Sr. Manager/Associate Director, Regulatory Affairs

Job Description

Our client is seeking a Senior Manager/Associate Director of Regulatory. The position will be responsible for coordinating and ensuring quality regulatory submissions for the company. This is an opportunity for an experienced individual to join a growing specialty pharmaceutical company and work directly with senior management.

The successful candidate will:

• Lead and manage a team of Regulatory Affairs professionals.
• Coordinate and review all regulatory submissions of the company including ANDAs and 505(b)(2) NDAs, as needed.
• Develop and implement regulatory strategies and filings throughout each product’s lifecycle.
• Manage regulatory risks and ensure compliance with all applicable regulations.
• Ensure regulatory and cross-functional project strategies and submission timelines are in alignment for successful filing and timely approval.
• Actively monitor changes in applicable regulatory requirements and industry trends, and proactively identify and propose solutions for potential regulatory challenges.
• Maintain drug product labeling components for all commercial products.
• Author and review departmental SOPs, as well as any other additional SOPs that may impact regulatory affairs.

Qualifications:

• Bachelor’s degree in a scientific or technical field (e.g., chemistry, biology, pharmaceutics, etc.)
• 7+ years of work experience in US FDA regulated pharmaceutical development and manufacturing, including making submissions in eCTD format.
• A degree in regulatory affairs is preferred.
• Strong background in CMC documentation preferred.
• Must demonstrate strong leadership qualities: strategic thinking, decision making, problem solving, communication skills, attention to detail, project management, team building and development, professional integrity, influence and negotiating skills, adaptability and flexibility, and stakeholder management.
• Excellent organizational and time management.
• Exceptional communication and interpersonal skills across all levels of the Company.
• Self-starter who can be effective with minimal supervision.
• Excellent writing and communication skills consistent with the ability to prepare concise, timely, and accurate reports/presentations.
• Previous experience in managing personnel is a plus.