To provide Regulatory Affairs support for EU in compliance to applicable regulations and guidelines. This position will 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
- Compilation of module 1 for Life cycle applications suitable for submission in Europe until End of procedure/approval.
- Compilation of module 1 New MAA suitable for submission in Europe until End of Procedure/approval.
- Necessary communications & subsequent follow up (keeping Reporting Manager in loop) with different stake holders (e.g. Manufacturing, QA, QC, Procurement, ADL, etc.) to get required data / documents for compilation of package
- Publishing of eCTD sequence and upload onto agency portal.
- Updating company databases with approved regulatory information as per company SOP.
- Compilation of suitable for submission in Europe until End of procedure/approval.
- Compilation of new CTDs, Life cycle applications (i.e Variations -Major/Minor/Site Transfers) ensuring that they are in conformance with applicable regulatory guidelines and that the highest quality standards are met.
- Compilation of New MAA suitable for submission in Europe until End of Procedure/approval.
- 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.
- Demonstrate high level knowledge of country regulations and regulatory guidelines as updated from time to time on agencies website.
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
Reports To : Director