Senior Regulatory Affairs Manager
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Job Location:
Monthly Salary:
Posted on:
10 hours ago
Vacancies:
1 Vacancy
Job Summary
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Job Description
About Takeda
At Takeda we are transforming patient care through the development of novel specialty pharmaceuticals and best in class patient support programs. Takeda is a patient-focused company that will inspire and empower you to grow through life-changing work.
Certified as a Global Top Employer Takeda offers stimulating careers encourages innovation and strives for excellence in everything we do. We foster a values-based collaborative workplace in which our teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world. As we continue growing we know that behind our greatest achievements there is an engaged team of curious learners.
About the Role
As the Senior Regulatory Affairs Manager you will lead the development and execution of innovative regulatory strategies for both pipeline and in-market products across Australia and New Zealand. Based in Sydney Australia this role is pivotal in ensuring regulatory compliance enabling successful product launches and shaping regulatory policy in alignment with global and regional objectives. You will also champion digital transformation within the regulatory function to enhance operational efficiency and collaboration.
What you will do:
- Develop and implement regulatory strategies for product registrations and submissions.
- Manage submissions through facilitated pathways to accelerate approvals.
- Liaise with TGA Medsafe and other authorities for submissions and negotiations.
- Prepare and submit regulatory dossiers and monitor regulatory impacts.
- Provide strategic input to cross-functional teams and drive digital innovation.
- Represent Takeda in external forums and mentor regulatory team members.
What were seeking in you:
- Degree in Life Sciences Pharmacy or related field.
- 8-10 years of Regulatory Affairs experience in Australia/New Zealand.
- Leadership and people management experience.
- Proficiency in digital tools and platforms like Veeva Vault and Power BI.
- Excellent communication and strategic thinking skills.
What awaits you:
- Market-leading benefits that make a difference to individuals families and carers during each stage of your career.
- Rewarding career and development opportunities tailored to your aspirations.
- Flexible leave options that help you personalize your work experience.
- Comprehensive wellbeing program supporting your social financial mental and physical wellbeing.
We are dedicated to fostering a diverse and inclusive workplace creating an environment where everyone can contribute and reach their full potential. We aim for all employees to feel equally valued supported and celebrated. Your unique attributessuch as culture national origin gender gender identity sexual orientation disability and agetruly enrich our team reflecting the diversity of our wider community. We welcome your application even if you dont have all of the required experience and encourage you to email us if we can provide any reasonable accommodations to enable you to participate in this recruitment process.
Locations
Sydney AustraliaWorker Type
EmployeeWorker Sub-Type
RegularTime Type
Full timeRequired Experience:
Manager
Key Skills
- Proofreading
- Adobe Acrobat
- FDA Regulations
- Manufacturing & Controls
- Biotechnology
- Clinical Trials
- Research & Development
- GLP
- cGMP
- Product Development
- Chemistry
- Writing Skills
About Company
Takeda is a patient-focused, R&D-driven global biopharmaceutical company committed to bringing Better Health and a Brighter Future.
