Regulatory Affairs Manager
You will play a crucial role in helping people live more fully at all stages of their lives at Abbott, a global healthcare leader with a portfolio of life-changing technologies spanning the spectrum of healthcare.
About Us
For over 135 years, Abbott has been helping people reach their potential — because better health allows people and communities to achieve more.
Key Responsibilities:
* Manage teams within the Regulatory Affairs Sub-Function, focusing on policy and strategy implementation and control.
* Oversee the strategy implementation and operations for directing development of product registration submission, progress reports, supplements, amendments, or periodic experience reports.
* Interact with regulatory agencies to expedite approval of pending registration.
* Serve as regulatory liaison throughout product lifecycle.
* Participate in product plan development and implementation, regulatory strategy, risk management, chemistry manufacturing control (CMC).
* Ensure timely approval of new drugs, biologics or medical devices and continued approval of marketed products.
* Serve as regulatory representative to marketing, research teams and regulatory agencies.
* Advise development and/or marketing teams on manufacturing changes, line extensions, technical labeling, appropriate regulations and interpretations.
Requirements:
* Manufacturing operations and manufacturing change experience.
* People management experience.
* Experience resolving issues regarding nonconformance.
* Strong attention to detail.
* Solid communication skills and ability to communicate at all levels.
* Experience with EU and US regulatory bodies.
* Strong organisational skills.
Qualifications and Experience:
* Minimum Level 8 Degree in Engineering or Science or related discipline.
* Minimum of 5 years of experience in a similar position and experience with EU Regulatory bodies in regards to applications and submissions or equivalent international experience.
About Us
Abbott is an equal opportunities employer.