BrightOwl Loader Loading

Regulatory Affairs Manager - Australia  

Lilly (company)

Posted on : 28 May 2017

Project Description

Regulatory Affairs Manager
New South Wales
Lilly is a top 10 global pharmaceutical company, dedicated to creating medicines that help improve peoples' quality of life for more than 135 years. At the heart of Lilly's operations are its core values – excellence, integrity and respect for people and these are reflected in business practices that include strong governance principles, the ethical development of medicines, transparency and ethical product promotion.

The role of the Regulatory Affairs Manager is to provide:

eadership of the Regulatory Affairs Department to ensure the success of first time registration of new chemical entities, line extensions and new indications in alignment with the affiliate business plan, while maintaining compliance for all marketed products with local and corporate regulatory requirements.

It is also responsible for local management of personnel involved in pharmacovigilance activities and responsible for pharmacovigilance obligations across the affiliate.

The role is expected to f
oster an environment of operational excellence through deep regulatory expertise, managing and developing direct reports, excellent collaborating with new product launch teams, external focus and achieving or exceeding all local and corporate business objectives.

It is also expected to foster and cultivate excellent relationships with the local regulators, Therapeutic Goods Administration (Australia) and Medsafe (New Zealand).



 Tertiary Science Degree or Pharmacy Degree is desirable

Most Critical Skills & Attributes:

 Demonstrated project management and time management skills.

Strong interpersonal skills and strong ability to be flexible in varying environments and with multiple customer

Demonstrated high-level end-user computer skills (e.g., word processing, tables and graphics, spread sheets,
presentation and templates).

 Strong Learning agility

 Proven Resilience and Optimism

 Ability to lead through change

 Effective communication

 Effective Planning and Decision Making

 High Emotional Intelligence

Prior Knowledge or Experience:

Five or more years’ experience in people leadership and managing Regulatory Teams in pharmaceutical industry in

 Vendor management experience desirable

Familiarity/experience with the Medical affairs department such as Medical Information, Drug Safety and Product
Quality Complaints preferred