The Regulatory Affairs – Clinical Trial Manager enables the development of organizational and people capabilities of the future, we support and optimize the delivery of projects and initiatives to the organization both on the molecule and molecule-enabling portfolio.

We are responsible for enabling the future of clinical trials from a regulatory perspective by pushing boundaries to deliver medical solutions now in order to transform patients’ lives.

KEY RESPONSIBILITIES SHALL INCLUDE:

• Responsible to lead and implement all global CMC submission activities for assigned projects/products, while applying the global strategy into submissions
• Ensuring the required documentation and any content, quality and/or timelines for global submissions are communicated to the appropriate teams and tracked accordingly
• Working closely with the Clinical Trials Coordinator and other clinical project related teams, will have strategic responsibility for clinical trial related regulatory tasks
• Management of Core documents and amendments for USA, EU, China, Australia & other regulated markets, as applicable. This includes planning, filing, compilation, dispatch, coordination with internal departments and the affiliates, tracking of submissions and approvals in appropriate systems. Including product applications
• Review the ANDA/IMPD/IND/NDA/CMC documentation for submission in applying global regulatory strategies, assuring regulatory compliance and Product Life Cycle Management
• Authoring and Review of IND/IMPD/NDA and ANDA submissions to US FDA, EMEA, China FDA & other regulated markets, as applicable
• Authoring and Review of pre-submission Meeting requests and briefing packages for IND/CMC/NDAs and ANDAs
• Complex and complex submissions, independently fulfill the following responsibilities:
• Conduct research of existing product data relative to global or regional regulatory requirements for the preparation of gap analyses, product development plans, and other regulatory submissions
• Contribute to or prepare administrative and technical components of regulatory agency submissions for the IND, for pre-approval submission packages, for product registration applications, and for post-approval maintenance. Prepare briefing packages for regulatory agency meetings or scientific advice and contribute to or support the agency interactions. Similarly for other submissions like ANDA, CMC, etc
• Manage and/or operationalize the delivery of day-today regulatory activities for assigned project according to agreed timelines, scope of contract, budgets, and strategies
• Participate as regulatory support on multidisciplinary project teams, which may include clinical and other technical experts, to develop products throughout their life cycle
• Act as a subject matter expert and help the team members with day-to-day trouble shooting activities, presenting solutions to project related problems
• Prepare estimates for conducting regulatory services as part of single or multiple service proposals
• Support meetings with clients to discuss proposals, the status of ongoing projects, and as part of general business development activities
• Ensure compliance with appropriate global regulatory requirements and the company’s policies and processes
• Prepare training materials and share best practices in the regulatory area, both internally and externally
• Participate as regulatory support in internal or external project audits
• Participate as regulatory support on internal cross-functional initiatives
• Contribute to the creation and/or maintenance of SOPs and other process related documentation as required
• Provide support in oversight to team members in the execution of their project responsibilities
• Capable of identifying when to ensure line support required to provide additional guidance and direction
• Regulatory strategic support for IND/IMPD/NDA and ANDAs during development stage of various dosage forms specifically in Ophthalmic
• Handling of Health Authority queries with strategies and response package preparation
• Evaluation of change controls and providing regulatory strategies for post approval changes submissions
• Responsible for assisting developmental strategy of various dosage types including complex dosage forms
• Responsible for Authoring and final review of Meeting Requests and Packages for Pre- IND, Pre-ANDA meeting requests for Complex Products per GDUFA & PDUFA. Must have current knowledge of GDUFA & PDUFA guidelines, as well as other similar global guidelines
• Manage Pharmacovigilance documentation, including Drug Safety Update Reports, Periodic Safety Update Reports, Investigation Brochures, Clinical Trial Reporting, and clinical trial applications

QUALIFICATION REQUIREMENTS

• Pharmacy degree, preferably in a science-related field or equivalent experience in science/regulatory field
• Demonstrated experience in contributing to the preparation of regulatory submissions including, for example IND, PMA, NDA, MAA, and CTD, including electronic submissions
• Good negotiating and communication skills with ability to challenge, if applicable
• Effective communication, organizational, and interpersonal skills
• Ability to work independently and to effectively prioritize tasks
• Ability to manage multiple projects
• Knowledge and ability to apply GCP/ICH/GDUFA/PDUFA and applicable regulatory guidelines
• Additional advantage, if has NMPA guidelines knowledge and application experience
• Excellent interpersonal / communication skills including excellent written and verbal communication skills
• Excellent customer service skills, with the ability to work both as a team member and independently
• Good quality management skills
• Advanced skills in Microsoft Office Applications
• Ability to interact with staff from multiple departments and offices to establish project standards
• Good initiative, adaptability, and pro-activity
• Strong analytical skills, good attention to detail
• Ability to work concurrently on projects, each with specific instructions that may differ from project to project
• Fluent in speaking, writing, and reading English