Senior Regulatory Affairs Associate - Publishing

Overview

DDReg Pharma is seeking a Senior Regulatory Affairs Associate specialized in Publishing to join their Regulatory Affairs team in Gurugram, India. The role involves managing the preparation, compilation, publishing, validation, submission, archiving, and lifecycle oversight of regulatory submissions worldwide, using eCTD publishing tools like DocuBridge and Lorenz. The associate ensures submissions meet requirements from health authorities such as FDA, EMA, and others, working closely with cross-functional groups to deliver precise and timely submissions.

Key Responsibilities

• Produce regulatory submission packages including initial applications, supplements, variations, annual reports, renewals, and responses utilizing DocuBridge, Lorenz, or similar tools.
• Compile and assemble regulatory submissions adhering to both regional and global standards.
• Manage electronic delivery of submissions ensuring accuracy and timely dispatch.
• Oversee end-to-end lifecycle of eCTD submissions, including sequences, replacements, amendments, and withdrawals.
• Verify completeness and correct allocation of all submission materials prior to dispatch.
• Ensure compliance with FDA, EMA, ICH, and other eCTD standards through technical validation and quality control checks.
• Review and validate submission file structure, metadata, hyperlinks, bookmarks, naming methodologies, and document placement.
• Identify and rectify any technical validation issues before submissions are sent to authorities.
• Coordinate with various stakeholders such as Regulatory Affairs, Medical Writing, CMC, Quality, Clinical, and Pharmacovigilance to prepare submissions.
• Participate in submission planning, project discussions, and milestone reviews to track timelines and risks.
• Proactively follow up on document collection and mitigate potential delays.
• Resolve technical publication and format issues, liaising with internal teams, vendors, and regulatory bodies as required.
• Provide operational support during critical submission phases and escalate significant issues appropriately.
• Support the deployment and ongoing maintenance of publishing systems and software tools.
• Act as a subject matter expert on eCTD publishing tools and regulatory submission processes, offering guidance and training internally.
• Develop and update training materials, standard operating procedures, instructions, checklists, and user manuals.
• Stay informed about updates in global regulatory standards and submission guidelines.
• Ensure complete and organized electronic submission archives with proper version control, lifecycle documentation, and tracking within Document Management or Regulatory Information Management Systems.

Eligibility

Open to applicants who have completed any graduate degree.