Description
Global pharmaceutical company is currently looking for experience regulatory affairs manager toprovide scientific expertise to CMC writing and submission process for global projects.
This is a permanent opportunity, which offers further growth and development and opens up interesting pipeline of products to work on.
Responsibilities:
Providing regulatory CMC support of biological /small molecules products throughout the Life-Cycle
Define strategy, planning and preparation of regional specific CMC submission documentation for assigned geographical regions and contribute to the preparation of global submission documentation to deliver timely approvals to meet business needs
Leading and/or provide regulatory CMC input to all Health Authorities (HA) interactions on CMC matters in assigned regions
Developing and implementing the regional CMC regulatory strategy and submission plans for assigned projects/products to deliver timely approvals to meet business needs in regions assigned, and in line with the global regulatory strategy.
writing regional and global CMC documentation for submissions in line with agreed global regulatory strategy, and within agreed timelines
Provide strategic planning expertise relating to all global artwork implementation into production
Ensuring effective communication of CMC regulatory strategy, risks, and overall plan for assigned regions to GRA Practice Teams, TSO Practice Teams and PVUs
Experience and skills:
Life sciences University degree in a relevant life sciences or business related discipline
5-8 years relevant experience in the pharmaceutical industry or a regulatory authority CMC review capacity, including of experience in Regulatory Affairs CMC
Proven track record of successful authoring and contribution to delivering CMC sections of marketing authorisations for new biological and/or chemical entities
Broad background of registration experience gained from working in the pharmaceutical industry or a regulatory authority in one of the ICH regions on development and post approval products
Extensive experience of direct communication and negotiation with regulatory agencies on CMC matters
Extensive active participation in regulatory agency meetings on CMC matters
Knowledge of GMP requirements and standard systems (e.g. change management systems and tools)
Demonstrated competence in contributing on cross-functional teams and operating within a matrix organisational structure
Michael Bailey International is acting as an Employment Agency in relation to this vacancy.