Job in Germany : IT Manager

Cross Border Talents; Comunidad Valenciana; Híbrido; EUR 30.000 - 50.000; Jornada completa

Descripción de la vacante

An established industry player is looking for a Principal Regulatory Affairs Consultant to lead projects in the pharmaceutical sector. This role involves providing strategic guidance on post-approval CMC activities, ensuring compliance with regulatory requirements, and mentoring junior team members. The ideal candidate will have a strong background in regulatory affairs and project management, with the ability to communicate effectively with clients and stakeholders. This position offers flexibility as it can be home or office-based across various European locations, making it an exciting opportunity for professionals seeking to make a significant impact in the industry.

Formación

• Extensive experience in regulatory affairs, especially in CMC and quality.
• Strong project leadership and management knowledge required.

Responsabilidades

• Lead projects ensuring successful planning and execution.
• Develop submission strategies for CMC activities and maintain client communication.

Conocimientos

Regulatory Affairs

Project Management

CMC Knowledge

Technical Writing

Networking Skills

Team Spirit

Business Acumen

Educación

University-level education in Life Sciences

Herramientas

Word

PowerPoint

Excel

Veeva Vault

Descripción del empleo

Food Preparation Worker

When our values align, there's no limit to what we can achieve.

Parexel, a leading Clinical Research Organization (CRO), is seeking a highly qualified Principal Regulatory Affairs Consultant (Associate Director level) with expertise in Chemistry, Manufacturing, and Controls (CMC) for small molecule. The ideal candidate will possess strong regulatory affairs experience, project management skills, and in-depth knowledge of post-approval CMC activities. As a recognized professional in your field of expertise, you will utilize your rainmaking skills and extensive knowledge of our consulting models and methodologies to deliver exceptional consulting services to our clients. This is a unique opportunity to showcase your technical skills, specialist knowledge, and mentorship abilities.

This role can be home or office based in various European locations.

Key Responsibilities :

• Serve as a Project Leader, providing overall project leadership and ensuring the project's successful planning and set-up.
• Act as the main client contact, maintaining accurate project reporting and delivering to meet client expectations.
• Develop and implement submission strategies and plans for post-approval CMC activities, including variations, renewals, market expansions, and annual reports.
• Assess change controls and provide regulatory assessments of quality changes in production and quality control.
• Review study reports from the quality control and production departments to ensure compliance with regulatory requirements.
• Coordinate submission preparation with various departments, including manufacturing, supply chain, quality control and quality assurance, and other regulatory departments and local companies.
• Write and review submission content to ensure alignment with regulatory requirements, specifically related to variations and questions from health authorities.
• Collaborate within a team environment to deliver project requirements. Prioritize workloads, both for yourself and the project team, to achieve project scope and objectives.
• Deliver engaging presentations at seminars and industry group meetings. Author articles for industry publications, demonstrating expertise and showcasing Parexel's capabilities.
• Identify, escalate, and mitigate risks associated with regulatory procedures and activities.
• Mentor and coach more junior members of the team.
• Collaborate with Account Management to prospect and leverage new business opportunities.
• Effectively communicate Parexel's service offerings, demonstrating our capability to support client needs.

Experience and Skills Required :

• University-level education in Life Sciences or equivalent by experience.
• Extensive experience in regulatory affairs, particularly related to technical / CMC / quality, within the pharmaceutical industry.
• Strong understanding of CMC and post-approval regulatory requirements.
• Experience in writing CMC (technical) sections of regulatory documents such as registration files or variations.
• Knowledge of small molecule processes.
• Proficient account planning and support abilities.
• Networking skills to expand professional connections.
• Team spirit, flexibility, accountability, and organizational skills.
• Strong project leadership and management knowledge.
• Strong business acumen for analysis and decision-making.
• Self-confidence and control in professional engagements.
• Proficiency in Word, PowerPoint, Excel, and experience with Veeva Vault is valued.