Regulatory Affairs CMC Associate Manager (m/f)

Description

• Author high-quality CMC documentation for HA submission, with support and guidance, applying agreed CMC global regulatory strategies, assuring technical congruency and regulatory compliance, meeting agreed upon timelines and e-publishing requirements throughout project lifecycle.
• Prepare CMC responses to health authority questions during development, registration and product lifecycle.
• Identify the required documentation for global submissions and negotiate the delivery of approved technical source documents in accordance with project timelines.
• Identify content, quality and/or timeliness issues with source documents, or any other potential authoring issues that may impact submission quality or timelines, as early as possible.
• Keep knowledge up to date with regard to regulatory guidelines and require-ments in all global regions as well as for new technical trends.
• Actively participate as a member of the global Regulatory Affairs CMC team by contributing to the regulatory strategy, identifying the critical issues and lessons learned.
• Establish and maintain sound working relationships with partners and customers.
• Assume activities in support of the general department such as DRAGON sup-port, annual and product renewal writing, coordination/collection/storage of source documentation needed for direct submission to HAs, other database en-try activities (specialized department functions).

• Degree in Science (e.g. Chemistry, Pharmacy, Biochemistry, Biotechnology, Biology) or equivalent
• Languages: Fluent English required (oral and written). Good skills in site (local) language desired (oral)
• Profound experience in regulatory preferred, and/or experience in drug/biopharmaceuticals
• Working knowledge of chemistry/biotechnology, analytics or pharmaceutical technology. Knowledge of the drug development pro-cess desirable. Ability to critically evaluate data from a broad range of scientific disciplines.
• Knowledge/experience of regulations, guidelines for NCEs and product life cycle maintenance desirable.
• Ability to work successfully with extended, multinational project teams and coordinate activities simultaneously on multiple projects under pressure of time and workload.
• Effective planning, organizational and interpersonal skills.
• Reasonable approach to risk assessment.
• Excellent written/spoken communication and negotiation skills.