Junior GPRM/Regcmc Manager (m/f)

REFERENZNUMMER:

364647/29

IHRE AUFGABEN:

-Author high-quality CMC documentation for health authority (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 participate as a member of the global 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 (Drug Reg Affairs Global Regulatory Compliance System) support, annual and product renewal writing, coordination/collection/storage of source documentation needed for direct submission to HAs, other database entry activities (specialised department functions)

IHRE QUALIFIKATIONEN:

-Degree in science (e.g. chemistry, pharmacy, biochemistry, biotechnology, biology) or equivalent
-Fluency in English (oral and written) and solid German language skills (oral)
-Regulatory experience preferred and/or experience in drug/biopharmaceuticals
-Working knowledge of chemistry/biotechnology, analytics or pharmaceutical technology
-Knowledge of the drug development process is beneficial
-Ability to critically evaluate data from a broad range of scientific disciplines
-Knowledge/experience of/in 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, organisational and interpersonal skills
-Reasonable approach to risk assessment.
-Excellent written/spoken communication and negotiation skills as well as knowledge of computer literacy

WEITERE QUALIFIKATIONEN:

Regulatory affairs manager