Position Summary:

ultradedicated – Your biggest challenges yield rare possibilities

As our Senior Manager, Regulatory Affairs CMC EMEA, you drive optimal EMEA regulatory CMC strategies for assigned products during product development and manage EMEA regulatory CMC objectives in alignment with department and corporate goals. You work closely with cross functional project teams to support product development, global clinical trials and marketing approvals, while ensuring that EMEA regulatory strategies are implemented and EMEA requirements for the assigned projects are achieved. You will initially be focusing on some of Ultragenyx marketed/pipeline programs and the respective regulatory strategies including their execution. You possess appropriate knowledge of EMEA rules, regulations, and guidance governing drugs, biologics and ATMPs (e.g. gene therapy) in late phases of development and post-marketing.

Work Model:

Flex: This role will typically require onsite work 2-3 days each week, or more depending on business needs. In many locations, the business will set certain days each week that Flex employees are required to be onsite. This is a Fixed Term Contract for an initial period of 12 months.

Responsibilities:

1. Lead the development of regulatory strategies and interaction with Health Authorities with a focus on the EU and Middle East (EMEA) region; provide strategic input and regulatory advice to the project teams on clinical programs and life cycle management of marketed products.
2. As a Regional Regulatory CMC representative to assigned program teams, collaborate with project teams to implement Ultragenyx regulatory strategies for the EMEA region. Ensure and/or enhance regulatory compliance with respect to filing requirements for assigned compounds throughout development and the commercial life cycle. Proactively identify project CMC issues and implement appropriate regulatory strategies to mitigate risks.
3. Manage or support the preparation and submission of regulatory applications (CTA, MAA, etc.) and any post-marketing commitments and maintenance. Develop and/or review regulatory documents to ensure that all submissions are of high quality. Communicate with internal and external partners to obtain required supporting documents and data for compilation of regulatory submissions in a timely manner that supports agreed upon project timelines.
4. Coordinate or support the task of drafting responses to CMC related questions from health authorities per established process.
5. Evaluate proposed manufacturing changes for regional impact to ongoing and existing dossiers and provide a regulatory assessment and a submission strategy for optimal implementation of changes.
6. Support the preparation and conduct of Agency meetings, including preparation and coordination of briefing packages.
7. Support the organization in maintaining a work environment focused on quality and that fosters learning, open communication, collaboration, integration, and teamwork.

Requirements:

1. BA/BS degree in life sciences in chemistry, molecular biology, or similar is required, an advanced degree is preferred.
2. More than 6 years of experience in Regulatory Affairs CMC in the pharmaceutical and/or biotechnology industry. Alternatively, 4 years Regulatory CMC experience combined with more than 4 years relevant pharmaceutical experience (e.g., Pharmaceutical Development, Analytical Development, Production, Quality Assurance or Quality Control).
3. Prior success filing of clinical trial applications, marketing applications, amendments, supplements, and variations for drugs and/or biologics within the EMEA region is required; global submission experience and/or knowledge of global regulations/requirements is a desired plus.
4. Thorough understanding of relevant drug development regulations and guidelines within the EMEA region is essential to support programs during development and commercial lifecycle. Proven ability to successfully interact with regulatory authorities.
5. Working knowledge in the rare disease space and the ability to deal with issues of critical importance, providing regulatory advice and making reasoned decisions on regulatory issues for which there may not be clear/specific regulatory guidance is privileged.
6. Understanding of scientific principles and regulatory CMC requirements relevant to all stages of pharmaceutical drug development and manufacturing, process validation, analytical operations, compliance, and documentation supported by a strong quality mindset.
7. Travel: approximate 5%
8. Fluent in English, Arabic is a plus

#LI-CT1, #LI-Hybrid