Strategic Regulatory Affairs Manager

Aprecia Pharmaceuticals, LLC; Mason (OH); Sur place; USD 90 000 - 120 000; Plein temps

Résumé du poste

Aprecia Pharmaceuticals, LLC is seeking a Regulatory Affairs Manager in Mason, Ohio, responsible for the preparation, review, and submission of regulatory filings for drug products. The role includes managing submissions for NDAs, ANDAs, and maintaining compliance with FDA regulations.

Ideal candidates should have at least a B.S. in a related field, 6 years of experience in the pharmaceutical industry, and excellent communication skills. This position may require up to 10% travel and offers a dynamic work environment.

Qualifications

• Minimum 6 years of prior experience in the pharmaceutical industry.
• Less experience may be acceptable with a graduate degree.
• Strong familiarity with FDA pharmaceutical regulations.

Responsabilités

• Prepare and review regulatory filings for drug registrations.
• Work with cross-functional teams for regulatory submissions.
• Ensure eCTD submissions meet regulatory requirements.
• Prepare IND, NDA, and other regulatory submissions.
• Stay current with FDA regulations.
• Review and approve GMP documents for the RA department.

Connaissances

Excellent oral and written communication skills

Strong problem solving and critical thinking skills

Strong organizational skills and attention to detail

Strong familiarity with MSOffice

Working knowledge of cGMPs

Strong command of internet search tools

Good time management

Able to operate successfully in a team environment

Strong interpersonal and influencing skills

Formation

B.S. degree in Biology, Chemistry, or Allied Health Sciences

M.S. degree in Pharmacy or related field

Description du poste

Aprecia Pharmaceuticals, LLC is seeking a Regulatory Affairs Manager in Mason, Ohio, responsible for the preparation, review, and submission of regulatory filings for drug products. The role includes managing submissions for NDAs, ANDAs, and maintaining compliance with FDA regulations.

Ideal candidates should have at least a B.S. in a related field, 6 years of experience in the pharmaceutical industry, and excellent communication skills. This position may require up to 10% travel and offers a dynamic work environment.