VP Regulatory Affairs

VP / Senior Vice President of Regulatory Affairs

Barrington James are proud to be working on a unique opportunity to join an exciting company with a fantastic pipeline of products, soon to go commercial with their first approved product.

My client, a small growing pharmaceutical company focusing in Oncology are looking to add an SVP Reg Affairs (with some strong CMC) to join their team working closely with the Chief Medical Officer.

This role will be working with the executive team and with the cross-functional departments.

Our client is now truly global, offices based in the US and APAC region (Australia office) and they want to be a leader in their unique space in the oncology role.

They are working on submittals and looking to have an approval late to early next year so this will be a key role for the business.

If you are like being part of a small company culture where you can play a pivotal role, then this is the role to not miss.

Key Activities

• Develop a portfolio-wide regulatory strategy, dove-tailed with Clinical, Manufacturing and Quality with deliverables, success criteria and implementation timeline

• Proactively identify regulatory risks, bring awareness to potential safety and compliance issues and provide creative solutions and strategies to overcome development hurdles, including risk mitigation

• Accountable for maintenance of existing product portfolio and for life cycle management to ensure alignment with corporate objectives

• Oversight for authoring review and approval, as necessary, internal regulatory documentation to ensure conformance with regulations and existing regulatory approvals, including package inserts and labels creation for clinical trials and/or any other use as a medication

• Monitor global regulatory guidelines and anticipate trends that impact of global regulatory environments on the development plan(s) and adopt regulatory risk mitigation strategies in a timely manner

• Partner and work very closely with Nonclinical, CMC, Quality and Clinical to align on strategy and content for submission

Ideal Candidate

• 15+ Years in Pharmaceutical/Biotech Industry
• A track record of approved products from beginning to end (CTA’s, MAA, IND to NDA/BLA)
• Background working with Oncology products
• Understanding of regulatory framework and working on submissions / approvals
• Experience working in other countries is a bonus

For more information, please send your resume to Ryan Banton at rbanton@barringtonjames.com and call me at 646 415 8221

Interviews will be starting 30^th August onwards