Assoc Dir, CMC Regulatory Strategy

Role Summary

The Associate Director position, Regulatory Affairs Global CMC is responsible for establishing global regulatory CMC Strategies for commercial and development projects in line with the global regulatory strategy. The Associate Director will have a strategic role in driving CMC Regulatory Strategies across multi-disciplinary teams, including leading the preparation of regulatory CMC submissions.

Responsibilities

• Leads activities that include planning content, authoring where appropriate, reviewing and approval of Module 2 and 3 CTD sections of all regulatory submissions (INDs, IMPDs, CTAs, MAAs, NDAs, BLAs, meeting requests, and briefing documents), in support of Global Regulatory Team Objectives.
• Provide in-depth reviews of protocols, reports, presentations, and documents for CMC Development or Commercial product team, as required.
• May represent Reg-CMC at related regulatory agency interactions for team products, and manage the preparation and review of material for agency interactions.
• Provide timely updates of CMC Regulatory Strategy for the Global Regulatory Strategy document for assigned projects, as required and securing functional support.
• Lead the preparation and submission of responses to regulatory agencies are managed appropriately and in a timely fashion.
• Regularly interact with functional leaders, on matters concerning CMC regulatory strategy, including regulatory agency interactions to ensure functional alignment.
• Lead GRA-CMC or GRA projects / initiatives that significantly impact the business globally.
• Identify and lead continuous improvement opportunities for the GRA-CMC team and the broader GRA team.
• Ensure continued regulatory compliance of products though adherance to change control and Regulatory Information Management procedures, completing the regulatory impact assessment of changes and ensuring appropriate implementation planning is executed.
• Ensure compliance with company policies, procedures and training expectations.

Requirements

• Demonstrated understanding and strategic application of regulations and guidelines for drug lifecycle activities.
• Demonstrated knowledge of CMC regulatory and ability to generate clear, well-argued positions.
• Must have experience with electronic Common Technical Document CMC regulatory documents (MAA, BLA, variations, responses and CTAs/INDs).
• Demonstrated understanding of FDA, EMA and ICH guidelines.
• Exceptional interpersonal skills with the ability to work individually, within a multi-disciplinary team, as well as with external partners and regulators.
• Demonstrated ability to influence and impact their functional area and department practices.

Education

• BSc/BA with experience of regulatory CMC or related experience.
• Strong English language - written and verbal communication skills.