- Develop and implement regulatory strategies for global submissions in accordance with applicable regulations.
- Prepare, maintain, and coordinate regulatory submissions including INDs, CTAs, NDAs, MAAs, MATs, and LCM, ensuring compliance with regulatory guidelines.
- Identify regulatory scientific data needs and resolve regulatory issues.
- Serve as the primary Health Authority contact for routine communications related to submissions.
- Assist in preparing for and participating in regulatory authority meetings, inspections, and response to agency questions.
- Collaborate cross-functionally to ensure regulatory compliance and support strategic initiatives. Qualifications:
- Bachelor's degree in a scientific discipline and a minimum of 5 years of regulatory experience; or Master's degree with a minimum of 3 years of experience.
- Solid knowledge and understanding of the drug development process and regulatory requirements for EU, US, and ROW.
- Experience in the preparation and submission of documentation to support regulatory submissions.
- Excellent oral and written communication skills.
- Strong technical and analytical skills to independently identify and solve problems.
- Proven ability to manage multiple projects, identify and resolve regulatory issues.
- Strong organizational skills to maintain a high level of productivity, innovation, and priority-setting.
- Experience working cross-functionally on broad and strategic initiatives.
- Ability to work under pressure, meet time-sensitive deadlines, while maintaining a high level of quality.
- Fluent in English, written and spoken
Join our dynamic team at Parexel and contribute to the development of innovative therapies that have the potential to improve patients' lives worldwide. Apply now and take the next step in your regulatory career
#LI-REMOTE -
Senior Regulatory Affairs Consultant
2 weeks ago
Parexel REMOTE, United Kingdom RemoteWe are looking for a Senior Consultant Regulatory Affairs for Labelling. This is a client dedicated role. The role can be based in multiple locations in UK and EU (home or office based). In this role you will partner with Label Strategist to:Conduct international labeling operati ...
Regulatory Affairs Strategist - REMOTE, United Kingdom - Parexel
Description
Parexel is seeking a Regulatory Affairs Strategist (Regulatory Affairs Consultant) with extensive experience in EU, US, and ROW markets. As a Regulatory Strategist, you will play a crucial role in providing regulatory representation in cross-functional teams, developing regulatory strategies, and advising on regulatory expectations, requirements, and timelines. This is a client dedicated project. This role can be home or office based in various European locations.
Responsibilities: