Regulatory Associate I

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 8 products in the market that are making a real impact on patient outcomes.

Job Summary:

The Regulatory Affairs Associate I is responsible for supporting Supernus efforts to bring safe and effective therapies to the market. This role is responsible for ensuring compliance with regulatory requirements by assisting in the preparation, submission, and maintenance of regulatory filings. This role works closely with senior regulatory professionals and cross-functional teams to contribute to the approval and lifecycle management of Supernus products.

Essential Duties & Responsibilities:

• Initiates and maintains departmental databases and filing systems for regulatory submissions and pertinent documents.
• Ensures compliance to the requirements of U.S. and foreign regulatory agencies.
• Assures procedures are in place to classify and maintain records.
• Interprets and enforces all documentation formatting, standards, policies, and operating procedure requirements.
• Coordinates regulatory workflow, provides regulatory support, and tracks regulatory timelines.
• Assists with tracking and coordinating submissions/activities to assure that timelines and commitments are met and that all regulations are being adhered to.
• Prepares standard documentation supporting regulatory filings and submissions to the Food and Drug Administration (FDA).
• Utilize and maintains electronic filing systems for auditable regulatory documents.
• Maintains effective high-profile communications and interactions with colleagues and collaborators.
• Track regulatory activity, maintain and updates databases, and ensures that records are complete and current.
• Other duties as assigned.

Non-Essential Duties & Responsibilities:

• May participate in project team discussions and related activities associated with clinical and post approval aspects of drug development.

Knowledge & Other Qualifications:

• Bachelor's degree in life sciences, pharmacy, chemistry, biology, or a related field.
• Minimum of 0+ years of direct experience. One year of experience in a regulatory environment, pharmaceutical development, or a related field is preferred.
• Knowledge of current Electronic Common Technical Document (eCTD) Standards, Good Manufacturing Practices (cGMPs), Good Clinical Practices (GCPs), and Good Laboratory Practices (GLPs) preferred.
• Experience publishing regulatory submissions using electronic submission software and proficiency in preparing documents that are compliant with electronic submission standards is preferred.
• Familiarity with regulations/guidelines governing development of pharmaceuticals.
• Detail oriented with good analytical skills.
• Strong organizational skills with attention to detail and accuracy.
• Excellent verbal and written communication skills in the English language.
• Ability to work well under pressure.
• Ability to handle multiple competing priorities.
• Computer literate with proficiency of Microsoft Office package including Word, Outlook, Excel, and Adobe PDF.
• Must be able to exercise initiative and sound judgment, and to prioritize ongoing projects.

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 $55,000 to $73,000. 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.

Supernus Pharmaceuticals is an Equal Opportunity / Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, protected veteran status, age or any other characteristic protected by law.