Reg CMC Associate Manager (m/f)

REFERENZNUMMER:

352123/11

IHRE AUFGABEN:

-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 requirements in all global regions as well as for new technical trends
-Actively contribute to the regulatory strategy, identifying the critical issues and lessons learned as a member of the global team
-Establish and maintain sound working relationships with partners and customers
-Assume activities in support of the general department such as DRAGON support, annual and product renewal writing, coordination/collection/storage of source documentation needed for direct submission to HAs, other database entry activities (specialized department functions)

IHRE QUALIFIKATIONEN:

-(Advanced) degree in Science (e.g. Pharmacy, Biochemistry, Biotechnology, Biology) or equivalent
-Fluent English required (oral and written), good skills in site (local) language desired (oral)
-Regulatory experience preferred, and/or experience in drug/biopharmaceuticals
-Working knowledge of biotechnology, analytics or pharmaceutical technology
-Knowledge of the drug development process desirable
-Knowledge/experience of regulations, guidelines for NCEs and product life cycle maintenance desirable
-Effective planning, organizational and interpersonal skills
-Reasonable approach to risk assessment

WEITERE QUALIFIKATIONEN:

Regulatory affairs manager