Senior Manager/Team Lead – Regulatory Affairs – Regulated Markets
To Manage Regulatory Affairs for EU/Canada/Australia Markets in compliance to applicable regulations and guidelines. This position will assist with the review of CMS documentations, 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 & Responsibilities
- Providing high-quality CMC review of technical documentation for regulatory filings to European Medicinal Agency (EMA), UK MHRA, National Agencies of EU Member states, Canada, Australia for DDReg clients.
- 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 regulatory strategies, processes and timelines for EU/UK/Australia/ Canada and global approval.
- 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.
- Previous experience that provides the knowledge, skills and abilities to perform the job (comparable to 5+ years’) or equivalent combination of education, training, & experience.
- Experience working in the pharmaceutical/CRO industry preferred.
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
As may be required from time to time – the incumbent may be required to working slots catering to different time zones
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