Regulatory Affairs Specialist II: Labeling & Promotions

Avion Pharmaceuticals, LLC; Alpharetta (GA); Hybrid; USD 75,000 - 110,000; Full time

Job summary

Avion Pharmaceuticals, LLC is seeking a Regulatory Affairs Specialist II to independently prepare eCTD submissions and oversee labeling and promotional materials for regulatory compliance. The role involves interacting with regulatory agencies, collaborating with cross-functional teams, and ensuring timely document delivery.

The ideal candidate has 3–6 years of regulatory experience, a strong command of MS Office and Adobe Acrobat, and a background in chemistry or life sciences.

Qualifications

• Bachelor's degree in chemistry, life sciences, regulatory affairs or equivalent pharmaceutical experience.
• 3–6 years of regulatory experience or equivalent quality, pharmaceutical, or life science experience.
• Experience with Microsoft Office suite and Adobe Acrobat; Adobe Illustrator a plus.

Responsibilities

• Generate, review and approve labeling, packaging, IFUs and related docs for compliance.
• Review and approve promotional materials in line with regulatory requirements.
• Prepare complete submissions in eCTD format per checklists.
• Collaborate with cross-functional teams to support development and production.
• Interact with agencies (FDA, DEA, etc.) in audits and meetings as needed.
• Contribute to SOP updates and regulatory best practices.

Skills

MS Office proficiency

Adobe Acrobat

Adobe Illustrator (nice to have)

Education

Bachelor's degree in chemistry, life sciences, or regulatory affairs

Tools

Microsoft Office

Adobe Acrobat

Adobe Illustrator

Job description

Avion Pharmaceuticals, LLC is seeking a Regulatory Affairs Specialist II to independently prepare eCTD submissions and oversee labeling and promotional materials for regulatory compliance. The role involves interacting with regulatory agencies, collaborating with cross-functional teams, and ensuring timely document delivery.

The ideal candidate has 3–6 years of regulatory experience, a strong command of MS Office and Adobe Acrobat, and a background in chemistry or life sciences.