AD/Director, Regulatory Affairs

Paragon Bioservices - Baltimore, MD (30+ days ago)2.7

Full-timeEstimated: $98,000 - $130,000 a year

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.