Main characteristics
- Location
- Melbourne, Victoria
- Company
- Michael Page
- Salary
- AU$155,000 - AU$175,000 per year
- Employment type
- Permanent
- Category
- Executive Search
- Industry
- Healthcare / Pharmaceutical
Job summary
About Our ClientThe client is an up and coming pharma company expanding in Australia with a big global presence
Job Description
- Regulatory Strategy Development: Develop and implement regulatory strategies to support the development, registration, and commercialization of pharmaceutical products in compliance with local and international regulations.
- Regulatory Submissions: Prepare, review, and submit regulatory documents such as investigational new drug applications (INDs), new drug applications (NDAs), marketing authorization applications (MAAs), and variations to regulatory authorities.
- Communication with Regulatory Authorities: Serve as the primary point of contact for regulatory agencies, ensuring timely and accurate communication regarding product submissions, queries, and inspections.
- Regulatory Compliance: Stay updated on relevant regulations, guidelines, and industry trends to ensure compliance with changing requirements and mitigate regulatory risks.
- Cross-Functional Collaboration: Collaborate with internal departments such as research and development, clinical operations, quality assurance, and marketing to provide regulatory guidance and support throughout the product lifecycle.
- Regulatory Intelligence: Monitor regulatory changes and assess the potential impact on product development plans, providing recommendations to senior management as needed.
- Regulatory Training: Provide training and guidance to internal stakeholders on regulatory requirements, processes, and best practices.
- Quality Assurance Support: Support quality assurance activities, including the review and approval of quality documentation related to regulatory submissions
The Successful Applicant
Should be currently working with a pharma company in their regulatory department with experience in managing oncology, injectables , biosimilars products
Be open to be a part of a growing set up and lead from the front for company wide initiatives
What's on Offer
Its a leadership role and immense exposure and growth opportunity for a leading pharma generics brand
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