Senior Director- Regulatory CMC- Drug/ Device

Radius Health • Chesterbrook, PA

303d • $243,000 - $280,000 • Remote

About The Position

Radius Health is a global biopharmaceutical company focused on bone health and osteoporosis. Our team works collaboratively and relentlessly to advance our therapies with the goal of improving the lives of patients, their families, and their caregivers. We are currently recruiting for a Senior Director, Regulatory CMC-Drug/Device. The incumbent will be responsible for regulatory leadership, preparation and support of US BLA and NDA regulatory submissions, and ensuring compliance to all applicable regulations and standards, with focus on CMC and with specific expertise in the device component of submissions and on drug/device combination product requirements. This is a key leadership role for both the regulatory and technical teams. This is a remote position, and the ideal candidate will be located in Northeast US.

Requirements

• Minimum of BS in life sciences, engineering, or equivalent required.
• RAC certification and/or other regulatory certification is a plus.
• 10+ years in the pharmaceutical industry, including drug/device combination product development and commercialization experience.
• Experience with regulatory requirements and submissions for companion diagnostics and medical devices.
• Experience in developing and submitting successful BLAs/NDA submissions with a thorough understanding of the drug development process, FDA regulations and ICH guidelines, with demonstrated expertise in drug/device combination products.
• Proactively advocates working together in the spirit of openness, honesty, and transparency that encourages collaboration, respectful interactions, and trust.
• Previous experience in leading regulatory teams.

Responsibilities

• Prepares and manages CMC Regulatory content for submissions in all applicable regions, ensuring high quality and timely submissions.
• Submissions may include BLAs, MAAs / NDAs - Module 3 and QOS content, supplemental submissions, and responses to health authority questions, in support of drug product or drug/device combination product development or commercialization.
• Supported activities may include companion diagnostic development, DP and/or drug/device combination product development, validation and commercialization, Design Control strategy and documentation, and Human Factors validation testing.
• CMC Regulatory and Combination Product Subject Matter Expert to Project teams and/or CMC sub-teams.
• Leads regulatory strategy for all activities with Regulatory impact for assigned projects, creating and maintaining CMC Regulatory strategy documents.
• Maintains expert knowledge in US and international pharmaceutical and combination product regulations and provides proactive regulatory intelligence, particularly in quickly changing and/or highly competitive areas, in all relevant territories (e.g. US, EU, JP, ICH), with a particular focus on device regulations.
• Key contact for Radius' drug delivery/device partners.
• Accomplishes department objectives by managing and leading team members.
• Develops and maintains team members by effectively recruiting, selecting, orienting, and training employees.
• Works with team members to develop growth opportunities within the organization.
• Continuously evaluates team performance and provides coaching to build skills and knowledge.

Benefits

• Medical, dental and vision benefits.
• Parental leave.
• 401K match.
• Generous time off plan including two company shutdowns; the week of July 4th and the last week in December.
• Competitive salary range of $243,000 - $280,000.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Industry: Merchant Wholesalers, Nondurable Goods
• Education Level: Bachelor's degree