Job Description

Job purpose

To Manage Regulatory Affairs for global Markets in compliance to applicable regulations and guidelines. This position will assist with the review of CMC documentation, preparation and submission of eCTDs, Variations, site transfers and post approval gap analysis. 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 global markets especially to European Medicinal Agency (EMA), UK MHRA, National Agencies of EU Member states, Canada, Australia for DDReg clients

• Review of technical Documents including Product Development Reports, tech transfer documentations, Stability protocols etc.
• Running De-centralized Procedures, MRP and procedures for national filings in EU Members states, Health Canada, TGA Australia
• Actively contribute to the development and implementation of global regulatory strategies.
• Prepares and compiles new CTDs, Variations (Major/Minor/Site Transfers) filings 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 above mentioned agencies, 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.
• 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 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 with 5 years of Experience
• Previous experience in formulation Development and tech transfer of developed formulations (OSDs, Injectable, Topical, Liquids, Inhalational etc) that provides the knowledge, skills, and abilities to perform the job (comparable to 5+ years’) or equivalent combination of education, training, & experience.

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

Direct reports

1-4 to start with.

Location

Gurgaon, Haryana (INDIA)