AD/Director, Regulatory Affairs

Paragon Bioservices, Inc. - Baltimore, MD2.7

30+ days ago
Paragon Bioservices, Inc. (PBI) is a growing
biopharmaceutical contract development and manufacturing organization with an
internationally recognized tradition of quality and service. PBI provides
process development and GMP manufacturing services for Phase I/II clinical
trials to industry leaders as well as innovative start-ups utilizing novel
technologies to produce state-of-the-art vaccines and therapies for people when
they are most in need. As a PBI employee, you will actively contribute to the
delivery of our services and products to our customers and their patients

The Regulatory Affairs Leader will be
responsible for supporting clients, US and EU regulatory submission strategies.
He/She will be responsible for drafting and reviewing submission documents and
interacting with our clients.

Key Responsibilities include, but are not limited to:
Support our clients with required
documents for CMC sections of regulatory submissions.

Determine and communicate submission
and approval requirements early in the product lifecycle to assure that project
plans are aligned with submission strategies and regulatory guidelines.

Write and review regulatory
documents with a critical eye for suitability for submissions to FDA and any
other regulatory agencies as need be.

Under the direction of the VP of
Quality and Regulatory Affairs, handle the preparation of submission packages
for regulatory agencies in compliance with applicable requirements & best
practices. Identify issues early in the submission preparation process that
could impact timelines/risks.

Participate in multidisciplinary
project teams within the client providing guidance and direction on current
regulatory pathways and expectations.

Assist with the companies progress
into commercial readiness efforts

Stay current on changes to the
regulatory environment that could impact Paragon’s contract manufacturing
strategies.

Monitor applications under review,
manage and track submission and maintenance processes to support regulatory
applications.

Experience & Education:
Bachelor's Degree in a scientific or engineering discipline

10 or more years in Regulatory Affairs in the area of
Biologics

Experience in the hands-on preparation of IND, IMPD or BLA
submissions for Biological products
Interactions with the US, Canadian, European, and other
international regulatory authorities
Prior facilitation of face-to-face meetings with regulators
Ability to build credibility and
influence internal departments and client representatives
Experience in working with
regulatory consultants and contract research organizations
Fluency in Microsoft Office
applications (WORD, PowerPoint, EXCEL, Project)
Strong organizational and project management
skills

Paragon Bioservices is proud to be an Equal Employment
Opportunity and Affirmative Action employer. We do not discriminate based upon
race, religion, color, national origin, gender (including pregnancy,
childbirth, or related medical conditions), sexual orientation, gender
identity, gender expression, age, status as a protected veteran, status as an
individual with a disability, or other applicable legally protected characteristics.
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