Description
JOB SUMMARY:Contribute to the development of, and lead the implementation of, regulatory strategies that result in the execution of regulatory plans for meeting information, INDs, and CTDs for biosimilar products for submission to global regulatory authorities. Ensure that Amgen acquires and maintains all the required approvals in order to support clinical trials for investigational products as well as approved products. Ensure timely compliance with all regulatory requirements to support the development and approval of biosimilar products.
KEY ACTIVITIES:
- With minimal supervision, develop and manage regulatory submissions (e.g. clinical trial and marketing applications) for products within Amgen's biosimilars portfolio in compliance with global filing plans and local regulatory requirements.
- Lead development of regional regulatory documents and meetings in accordance with the biosimilars regulatory strategy
- Implement product-related regulatory strategies, Regulatory Affairs processes and activity planning in accordance with national legislation and regulatory requirements.
- Provide regulatory guidance on regional regulatory mechanisms to optimize product development
- Contribute to the development of regional product labels for biosimilars by collaborating with the Labelling Working Group to define commercial objectives in the context of available and expected scientific data, regulatory guidance and precedent.
- Manage regional label negotiation activities
- Co-ordinates company responses to requests from regulatory authorities, e.g Response to Questions (RTQs)
- Communicate regulatory strategies as appropriate such that expectations are understood.
- Estimate the likelihood of regulatory success based on proposed strategies and discuss with the regulatory team and cross-function leads
- Ensure compliance with internal company requirements
- Represent the Biosimilars Regulatory Affairs Team to outside departments and product teams
SKILLS AND EXPERIENCE:
- BS / MS in a Scientific Field of Study
- 7+ years of related experience in the pharmaceutical/biotechnology or medical device industry
- 5+ years experience in Regulatory Affairs
- Experience in the development of CTDs for biologics
- Understanding of the regional regulatory procedures for CTAs, marketing applications, post approval changes, extensions and renewals
- Understanding of drug development
- Comprehensive understanding of regulatory activities, touch points and how they affect projects and processes
- Experience in working with policies, procedures and SOPs
To find out more about Real please visit www.realstaffing.com