Adil Mohammed

•Managed end-to-end regulatory submissions for NDAs, ANDAs, and amendments in compliance with FDA requirements.

•Conducted eCTD submissions for pharmaceuticals, ensuring adherence to regional and global regulatory standards.

•Led labeling tasks for regulatory submissions, including the development, review, and approval of product labels, in collaboration with cross-functional teams.

•Oversaw the management of product lifecycle activities, including variations, renewals, and compliance updates for pharmaceutical products.

•Reviewed and ensured the accuracy of regulatory documentation, including CMC sections, clinical trial applications, and post-market changes.

•Acted as the primary liaison between global regulatory agencies, including the FDA, Health Canada, and EU health authorities, to address queries and obtain approvals.

•Conducted regulatory assessments for changes to pharmaceutical formulations, manufacturing processes, and packaging to maintain compliance.

•Supported clinical trial operations by ensuring that labeling, packaging, and documentation aligned with regulatory guidelines.

•Ensured global regulatory compliance by coordinating cross-functional teams to resolve labeling and documentation challenges.

•Utilized Veeva Vault to manage regulatory documentation workflows, maintain version control, and ensure timely submissions.

•Implemented rebranding initiatives, including label redesigns and packaging updates, to comply with regulatory and market requirements.

•Conducted risk assessments for regulatory submissions and developed strategies to mitigate compliance challenges.

•Coordinated regulatory submissions for medical devices and combination products, ensuring alignment with global standards.

•Tracked and reviewed regulatory intelligence updates to adapt to evolving FDA and international regulatory policies.

•Collaborated with third-party vendors and external consultants to ensure timely and accurate preparation of regulatory dossiers.

• • Responsible for preparation and submission of NDA/ANDA/BLA as per US FDA guidance and checklists.
• • Created, reviewed, and approved ANDA and DMFs, Stability Protocols, and non-conformance responses to FDA.
• • Assembled quality documents related to Prior Approval Supplements, CBE-0 and CBE-30, and Annual Reports.
• • Assessed change controls and prepared submissions for ANDA from the change control process.
• • Assisted in submission of IND and NDA for transdermal products.
• • Wrote work instructions, released SOPs, and created forms to establish quality documentation.
• • Organized and ran cross-functional meetings to plan regulatory strategy for upcoming submissions.
• • Worked closely with the pharmacovigilance department in drafting quarterly and annual PADERs.
• • Maintained up-to-date knowledge of FDA standards and data requirements for different submissio