Senior Manager Regulatory Affairs CMC

Supernus Pharmaceuticals is an award-winning biopharmaceutical company with more than 30 years of experience in developing and commercializing products that treat central nervous system (CNS) diseases. At Supernus, we develop innovative products that help treat neurological and psychiatric conditions. We currently have 9 products in the market that are making a real impact on patient outcomes.

Job Summary:

The Senior Manager, CMC is responsible for managing the regulatory aspects of projects/products including the preparation and submission of correspondence and applications to regulatory agencies.

Essential Duties & Responsibilities:

• Identifies, obtains, compiles and reviews regulatory documents concerning CMC-related issues that are needed for FDA submissions including IND, NDA, NDA supplements and briefing packages for agency meetings
• Facilitates preparation of IND/NDA annual reports and keep other annual updates or reports current
• Review and assess the regulatory impact of routine proposed manufacturing related changes, non-conformance events and other GMP related documents; researches topics when requested by supervisor
• Work directly with the contract electronic publisher to get submissions published and submitted
• Tracks, documents and communicates progress of regulatory submissions and approvals
• Orders, tracks and process CMC-related regulatory submission documentation (e.g. certificates, declarations, sample requests and COAs)
• With appropriate supervision from senior management, interfaces cross-functionally with CMC stakeholders (e.g. manufacturing, supply chain and quality) in the context of major manufacturing initiatives
• Under supervision, evaluate and communicate impact of relevant regional regulations, guidance and current regulatory environment
• Other Duties as Assigned

Supervisory Responsibilities:

• Provides leadership and management in an effective manner consistent with Company Values towards defined Corporate Objectives
• Understands Company Policy and procedure to be able to guide direct reports appropriately

Knowledge & Other Qualifications:

• Relevant Ph.D. with minimum 3+ years or Master's/Bachelor's with minimum 6+ years relevant experience in pharmaceutical regulatory affairs
• Solid knowledge of eCTD Quality sections and regulatory submissions experience
• Excellent knowledge and understanding of FDA/ICH regulations and relevant guidance (CMC)
• Proficient in Microsoft Windows applications

Other Characteristics:

• Ability to work independently and as part of a team and maintain high ethical standards of integrity and quality
• Ability of having an innovative and dynamic approach to work
• A self-starter able to work independently but comfortable working in a team environment
• Ability to consistently exhibit Supernus Values in interactions with employees at all levels of the organization, vendors, customers and others
• Capable of performing other duties as assigned by Management
• Authorized to legally work in the United States without visa sponsorship

Physical Requirements/Work Environment/Travel Requirements:

• Sedentary work. Exerting up to 10 pounds of force occasionally and/or carrying objects. Sedentary work involves sitting most of the time
• The worker is required to have close visual acuity to perform an activity such as: preparing and analyzing data and figures; transcribing; viewing a computer screen, iPad, or other electronic device; and extensive reading
• The worker is not substantially exposed to adverse environmental conditions

Compensation:

At Supernus, we offer a competitive compensation package that reflects your experiences and contributions. The expected salary range for fully qualified candidates applying for this role is $135,000 to $155,000. This range is what the Company reasonably expects to offer for the position and is not reflective of the full compensation scale of the role. This range may be modified in the future. An individual's salary within the range is based on multiple factors, which may include and are not limited to education, relevant experience, knowledge, length of industry experience and organizational needs.

Base salary is one part of the overall compensation package, which includes the opportunity to participate in employee stock purchase programs and performance-based bonus programs.