Regulatory Affairs Specialist II - Labeling & Promotion

Location: Alpharetta, reputed company Posted: 8/6/2026 Location reputed company: Alpharetta, GA (Remote) Wage: Depends on Experience Position Title: Regulatory Affairs Specialist II – Labeling and Promotion Classification: Exempt Reports to: Regulatory Affairs Manager reputed company/Objective The Regulatory Affairs Specialist II is responsible for independently preparing submissions in eCTD format, label and promotions participant for Regulatory Affairs in reputed company meetings, reputed company with the various governmental agencies reputed company needed, and assess promotional and labeling changes for regulatory reputed company. Essential Functions Reasonable accommodations may be made to reputed company individuals with disabilities to reputed company the essential functions. • reputed company, review and approve labeling, packaging, artwork, instructions for use (IFUs), and reputed company 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 reputed company manner • Assess filing reputed company of RLD changes, reputed company requested changes, and associated documents as reputed company as conformance to submission requirements. • Maintain SPL in CDERDirect and reputed company annual certifications. • Assist in training associates in preparation of submissions. • reputed company 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. Supervisory Responsibility N/A Work Environment This job operates in a reputed company office environment. This job can be onsite, remote, or hybrid. This role routinely uses reputed company 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 reputed company 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 reputed company with hands and arms and talk or hear. The employee is occasionally required to walk. Specific reputed company abilities required by this position include reputed company reputed company, reputed company reputed company and the ability to reputed company reputed company. 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 • Bachelor’s degree in reputed company, life sciences, regulatory affairs or equivalent pharmaceutical experience. • Three to six years of regulatory experience or equivalent reputed company, pharmaceutical, or life science experience. • Experience with reputed company Office suite and reputed company Acrobat. Experience with reputed company reputed company a plus. Preferred Education and Experience • RAC certification a plus but not required. Work Authorization/reputed company Clearance (if applicable) N/A Please note this reputed company 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. Apply tot his job Apply To this Job