Regulatory Affairs Specialist II - Labeling & Promotion

Avion Pharmaceuticals•Alpharetta, GA

17h•Hybrid

About The Position

The Regulatory Affairs Specialist II is responsible for independently preparing submissions in eCTD format, label and promotions participant for Regulatory Affairs in client meetings, interact with the various governmental agencies when needed, and assess promotional and labeling changes for regulatory impact. This role involves generating, reviewing, and approving labeling, packaging, artwork, instructions for use (IFUs), and related documentation to ensure compliance with applicable regulations and approved registrations. It also supports the review and approval of promotional, educational, and marketing materials, and independently prepares complete submissions in eCTD format for label supplements, OPDP materials, Annual Reports, and other product correspondence. The specialist collaborates with cross-functional teams, proactively works with clients, assesses the impact of changes on filings, maintains SPL in CDERDirect, and assists in training associates. Interaction with agencies like the FDA and DEA for audits and meetings is also a key function, along with contributing to process improvements and SOP updates.

Requirements

Bachelor’s degree in chemistry, life sciences, regulatory affairs or equivalent pharmaceutical experience.
Three to six years of regulatory experience or equivalent quality, pharmaceutical, or life science experience.
Experience with Microsoft Office suite and Adobe Acrobat.
Experience with Adobe Illustrator a plus.

Nice To Haves

RAC certification a plus but not required.

Responsibilities

Generate, review and approve labeling, packaging, artwork, instructions for use (IFUs), and related documentation to ensure compliance with applicable regulations and approved registrations.
Support review and approval of promotional, educational, and marketing materials in accordance with regulatory and internal requirements.
Independently prepare complete submissions in eCTD format according to supplied checklist(s) – Label supplements, OPDP materials, Annual Reports, and other product correspondence as needed.
Collaborate with cross-functional teams to support development and production.
Proactively work with clients to ensure successful working relationship by providing documentation and information in a timely manner.
Assess filing impact of RLD changes, client requested changes, and associated documents as well as conformance to submission requirements.
Maintain SPL in CDERDirect and perform annual certifications.
Assist in training associates in preparation of submissions.
Interact with the various Agencies (FDA, DEA, TCEQ, etc.) in audits and other meetings as needed.
Contribute to process improvements, SOP updates, and regulatory best practices.
Other duties as assigned.