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Divya Ancha Email & Phone Number

Global Regulatory Affairs Associate | Project Management l Member of TOPRA l MSc in Project Management & M.Pharm in Pharmaceutical Analysis
Location: United Kingdom 3 work roles 2 schools
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Role
Global Regulatory Affairs Associate | Project Management l Member of TOPRA l MSc in Project Management & M.Pharm in Pharmaceutical Analysis
Location
United Kingdom

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Divya Ancha is listed as Global Regulatory Affairs Associate | Project Management l Member of TOPRA l MSc in Project Management & M.Pharm in Pharmaceutical Analysis based in United Kingdom. AeroLeads shows a matched LinkedIn profile for Divya Ancha.

Divya Ancha previously worked as Regulatory Affairs Executive at Lactonova and Regulatory Affairs Associate at Laurus Labs. Divya Ancha holds Msc Project Management from Robert Gordon University.

Profile bio

About Divya Ancha

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.

3 roles

Divya Ancha work experience

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Regulatory Affairs Executive

Lactonova

Hyderabad, Telangana, India

o 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.

Feb 2023 - Jul 2023

Regulatory Affairs Associate

Laurus Labs

Hyderabad, Telangana, India

o 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

Jun 2021 - Oct 2022

Clinical Observer

Hospital

Greater Hyderabad Area

o 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.

Aug 2017 - Jul 2018
2 education records

Divya Ancha education

Msc Project Management

MSc Project Management accredited by the Association for Project Management (APM) and Project Management Institute (PMI) Modules include.

Master Of Pharmacy - Mpharm, Pharmaceutical Analysis

Masters Analytical Chemistry accredited by the National Assessment and Accreditation Council (NAAC), approved by The Pharmacy Council.

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What is Divya Ancha's role at their current company?

Divya Ancha is listed as Global Regulatory Affairs Associate | Project Management l Member of TOPRA l MSc in Project Management & M.Pharm in Pharmaceutical Analysis.

Where is Divya Ancha based?

Divya Ancha is based in United Kingdom.

What companies has Divya Ancha worked for?

Divya Ancha has worked for Lactonova, Laurus Labs, and Hospital.

How can I contact Divya Ancha?

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What schools did Divya Ancha attend?

Divya Ancha holds Msc Project Management from Robert Gordon University.

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