Senior Manager Regulatory CMC (m/f/d)

For our HELM Pharmaceuticals GmbH, we are seeking an enthusiastic and highly motivated professional to take on a key role in our interdisciplinary project team as (Senior) Manager Regulatory CMC (m/f/d). 

Your tasks:

• In this position, you will take full ownership of the regulatory responsibility for assigned projects across all phases with a focus on EU and US markets.
• Additionally, you will be the first point of contact for all quality and regulatory issues and will take on the communication and negotiation with our various internal and external partners such as national competent authorities, contract institutions, consultants or clients.
• In more detail, this means you will take over assigned projects from preparing the initial registration documents, particularly on quality (CMC) to coordinating and processing deficiency letters.
• In doing so, you will actively contribute to the project-specific development strategy. You will assess data and market exclusivity and develop the initial approval strategy, while also evaluating territory specific regulatory requirements and project demands.
• Furthermore, you are responsible for the dossier compilation (Module 2- 5) including guidance and review of dossiers from external partners.
• Moreover, you will develop solution proposals on topics of pharmaceutical quality and will act as a general interface between clinical development and licensing.
• Here, you are also responsible for evaluating the regulatory documentation on pharmaceutical quality within the scope of regulatory dossier purchases and in-licensing (Due Diligence). In addition, you ensure the adaptation of the marketing authorization documentation on the current state of national and international Regulatory Guidances.
• Participating and assisting with authority guidance requests (e.g. Scientific Advice Procedures, Controlled Correspondence etc.) complete your area of responsibility.

Your profile:

• You hold a completed master degree in natural science (Chemistry, Biology, Pharmaceutics) or hold an equivalent education.
• You can bring at least 5 years of professional experience in the field of regulatory affairs for drug products for European and national marketing authorisations.
• Moreover you possess of sound knowledge in the field of pharmaceutical technology & chemistry as well as further pharmaceutical international standards.
• Furthermore, you are highly familiar with documentation, communication and information management.
• Your excellent analytical, organizational, and strong communication skills make you an outstanding team player and provide you with problem-solving and conflict management competencies.
• Common IT applications such as Microsoft Office 365 are known to you.
• Fluent verbal and written communications skills in the English language complete your profile.