Neelofar Shaikh

[email protected] • +971567510563 • Sharjah, United Arab Emirates

PROFESSIONAL SUMMARY

Regulatory Affairs Specialist with extensive expertise in navigating EU, USA, Gulf, and global regulatory standards to ensure full compliance and accelerate product approvals. Proven track record in leading regulatory submissions that reduced approval times by 30%, while maintaining rigorous document control and quality standards. Adept at cross-functional collaboration and problem-solving to streamline R&D processes and support innovative product development. Committed to leveraging deep regulatory knowledge and strong communication skills to drive regulatory excellence and business growth.

WORK EXPERIENCE

R&D – Regulatory Affair Specialist
01/2013 - Present
European Perfume Works Co LLC , Sharjah, United Arab Emirates
• Led successful US FDA Cosmetic Facility Registrations under MOCRA 2022, managing submissions for over 25 facilities, ensuring 100% compliance and timely approvals for USA market entry
• Developed and implemented comprehensive formula and label review processes aligned with US FDA and California regulations, reducing non-compliance risks by 30% and enhancing product safety and marketing accuracy
• Directed OTC drug regulatory submissions, including establishment registrations and product listings for sunscreens, achieving full compliance with FDA monographs and expediting market launch by 20%
• Spearheaded EU Cosmetics Regulation 1223/2009 compliance initiatives, overseeing safety assessments, PIF and CPSR documentation for 40+ products, resulting in zero regulatory rejections and streamlined CPNP/SCNP notifications
• Managed cross-functional teams to monitor evolving global regulatory landscapes (FDA, EU, REACH, EPA), providing strategic guidance that improved regulatory adherence and reduced audit findings by 25%
• Championed label and claims reviews for EU and UK markets, aligning marketing communications with Article 19 requirements, which increased customer trust and minimized legal risks
• Orchestrated pre-market regulatory plans and technical documentation for new product developments, accelerating approval timelines by 15% and supporting successful product commercialization
• Established robust quality management and compliance frameworks, enhancing internal regulatory training and ensuring continuous alignment with international standards and best practices
Production Chemist and Documentation Executive
01/2010 - 12/2012
Cipla Pvt. Ltd. , Bangalore, India
• Led calibration and qualification of critical laboratory instruments such as pH meters, weighing balances, and UV cabinets, ensuring 100% compliance with cGMP standards and reducing instrument downtime by 15%
• Implemented rigorous environmental monitoring protocols utilizing settle plate and air sampling techniques, consistently meeting cleanliness standards and facilitating successful FDA and WHO audits
• Developed and revised SOPs and batch manufacturing records, improving documentation accuracy and decreasing batch release delays by 20%
• Collaborated with QA and QC teams to optimize batch release workflows, enhancing on-time product delivery by 10%
• Executed deviation, change control, CAPA, and OOS investigations, driving corrective actions that reduced non-conformance incidents by 25%
• Supported FDA and WHO audits by preparing detailed documentation and ensuring strict regulatory compliance across production and quality systems

EDUCATION

Master of Science
01/2008 - 12/2010
SDM College Ujire [Affiliated to Mangalore University]
Bachelor of Science
01/2005 - 12/2008
M.M Arts and Science College, Sirsi under Karnatak University Dharwad

SKILLS