Dedicated Regulatory Affairs Associate with two years of experience in regulatory department. I prepared regulatory dossiers, ensured compliance with international guidelines, and was involved in submission of pharmaceutical and nutraceutical products in various markets. In my role, as CMC global regulatory affairs associate, my responsibilities included the maintenance of regulatory databases, managing the lifecycle of products, preparation of Regulatory Drug Master Files (DMFs), draft responses to customer, regulatory packages, Letter of Authorisation (LOA), Annual Reports, amendments for regulatory submissions, Applicant Part and Restricted Part DMFs in compliance with eCTD and CTD requirements.I aim to utilise my technical skills and project management skills to support regulatory dossier preparation and submission processes. My future goals include advancing my regulatory affairs knowledge, obtaining professional certifications like Regulatory Affairs Certification (RAC).Key Skills:Communication skills: Regularly communicated project updates to stakeholders, ensuring transparency and alignment with project goals and objectives. Managed email communication with clients, responding to inquiries and addressing queries.Teamwork: Participated in the cross-functional process of obtaining regulatory approval for a new generic product at Laurus Labs, fostering communication and interpersonal skills with multiple departments and the development of project management abilities.Organisational skills and time management: Maintained and organised executive email, calendar, documents and records, improving time management, and audit compliance Adaptability: Demonstrated adaptability by swiftly acclimatizing to evolving project requirements and adjusting communication strategies to effectively convey project updates to stakeholders.
-
Regulatory Affairs ExecutiveLactonova Feb 2023 - Jul 2023Hyderabad, Telangana, Indiao Prepared documents for certifications and licences including FSSAI, FSC, ISO, HACCP, Pharmexcil, WHO-GMP, Trade Marks and GMP-Ayush Licenses, Certificate of origin (COO) for export purpose.o Addressed queries from regulatory agencies concerning dossiers and certificate renewals, providing timely and accurate information.o Cross-checked RDA value limits in various product compositions as per domestic and export regulatory requirements. o Collaborated with the designer for artwork development and review of cartons, foils, literature, labels, and visual aids.
-
Regulatory Affairs AssociateLaurus Labs Jun 2021 - Oct 2022Hyderabad, Telangana, Indiao Maintained regulatory databases, product life cycles, and review of technical documents, specifications, protocols and DMFs. o Prepared, published, reviewed dossiers, and archived regulatory activities, ensuring all submissions met quality standards and regulatory requirements.o Preparation of Applicant Part, Restricted Part DMFs, and Technical packs as per eCTD and CTD requirements. Compilation and regulatory submissions for the regions like USA, EU, Canada, Japan and ROW markets.o Managed product data throughout its lifecycle ensuring accuracy, completeness and consistency. Ensured changes to product information such as revisions, updates and version control were properly documented, communicated and implemented
-
Clinical ObserverHospital Aug 2017 - Jul 2018Greater Hyderabad Areao Dispensed medications accurately as per doctors' prescriptions, ensuring proper dosage and instructions were followed.o Maintained comprehensive records of medications, including batch numbers, and routinely checked and removed expired medications to ensure patient safety.o Provided clear and detailed explanations of dosage regimens and potential side effects to patients, enhancing their understanding and compliance with treatment plans.o Managed the billing process for dispensed medications, ensuring accurate and timely recording of transactions for inventory and financial tracking purposes.
Divya Ancha Education Details
-
Msc Project Management -
Pharmaceutical Analysis
Frequently Asked Questions about Divya Ancha
What is Divya Ancha's role at the current company?
Divya Ancha's current role is Global Regulatory Affairs Associate | Project Management l Member of TOPRA l MSc in Project Management & M.Pharm in Pharmaceutical Analysis.
What schools did Divya Ancha attend?
Divya Ancha attended Robert Gordon University, Osmania University, Hyderabad.
Free Chrome Extension
Find emails, phones & company data instantly
Aero Online
Your AI prospecting assistant
Select data to include:
0 records × $0.02 per record
Download 750 million emails and 100 million phone numbers
Access emails and phone numbers of over 750 million business users. Instantly download verified profiles using 20+ filters, including location, job title, company, function, and industry.
Start your free trial