Job Description

Job purpose

To Manage Regulatory Affairs for Emerging (RoW) Markets/Regulated Markets (Eu/US/Canada/Japan/UK/Australia)  in compliance to applicable regulations and guidelines. The responsibility include review of technical documents/dossiers, preparation and submission of Submission dossiers in CTD format, ePublish them (wherever applicable), response to queries, post approval life cycle management etc. This position will also provide support of the regulatory function through document management, electronic submission compilation and management, and other group management activities as required. Position will be required to work with Regulatory Affairs, Quality Assurance, Quality Control, Manufacturing, Research and Development groups of the client organization of DDReg.

Duties and responsibilities

• Providing high-quality CMC review of technical documentation for regulatory filings to various markets – key market being Saudi & GCC, for DDReg clients
• Actively contribute to the development and implementation of regulatory strategies, processes and timelines for grant of MAs.
• Prepares and compiles new CTD dossiers, renewals and variations ensuring that they are in conformance with applicable regulatory guidelines and that the highest quality standards are met.
• Critically reviews documentation intended for submission to the respective agencies for internal consistency, for consistency to relevant guidelines and to promote regulatory excellence.
• Demonstrate subject matter and area expertise.
• Collaborate with internal and external clients,
• Supporting and enabling effective and efficient communication that results in operational excellence.
• Manage multiple projects with the help of team, track the status of each project, provide update to management in a time bound manner, monitor efficiency of team members.
• Providing technical consultation and provides substantive advice on strategy, regulations and industry best practices.
• Demonstrate high level knowledge of country regulations and regulatory guidelines as updated from time to time on various agencies’ website.
• Monitor competitive regulatory practices, and actively review internal and external factors to mitigate potential problems.
• Ensure that draft labeling complies with all applicable regulations and guidelines

Education & Experience

• Bachelor’s or Master’s degree in Pharma
• Previous experience of minimum 7 years that provides the knowledge, skills, and abilities to perform the job.

Knowledge, Skills and Abilities

• Excellent technical data interpretation skills
• Strong project management skills
• Excellent interpersonal skills including problem solving
• Strong negotiation skills
• Excellent oral and written communication skills with strong presentation skills
• Significant knowledge of global, regional, national and other document development guidelines
• In-depth knowledge in a specialty area such as preclinical, therapeutic, regulatory submissions, communications, etc.
• Great judgment and decision-making skills
• Excellent computer skills and skilled with client templates; Good knowledge of document management systems and other relevant applications (e.g. Excel, Outlook)
• Ability and desire to work in a team-oriented environment.
• Excellent written and verbal communication skills
• Highly proficient with Microsoft Word, PowerPoint and Excel.
• Demonstrates ability to evaluate information and data with a defined, studied process and report results in a thoughtful, organized manner
• Possesses a collaborative, results-driven style.
• Flexible, Adaptive, Ability to work under pressure and provide quality outputs within tight timelines

Other requirements

As may be required from time to time – the incumbent may be required to working slots catering to different time zones

Location

Gurgaon, Haryana (INDIA)