Job Summary:

Key Responsibilities:

• Prepare, review, and compile regulatory submissions in eCTD/aCTD formats for various markets including the US, UK, EU, and ROW.
• Ensure submissions are compliant with the regulatory guidelines and are ready for on-time dispatch.
• Manage and track the status of submissions and respond to regulatory agencies' queries promptly and accurately.
• Prepare and review key regulatory documents including Master Formula Card (MFC), Batch Manufacturing Record (BMR), Stability Protocols/Reports, Sampling Protocols, and Process Validation Protocols/Reports.
• Collaborate with cross-functional teams to gather necessary information and ensure the accuracy and completeness of documentation.
• Conduct thorough quality checks and validations on compiled submissions to ensure they meet all regulatory and internal quality standards.
• Create inter-document links, and manage the integrity and accuracy of submission components.
• Execute submission build activities, including the generation and validation of final submission outputs.
• Manage the submission lifecycle, ensuring compliance with timelines and regulatory requirements.
• Support the publishing tasks, including the management of electronic and paper submissions.
• Facilitate communication with regulatory authorities to resolve queries and provide additional documentation as required.
• Assist in the preparation and submission of responses to regulatory agencies in a timely manner.
• Identify opportunities for process improvements in submission preparation and publishing.
• Stay updated with the latest regulatory requirements and best practices in submission management.

?Skills & Competencies:

• Proficient in eCTD/aCTD submission management.
• Strong knowledge of global regulatory guidelines (US, UK, EU, ROW).
• Experience in preparing and reviewing regulatory documents such as MFC, BMR, Stability Protocols/Reports, Sampling Protocols, Process Validation Protocols/Reports, and PDR.
• Excellent attention to detail with strong organizational and project management skills.
• Ability to work effectively in a team-oriented environment with cross-functional teams.
• Strong communication skills, both written and verbal.
• Proficient in MS Office Suite and regulatory publishing tools.
• Ability to manage multiple projects and prioritize tasks effectively.

Qualifications:

• Experience in regulatory affairs publishing within the pharmaceutical/biotechnology industry.
• Familiarity with regulatory submission tools and databases.
• Knowledge of current global regulatory submission requirements and trends.