Commercial Eyes has a great opportunity for a Regulatory Services ManagerReporting to the Director, Regulatory Services, the Manager is responsible for the day to day operational management of the regulatory team and the assigned project portfolio within the Regulatory Services business unit.
To be successful in this role, you will have…
- A degree in science, pharmacy or a related discipline.
- A minimum of 10 years of experience in Australian and New Zealand regulatory affairs, preferably in a commercial environment.
- Ability to develop sound strategies to resolve complex regulatory problems.
- Good working relationships with relevant TGA staff and experience with TGA pre-submission meetings.
- Experience in the review, critical evaluation and presentation of clinical data.
- Good knowledge of TGA legislation, regulations, guidelines and working procedures.
- High level written and oral communication skills.
- Proven ability to manage projects.
- Experience or aptitude for mentoring and leadership
- Experience in staff management in a regulatory environment.
- Ability to deal with high level of confidentiality.
Key responsibilities include:
- Manage regulatory projects and staff to ensure optimum project outcomes.
- Ensure agreed financial and organisational targets are met.
- Undertake key account management and day-to-day liaison with clients as agreed with the Director, Regulatory Services.
- Undertake business development and assist the Director, Regulatory Services to develop business development and other growth strategies.
- External Representation of the business unit where possible
- Attract new talented regulatory professionals to join the business.
- To provide support to clients on the registration and listing of pharmaceuticals and medical devices in Australia and New Zealand.
- Provide strategic advice to clients regarding the Australian and New Zealand regulatory environment.
This role is a rewarding one that will offer a competitive salary to the right candidate and a rare opportunity to lead a dynamic and successful team. You will also have access to a flexible work environment, life-work balance and the opportunity to expand your professional network working with local and multinational pharmaceutical companies, as well as a range of other companies developing novel and cutting edge health technologies.
Becoming part of the CEPL team will also provide you with a strong sense of teamwork, job satisfaction and achievement whilst working in a well-known professional services organisation that recognises talent and expertise as one of its biggest assets.
For more information about this role, please visit our Seek ad.
Please contact Jeanette Lodge on 03 9251 0777 if you have queries about the role that have not been addressed in the job ad.