Associate Director Regulatory Affairs Post Marketing

Supernus Pharmaceuticals; Rockville (MD); On-site; USD 140,000 - 175,000; Full time

Job summary

An established industry player is seeking an Associate Director of Post-Marketing to oversee regulatory activities for CNS products. This pivotal role involves ensuring compliance with regulations, managing advertising reviews, and supporting product lifecycle management. The ideal candidate will possess extensive experience in regulatory affairs, particularly within the pharmaceutical sector, and have a strong background in product labeling and FDA interactions. Join a team dedicated to improving patient outcomes through innovative therapies and enjoy a competitive compensation package that reflects your expertise and contributions.

Benefits

Employee stock purchase program

Performance-based bonus programs

Qualifications

• 5+ years in pharmaceutical regulatory affairs required.
• Experience with advertising and promotional materials review.
• Knowledge of FDA regulations desirable.

Responsibilities

• Manage post-marketing regulatory activities for products.
• Review promotional materials and labeling changes.
• Lead regulatory affairs activities and support marketing.

Skills

Regulatory Affairs

Advertising Review

Product Labeling

FDA Interface

Microsoft Office Suite

Education

Bachelor's Degree

Master's Degree

Ph.D. in relevant field

Job description

Description

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 Associate Director of Post-Marketing is responsible for providing management of a post-marketing regulatory activities, ensuring compliance with regulatory requirements, and supporting lifecycle management of Supernus products.

Essential Duties & Responsibilities:

• Primarily responsible for Regulatory Affairs activities involving marketed products. Specifically, this party is responsible for:


• Regulatory review of advertising and promotional materials for assigned products, submission of materials, and representing Regulatory Affairs on promotional review committee.


• Acts as primary source of contact for marketing departments for assigned products


• Assist in the creation of and implementation of changes to product labeling including:


• Package inserts and structured product label.


• Medication guides.


• Container labels.


• Core safety data sheets


• Maintaining Regulatory archive of product labeling


• May be asked to be a department representative on selected project teams for commercial products, for completion of post-marketing commitments


• May assist with interface with licensees regarding ex-US sales and promotion and labeling of commercial products


• May attend scientific sessions for regulatory affairs department.


• 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:

• Bachelor's degree required, Master's degree preferred.


• Relevant Ph.D. with minimum 5+ years or Master's/ Bachelor's with minimum 8+ years relevant experience in pharmaceutical regulatory affairs.


• Minimum of 5 years of experience (preferably recent) reviewing advertising and promotional materials required


• Experience with direct interface with FDA Office of Prescription Drug Promotion desirable


• Experience with creation and implementation of product labeling highly desirable


• Pharmacy/medical and or medical-legal background strongly preferred.


• Experience with neuroscience products desirable


• Experience with the Microsoft Office Suite.

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 $140,000 to $175,000. 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 employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, national origin, disability, protected veteran status, age or any other characteristic protected by law.

Equal Opportunity Employer

This employer is required to notify all applicants of their rights pursuant to federal employment laws.
For further information, please review the Know Your Rights notice from the Department of Labor.