documentation, and supporting product launches. Strong understanding of Indian regulatory frameworks, quality systems, and cross-functional collaboration with R&D, Quality Assurance, Manufacturing, and Marketing teams.

Passionate about ensuring regulatory excellence while enabling business growth through compliant and efficient product commercialization. Recognized for attention to detail, strong documentation practices, problem-solving abilities, and commitment to maintaining high standards of quality and compliance.

Open to opportunities in Regulatory Affairs, Compliance, Documentation Management, Product Registration, and Quality Systems within the Healthcare, Cosmetics, Nutraceutical, FMCG, and Consumer Goods sectors.

Company industry:
FMCG

Regulatory Affairs Head

January 2021 - Present

Influx Healthtech Ltd.,

Mumbai, India

January 2021 - Present

Secured 1000+ product approvals across
nutraceutical, ayurvedic, and cosmetic categories,
ensuring 100% compliance with FSSAI and FDA
guidelines.
Reduced regulatory approval timelines by 20-30% by
streamlining submission processes and proactive
engagement with authorities.
Led regulatory compliance strategy for domestic
and export markets, enabling smooth import/export
clearances.
Conducted 20+ successful internal audits with zero
major non-compliances, strengthening the
companys quality and regulatory framework.
Trained and guided 10-1 5 business team members
on FSSAI regulations, product guidelines, and
nutritional profiles, resulting in improved customer
query resolution by 20-25%.
Conducted analytical testing using HPLC and
spectrophotometric techniques to ensure product
quality, accuracy, and compliance with international
regulatory standards.
Supported the successful completion of multiple
regulatory audits, including GMP, WHO-GMP, NSF
22000, and NAFDAC, by ensuring documentation
readiness, compliance adherence, and process
alignment.

Company industry:
FMCG
Job role:
Quality Control

Compounder

July 2020 - February 2021

Health Clinic

Mumbai, India

July 2020 - February 2021

Assisted physicians during patient
examinations and procedures,
ensuring efficient clinic operations.
Prepared and dispensed
medications accurately while
maintaining patient safety and
proper documentation

Company industry:
Other Healthcare Services
Job role:
Management

Education

University Of Mumbai

May 2022

May 2022

Bachelor's degree, Pharmacy

India

St. Wilfred's Institute of pharmacy

May 2022

May 2022

Bachelor's degree, Pharmacy

India

University Of Mumbai

February 2018

February 2018

High school or equivalent, Biochemistry And Pharmacy

India

Skills

Microsoft Excel
Expert
Microsoft Excel
Expert
Quality Auditing
Expert
Quality Auditing
Expert
BUSINESS ADMINISTRATION
Expert
BUSINESS ADMINISTRATION
Expert
CROSS FUNCTIONAL TEAM LEADERSHIP
Expert
CROSS FUNCTIONAL TEAM LEADERSHIP
Expert
MANAGEMENT
Expert
MANAGEMENT
Expert
QUALITY MANAGEMENT SYSTEMS
Expert
QUALITY MANAGEMENT SYSTEMS
Expert
TRAINING AND DEVELOPMENT
Expert
TRAINING AND DEVELOPMENT
Expert
REGULATORY COMPLIANCE
Expert
REGULATORY COMPLIANCE
Expert
Environmental Auditing
Expert
Environmental Auditing
Expert
Microsoft Word
Expert
Microsoft Word
Expert
ERP Management
Expert
ERP Management
Expert
PHARMACY EXPERIENCE
Expert
PHARMACY EXPERIENCE
Expert

Languages

English
Expert

Hobbies

  • Traveling