Remote Senior Regulatory Affairs Associate eCTD Submissions

Alora Pharmaceuticals, LLC.; Alpharetta (GA); On-site; USD 90,000 - 120,000; Full time

Job summary

Alora Pharmaceuticals, LLC. is seeking a Senior Regulatory Affairs Associate in Alpharetta, GA. You will prepare eCTD submissions, liaise with clients and agencies, and assess regulatory changes for impact.

The role involves cross‑department collaboration to ensure timely, compliant submissions. Ideal candidates hold a chemistry/life sciences degree or 5–7 years of relevant experience, with familiarity in CDERDirect, eCTD publishing, and SPL Xforms.

Qualifications

• Bachelor's degree in chemistry or life sciences or 5–7 years of applicable experience.
• Working understanding of Word, Excel, Acrobat.
• Preparation and maintenance of eCTD submissions and lifecycle.

Responsibilities

• Independently gather documentation, draft and prepare eCTD-compliant submissions.
• Review the work of regulatory staff for content and validation.
• Coordinate with other departments to meet submission deadlines.
• Revise labeling per FDA and changes to RLD.
• Participate in audits by federal, state, local agencies.
• Train on new regulations and agency webinars.
• Represent the department at meetings and provide regulatory advice.

Skills

eCTD submissions

Regulatory liaison

Documentation review

Timeline management

Education

Bachelor's degree in chemistry or life sciences

5–7 years of applicable experience

Tools

CDERDirect

Electronic Submissions Gateway

SPL Xforms

eCTD publishing systems

Job description

Alora Pharmaceuticals, LLC. is seeking a Senior Regulatory Affairs Associate in Alpharetta, GA. You will prepare eCTD submissions, liaise with clients and agencies, and assess regulatory changes for impact.

The role involves cross‑department collaboration to ensure timely, compliant submissions. Ideal candidates hold a chemistry/life sciences degree or 5–7 years of relevant experience, with familiarity in CDERDirect, eCTD publishing, and SPL Xforms.