Associate Director, Regulatory Affairs – CMC

Orano • Plano, TX

104d • Onsite

About The Position

Orano Med has developed new processes for producing high-purity lead-212, a rare radioactive isotope. Lead-212 is currently at the heart of promising research projects in nuclear medicine to develop new treatments against cancer. The innovative approach, known as targeted alpha therapy (TAT), recognizes and destroys cancer cells while limiting the impact on nearby healthy cells.

The Associate Director, Regulatory Affairs – CMC will be responsible for leading the global regulatory CMC strategy for product development and registration, and for the preparation of CMC dossier in the expanding field of radiopharmaceuticals in the US and in EU.

This global role will join the regulatory team and will report directly to the Head of Regulatory Affairs. The person will work cross-functionally with the CMC team and the manufacturing sites to lead the regulatory CMC strategy and the preparation of regulatory CMC documentation and submissions in adherence to relevant regulatory requirements and company standards.

Requirements

• Bachelor’s degree in a scientific discipline. Advanced degree (MS, PharmD or PhD) is a plus.
• A minimum of 8 years Regulatory CMC experience and/or CMC technical writing experience in a pharmaceutical or biotechnology environment including injectables.
• Demonstrated hands-on experience in pharmaceutical development, registration in the US and/or EU, and interaction with health authorities.
• Demonstrated experience in preparing regulatory submissions, including IND/CTA, NDA/MAA, DMF/ASMF, briefing documents, and response to agency questions.
• Technical knowledge in small molecules with experience in translating to a regulatory document.
• Knowledge of relevant global CMC regulations and guidelines (ICH, US, EU)
• Experience within a GMP environment with a firm understanding of industry regulations and best practices
• Ability to understand and interpret complex scientific issues across multiple projects as it relates to regulatory requirements and strategy.
• Excellent verbal and written communication skills. Able to defend the regulatory CMC position while maintaining positive professional relationships
• Proactive, able to work independently and collaboratively in a fast-paced emerging field
• Analytical thinker with good problem-solving skills and the capacity to adapt to a field with relatively few guidelines available.
• Excellent planning and organization skills including the ability to support multiple projects.
• Proficiency with Microsoft Office.

Nice To Haves

• Knowledge of radiopharmaceuticals and innovative platforms is a plus.

Responsibilities

• Leads the development and preparation of global (US and EU) CMC-related submission documents for the pipeline of radiopharmaceutical products. This includes authoring, review and consolidation to deliver high-quality documents. Working in close collaboration with the CMC team (Manufacturing, Quality, R&D process), the regulatory CMC lead will collect technical data from relevant partners to write regulatory CMC documents and support the overall project goals.
• Develops robust global regulatory CMC strategies for the pipeline of radiopharmaceutical products. Identifies risks and proposes risk mitigation to enable successful regulatory submissions and approvals. Aligns within Regulatory Affairs to enable one regulatory voice.
• The regulatory submissions include but are not limited to the M3/CMC section of INDs/CTAs (IMPD-Q), DMF/ASMF, briefing documents, response to queries, Orphan Drug Applications, and annual reports.
• Manages regulatory CMC agency interactions and meetings.
• Meets current regulatory standards and achieves timely submissions, to enable approval on the first review cycle. Effectively interprets and applies regulatory CMC guidance. Provides recommendations and solutions to cross-functional teams and key stakeholders.
• Works with the Regulatory Operations vendor to coordinate publishing and submission for CMC dossiers (eCTD)
• Leads or contributes to the development of internal processes to improve the regulatory and CMC ways of working.
• Remains current on CMC regulatory intelligence.

Benefits

• Competitive compensation
• Health, Dental, and Vision insurance – with generous employer contributions
• 401(k) with employer matching and contribution amounts
• Life insurance and Short- and Long-Term Disability insurance provided by the company
• Generous Paid Time Off and holiday schedules
• Numerous Training and Development opportunities
• and more…

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Education Level: Associate degree