Regulatory Affairs Manager – PHD

31 Jul, 2020

Jobs

Regulatory Affairs Manager – PHD

Proctor & Gamble
Cincinnati, OH

DESCRIPTION

Would you love to work in a technically challenging and globally diverse business environment? Procter & Gamble’s Global Product Stewardship organization in Cincinnati has an immediate opening for an entry level PhD Regulatory Manager! The successful candidate will provide regulatory support for new and currently marketed FDA regulated consumer products and upstream technologies.

RESPONSIBILITIES INCLUDE

  • Provide technical leadership for Regulatory compliance to global R&D project teams for complex and innovative technologies through all stages of product development.
  • Interact with all relevant partners to define the regulatory and development strategy to deliver new product innovation to market
  • Conduct internal meetings, and external meetings with FDA as needed
  • Prepare regulatory documents for submission to the FDA and ensure submissions comply with applicable regulations and guidance documents.
  • Subject Matter Expert (SME) in applicable regulations governing FDA-regulated products
  • Provide daily support for projects, including claims and marketing strategies and label copy development.
  • Evaluate program risks and develop mitigation strategies. Clearly communicate opportunities and risks to management

QUALIFICATIONS

PREFERRED QUALIFICATIONS

  • PharmD or PhD in scientific field of study such as Biology, Chemistry or other related life science
  • 3+ years of experience in regulatory affairs with proven experience setting and executing strategy with IND, NDA, ANDA filings.

We are committed to providing equal opportunities in employment. We value diversity and do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.

All will receive consideration for employment without regard to race, color, religion, sex, national origin, protected veteran status, disability status, age, sexual orientation, gender identity and expression, marital status, citizenship, HIV/AIDS status or any other legally protected factor.

Immigration sponsorship is not available for this position, except in rare situations based on Procter & Gamble’s sole discretion. Applicants for U.S. based positions are eligible to work in the U.S. without the need for current or future sponsorship. We do not sponsor for permanent residency. Any exceptions are based on the Company’s specific business needs at the time and place of recruitment as well as the particular qualifications of the individual.

Procter & Gamble participates in e-verify as required by law.

Qualified individuals will not be disadvantaged based on being unemployed.

Learn more here

Job posted: 2020-07-31