From removing the regular pain of fingersticks as people manage their diabetes to connecting patients to doctors with real-time information monitoring their hearts, from easing chronic pain and movement disorders to testing half the world’s blood donations to ensure a healthy supply, our purpose is to make the world a better place by bringing life-changing health technologies to the people who need them. That’s our commitment to helping you live your best life.
Position: Associate Regulatory Affairs
Description
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:
1. Managing multiple activities according to agreed timelines and deliverables
2. Acting as the CMC subject matter expert in cross-functional project teams
3. Evaluating, interpreting, simplifying and communicating complex situations and data
4. Evaluating and interpreting legislation and its impact on the business
5. Generating innovative and robust regulatory strategies
6. Identifying and evaluating risks and providing mitigation plans
7. Providing mentoring support and guidance to more junior colleagues
8. Writing and compiling high-quality right-first-time submission-ready CMC documentation
9. Liaising with colleagues across multiple time zones
Candidates should also demonstrate the following attributes:
1. Measured decision making and risk taking
2. Excellent written and verbal communication skills
3. Strategic, creative and lateral thinking and problem solving
4. Enterprise thinking (seeing the big picture)
5. Ability to build and maintain relationships and credibility with peers and partners
6. Willingness to develop self and others
7. Attention to detail
8. An understanding and awareness of and respect for cultural differences
9. Ability to work autonomously where necessary and to self-manage time and workload
