12 Month Contract - Regulatory Affairs Manager - Senior Regulatory Lead China
As the Senior Regulatory Lead for China, you will be responsible for driving development and implementation of regulatory strategy for China for development products and new product registrations.
An integral member of regulatory project teams representing the China for development and marketed products
You will be working with global clinical development and R&D teams to prepare regulatory documentation to support regulatory engagement (pre-IND/pre-NDA) and NDA submissions in China, with a focus on briefing books and Module 2 documentation.
As the Senior Regulatory Lead, you will attend global regulatory, cross-functional R&D and asset level business meetings to provide strategic direction and scientific rationale for regulatory activities required to support clinical trials and marketing applications in China.
Providing oversight of local operational activities required to make regulatory applications in China, via CRO and company affiliate. Steer preparation and review of submission dossier.
Maintain close collaboration and partnership with China/regional business colleagues across levels, up to President of APAC, in addition to local medical and clinical operations colleagues.
To be considered for the role of Senior Regulatory Lead (China), you will:
Have the ability to work both independently with minimal direction and within project teams, committees, etc. to attain group goals.
Demonstrate excellent, succinct written and verbal communication skills.
Demonstrate strong organizational skills, including the ability to prioritize personal and junior team member's workload.
Have strong and demonstrable interpersonal skills and the ability to deal effectively with a variety of personnel including medical, scientific, and supply chain colleagues.
A crucial cross-cultural awareness and capabilities.The ideal candidate for this role will have previously lead or participated in major agency meetings (i.e. EU/US/Japan/China/Brazil), including material and team preparation.
Ability to thrive in an environment of respectful but challenging debate in order to arrive at the optimal cross-functional strategy.
Confident to identify and acknowledge when management support is required to prioritize or drive activities to a resolution.
The salary for this contract is dependant on experince and relevent skills.
Randstad CPE values diversity and promotes equality. No terminology in this advert is intended to discriminate against any of the protected characteristics that fall under the Equality Act 2010. We encourage and welcome applications from all sections of society and are more than happy to discuss reasonable adjustments and/or additional arrangements as required to support your application.
Candidates must be eligible to live and work in the UK.
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