Anil Pakalapati

I am an experienced eCTD Publishing Specialist with expertise in preparing, compiling, and submitting regulatory dossiers in compliance with global health authority requirements, including FDA, EMA, and other regulatory agencies. I have a strong background in regulatory submissions, eCTD lifecycle management, and submission publishing tools (such as Freyr SUBMIT PRO, Lorenz docuBridge, or equivalent platforms).

With a keen eye for detail, I ensure that every submission package meets technical and regulatory standards, while adhering to strict timelines and quality expectations. My responsibilities include:

Publishing & Validation of regulatory submissions in eCTD/ NeeS/ Paper formats.

Lifecycle Management of sequences, ensuring accurate compilation and proper tracking.

Quality Control (QC) & Compliance checks to meet ICH and regional submission standards.

Collaboration with cross-functional teams (Regulatory Affairs, Clinical, CMC, etc.) to deliver accurate and complete submissions.

Submission Dispatch through ESG, CESP, and other agency gateways.

I am passionate about ensuring regulatory compliance, timely submissions, and smooth approvals that contribute to bringing safe and effective products to patients.

Team Lead – Regulatory Affairs | Freyr Software Solutions | Since May 2021

• Responsible for analyzing, planning and management execution of publishing activities of IND, NDA, BLA, ANDA and DMF. Acknowledge all the relevant information for submission shared by client and responsible for preparation of submission planner. Submission planner consist of all the Metadata and required documents information for submission shared by client. • Perform document level publishing activities like creating bookmarks, hyperlinking (Internal / external links) TOC, fast web view, troubleshoot document issues and perform quality control checks for submission ready documents as per the agency guidelines. Execute Submission Level Publishing activities like assigning Metadata documents and compilation of submission. • Involve in Publishing activities (Compilation of application as per submission planner, publishing of eCTD, Paper Output/ Dossiers and NeeS Submissions to various Agencies). Perform QC tasks for activities performed by Team members within the electronic publishing system and QC of published output. Knowledge of different document management tools like Freyr DMS. • Perform validation checks using Validation tools: EURS validator and Lorenz eValidator to ensure submissions are technically valid. Archival of Submissions, ESG receipt and acknowledgment letter in appropriate DMS. Participate knowledge sharing Trainings session presented by Operations Team. Archiving health authority correspondences and responses of the submissions. • Support early FDA engagement to align on development strategy, reduce regulatory risk, and support first-cycle approvals. Collaborate with cross-functional teams (e.g., R&D, QA, Manufacturing) to resolve regulatory challenges and streamline processes. Champion continuous improvement initiatives and introduce innovative solutions to enhance regulatory efficiency.

Manager – Regulatory Affairs | Makrocare Clinical Research Pvt Ltd | Jan 2019 - May 2021

• Publish ANDA, IND documents, DMF and other regulatory documents according to FDA, ICH, eCTD, and other applicable electronic publishing standards. Responsible for the pre-publishing (Bookmarks and Hyperlinks), compilation, post publishing, Validation of Regulatory submissions and lifecycle management submissions. Knowledge on Lorenz eValidator for validation. • Knowledge on FDA related ESG gateway, EU related CESP for dossier submissions. RIM knowledge based on Regulatory affair publishing tool. Performed EU AMSF, CEP Gap analysis, publishing and submission. Collaborate with regulatory organization, cross-functionally with key product managers to support global submission documentation requirements in identified markets. • Maintain supplier documentation in designated document databases specific to global product registration approvals. Build relationships with 3rd party suppliers to ensure qualifying supplier documentation is obtained such as international certificates, product labels, letters of authorization & requirement for global submission that support supplier country scope of distribution. • Gather and update global regulatory requirements to facilitate and maintain market access in global standards. Assesses changes in existing products to determine the need for new / revised licenses or registrations. Ensure regulatory requirements from existing 3rd party suppliers performs, updates and provides country license information in accordance with business timelines.

Senior Executive – Regulatory Affairs | Makrocare Clinical Research Pvt. Ltd | Apr 2012 - Oct 2016

• Compilation of dossiers for RoW and Emerging markets. Compilation of dossiers for Europe Market in CTD Format through MRP, DCP and National procedures. Author CMC sections (QOS and Module 3) for submissions, amendments, registration dossiers and post approval variations and renewals. Preparation and submission of variation dossiers to the Health Authorities. • Respect CMC regulatory strategies, assuring technical congruency and regulatory compliance and publishing requirements. Ensure adherence to regional regulatory requirements. Implement regulatory changes impacting product lifecycle. Manage post-approval activities including labeling updates and change control assessments. Assess regulatory impact / quality changes • Analyse, monitor and ensure compliance with regional regulations and company SOP. Monitor and support the agency meeting preparations and GMP certification processes. Design and define submission plans and timelines for change control activities. Support the product design change, labeling updates, sustainment, and improvement activities from key regulatory perspective.

Executive - Regulatory Affairs | Rajat PharmaChem Ltd | Feb 2010 - Apr 2012

• Communicate with different teams like R&D, QA, QC, PDC and client/customer to organize the required documents for dossier compilation purpose. Review product related documents like batch records, product development report, process validation, and other documents. Evaluate the regulations and led development of global regulatory strategies to bring products to market • Communicates changes to global regions and supports preparation of global notifications as needed. Understands fundamental regulatory requirements and different regulatory pathways. Communicate quantified risks and mitigation strategies associated with regulatory changes to partners. Manage technical files for regulatory products, supporting global registration applications.

Qualification

M Pharmacy in Pharmaceutics with (74%) | Prist University, Thanjore, Tamil Nadu during the academic year 2008-2010