Senior Regulatory Affairs Specialist
Company: Supernus Pharmaceuticals, Inc.
Posted on: June 18, 2022
Job Summary: This position will act as the pharmaceutical
product labeling coordinator of several labeling projects at a time
from creation of spec to completion. Will work within a
collaborative cross-functional team that includes external vendors,
internal Regulatory colleagues, Supply Chain, Quality and
potentially Commercial Products Manufacturing.Essential Duties &
- Develop an understanding of FDA and USDA labeling regulations
and company policies.
- Act as the project manager for all labeling projects, working
with third party vendors to ensure completion of projects.
- Review and critique documents for submission to FDA in support
of original applications, pre-approval amendments and post approval
supplements and annual reports.
- Review documents for accuracy, clarity, and consistency of
content and format; other non-grammatical inconsistencies observed
such as with artwork or layout when reviewing material vs expected
layouts per regulations
- Review packaging proofs to ensure accuracy and regulatory
- Develop and maintain paperwork for regulatory, and internal
- Works internally with regulatory, clinical, drug delivery
sciences, quality and other internal functional areas and with
external regulatory agencies to ensure timely regulatory and
quality compliance, and to support business objectives as
- Other Duties as Assigned.Supervisory Responsibilities:
- N/AKnowledge & Other Qualifications:
- Bachelor's degree (Preferred in the sciences)
- 4+ years' related experience with project management
- Experience within the Pharmaceutical Industry highly
- Familiarity with labeling-related regulations and industry
practice experience highly preferred.
- Demonstrated capabilities in meticulous work practices and
attention to detail.
- Project management experience with the ability to handle
multiple projects at once.
- Ability to work with vendors to ensure quality and build
effective relationships. 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
- 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
- Authorized to legally work in the United States without visa
sponsorship.Physical Requirements/Work Environment/Travel
- Sedentary work. Exerting up to 10 pounds of force occasionally
and/or carrying objects. Sedentary work involves sitting most of
- 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 conditionsSupernus 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.
Keywords: Supernus Pharmaceuticals, Inc., Rockville , Senior Regulatory Affairs Specialist, Other , Rockville, Maryland
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