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Position Title: Regulatory Affairs Specialist II – Labeling and Promotion
Classification: Exempt
Reports to: Regulatory Affairs Manager

Summary/Objective

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.

Essential Functions

Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

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

Supervisory Responsibility

N/A

Work Environment

This job operates in a professional office environment. This job can be onsite, remote, or hybrid. This role routinely uses standard office equipment such as computers, phones, and printers.

Physical Demands

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job.

While performing the duties of this position, the employee is regularly required to sit and use hands to finger, handle, or feel objects, tools or controls. The employee is frequently required to reach with hands and arms and talk or hear. The employee is occasionally required to walk. Specific vision abilities required by this position include close vision, color vision and the ability to adjust focus.

Position Type/Expected Hours of Work

This is a full-time position. Days and hours of work are Monday through Friday, 8:00 a.m. to 4:30 p.m. Occasional early morning, evening, and weekend work may be required as job duties demand. Alternate hours can be arranged with management based on meeting schedules, etc.

Travel

Local candidates: Travel is primarily local during the business day, although some out-of-area and overnight travel may be expected.

Remote workers: Periodic travel to Sovereign is expected for business needs – generally once or twice a year for 3-5 days per visit.

Required Education and Experience

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

Preferred Education and Experience

1. RAC certification a plus but not required.

Work Authorization/Security Clearance (if applicable)

N/A

Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice.