ASSOCIATE / ASSISTANT MANAGER - REGULATORY AFFAIRS @ ABBOTT

ASSOCIATE / ASSISTANT MANAGER - REGULATORY AFFAIRS @ ABBOTT

An opportunity to work within the CMC Regulatory function of an established fast-moving and ambitious multinational pharmaceutical company supporting a broad range of products including medicines, medical devices and foods supplements across multiple therapeutic areas. 

The right candidate will have at least 8+ years of experience within Regulatory Affairs and will be able to demonstrate strong technical Chemistry Manufacturing and Controls skills. A pharmaceutical development or production background is desirable. The position encompasses full life-cycle management activities; therefore, experience of supporting pre-approval product development and post-approval licence maintenance activities is essential. The company operates in multiple geographies and so experience in at least two of the following regions is a pre-requisite: Middle East and Africa; Russia and CIS; South East Asia and Greater China; Latin America.

The role involves, but is not limited to, the following activities:

·         Managing multiple activities according to agreed timelines and deliverables

·         Acting as the CMC subject matter expert in cross-functional project teams

·         Evaluating, interpreting, simplifying and communicating complex situations and data

·         Evaluating and interpreting legislation and its impact on the business

·         Generating innovative and robust regulatory strategies

·         Identifying and evaluating risks and providing mitigation plans

·         Providing mentoring support and guidance to more junior colleagues

·         Writing and compiling high-quality right-first-time submission-ready CMC documentation

·         Liaising with colleagues across multiple time zones

Candidates should also demonstrate the following attributes:

·         Measured decision making and risk taking

·         Excellent written and verbal communication skills

·         Strategic, creative and lateral thinking and problem solving

·         Enterprise thinking (seeing the big picture)

·         Ability to build and maintain relationships and credibility with peers and partners

·         Willingness to develop self and others

·         Attention to detail

·         An understanding and awareness of and respect for cultural differences

Ability to work autonomously where necessary and to self-manage time and workload

CLICK HERE TO APPLY

GET UDYOG ADDA UPDATES EVERY TIME AND SHARE UPDATES WITH JOB SEEKERS

CLICK HERE