Director, US RA CMC Team Leader – Innovation, Global CMC Regulatory Affairs

Job not on LinkedIn

🕒 6 days ago

🇺🇸 United States – Remote

💵 $180k - $230k / year

⏰ Full Time

🟠 Senior

🚔 Compliance

👻 Ghost score 13%

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Dechra

WebsiteLinkedInAll Job Openings

1001 - 5000 employees

Founded 1997

💊 Pharmaceuticals

🏥 Healthcare

💰 IPO on 2000-08

Pharmaceuticals • Healthcare

Dechra is an international veterinary pharmaceuticals and related products business. The company develops, supplies and supports high‑quality medicines and allied products exclusively for veterinarians and veterinary professionals worldwide. Dechra emphasizes veterinary-focused services—providing clinical support, professional education through Dechra Academy, and global distribution and sustainability efforts—positioning itself as a partner to veterinary professionals to improve animal health and wellbeing.

📋 Description

• Lead the US Regulatory Affairs CMC team, setting priorities and supporting delivery of regulatory strategies and submissions • Provide strategic US CMC regulatory leadership across development and lifecycle activities • Oversee preparation, review and submission of CMC sections for US regulatory applications, amendments, supplements and responses to health authority questions • Partner with Global CMC Regulatory Affairs colleagues and cross-functional teams, including technical development, manufacturing, quality and supply • Advise project teams on US regulatory requirements, risks and opportunities • Build and advance innovation in CMC regulatory processes, tools and ways of working • Represent the organisation in interactions with US health authorities • Monitor changes in US CMC regulations and guidance and communicate relevant developments • Develop team capabilities through coaching, feedback and knowledge sharing • Support veterinary pharmaceuticals from development through lifecycle management, including technology transfers, site strategy, manufacturing changes, product/process improvements, and global CMC strategies for innovation and registration preparation

🎯 Requirements

• Extensive experience in CMC Regulatory Affairs, including substantial experience supporting US regulatory submissions and product lifecycle activities • Strong knowledge of US CMC regulations, guidance and health authority expectations • Experience leading, developing or mentoring regulatory professionals and coordinating complex, cross-functional work • Demonstrated ability to shape regulatory strategy and provide clear, risk-based advice on complex CMC matters • Experience managing submission planning, content review and responses to health authority questions • Interest in driving innovation and continuous improvement in regulatory processes and operations • Excellent written and verbal communication skills, with the ability to influence and collaborate across teams and levels of an organisation • Strong organisational skills and the ability to manage multiple priorities in a changing environment • Degree in Science (Biology, Biochemistry, Chemistry, Bioengineering, etc.), BS/MS/Ph.D with significant industry experience in CMC regulatory affairs and in CMC regulatory affairs innovation/product development • Regulatory exposure in global regions is required

🏖️ Benefits

• Competitive salary

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