Regulatory Affairs Director
3 days ago
Job Overview
We are seeking a seasoned Regulatory Professional to lead our Pharmaceutical Regulatory Consulting team in Australia. This role offers a unique opportunity to work with a diverse range of clients, primarily in the pharmaceutical and healthcare sectors.
Your Role
In this position, you will be responsible for maximizing client commercial success by ensuring appropriate licensing, marketing, and regulatory compliance of their products. You will advise, support, and manage regulatory submissions and approvals for products, including liaising with clients, regulatory teams, and third-party subject matter experts.
Key Responsibilities
- Lead a team of highly skilled Regulatory Consultants, providing guidance and oversight to ensure successful project delivery.
- Develop and implement strategies to maintain and improve regulatory compliance, ensuring timely and cost-effective product approvals.
- Liaise proactively with global, regional, and local colleagues to ensure seamless collaboration and information sharing.
- Collaborate with clients to understand their business needs and objectives, providing tailored solutions to address their regulatory challenges.
- Stay up-to-date with evolving regulatory requirements, adapting our approach to meet the changing needs of the industry.
Your Profile
To succeed in this role, you will require:
- A minimum of 10 years' experience working in regulatory affairs, either in industry or a consulting setting, preferably in prescription products.
- Demonstrated expertise in the Australian regulatory environment, with a strong track record of regulatory work spanning the entire product lifecycle.
- Experience leading regulatory assessments for early pipeline products and new technologies.
- Proven leadership skills, with the ability to achieve results through people and develop a positive team culture.
- Exceptional communication and stakeholder management skills, with the ability to effectively collaborate with cross-functional teams.
What We Offer
By joining PharmaLex Australia, you will become part of a team renowned for our expertise in pharmaceutical regulation. Our collaborative environment encourages knowledge sharing and professional growth, with opportunities to develop your skills and advance your career.
Location
The ideal candidate will be based in Sydney, NSW, Australia; however, we may consider Melbourne, Canberra, or Brisbane locations. Flexible working options, such as varying start and finish times, are available to support work-life balance.
Salary
We offer a competitive salary package, estimated at AU$120,000 - AU$150,000 per annum, depending on experience, plus benefits and bonuses.
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