Beschreibung
Daily tasks:Formulate, lead and drive global CMC regulatory strategy for development projects or marketed products with a focus on creativity and innovation, maximizing the business benefit balanced with regulatory compliance.
Proactively communicate CMC regulatory strategy, key issues throughout the life cycle in an adequate and timely manner to interdisciplinary project teams and to appropriate management level in regulatory, technical development and technical operations departments as appropriate.
Lead and implement all global CMC submission activities (planning, authoring, reviewing, coordination, submission) for assigned projects/products, while applying the global strategy into submissions. Make quality regulatory decisions, balancing risks and benefits.
identify the required documentation and any content, quality and/or timeliness issues for global submissions and negotiate the delivery of approved technical source documents in accordance with project timelines.
Author high-quality CMC documentation for HA submission, applying CMC global regulatory strategies, assuring technical congruency and regulatory compliance, meeting agreed upon timelines and e-publishing requirements.
Establish and maintain a single point of contact with FDA or country affiliates, RA regional and TA groups for all communication on development and marketed products. Establish and maintain sound working relationships with partners and customers.
Initiate and lead Health Authority interactions and negotiations as appropriate; setting objectives, preparing briefing books, coordinating and planning rehearsals and risk mitigation plans.
Lead and drive cross-functional CMC Health Authority Response Teams (HARTs) for as-signed development projects and/or marketed products, and prepare CMC responses, as appropriate.
Lead, prepare and communicate CMC risk management assessments , contingency plans on major submissions and escalate to management as appropriate.
Keep knowledge up to date with regard to regulatory guidelines and requirements in all global regions as well as for new technical trends.
Requirements:
Degree in Science (e.g. Chemistry, Pharmacy, Biochemistry, Biotechnology, Biology) or equivalent
Minimum 4 years of experience in regulatory affairs in drug/biopharmaceuticals
Working knowledge/experience in regulatory submission and approval processes for new chemical entities (NCE) and product life cycle management and proven practical knowledge of and ability to deal with complex CMC regulatory issues and requirements.
Proven track record of successfully working in interdisciplinary teams and planning, coordinating and leading activities simultaneously on multiple projects.
Regularly demonstrated active contributions to line functions or project teams, as well as ability to contribute to matrix teams with the necessary strategic thinking.
Demonstrated ability for strategic thinking, maintaining awareness of business impact.
Demonstrated ability for risk assessment and mitigation.
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.
Please send your CV
Michael Bailey International is acting as an Employment Business in relation to this vacancy.