P&G is the largest consumer packaged goods company in the world. We have operations in over 75 countries, with 65 trusted brands that improve lives for 5 billion consumers worldwide. This brings many advantages, including the opportunity for our employees to enjoy a diverse and rewarding lifelong career filled with new and exciting challenges.

Are you looking for a position that offers a rewarding lifelong career filled with new and exciting challenges? P&G is looking for a US Regulatory Manager - Scientist PhD or PharmD.

US REGULATORY MANAGER - SCIENTIST PHD OR PHARMD

Guides and influences technical project direction and solves significant technical problems by leveraging scientific/engineering skills and strong foundational GPS understanding developed through hands-on experimentation/application. Performs Application work and demonstrates implementation skills leveraging knowledge that moves projects forward and also begins to gain exposure to and demonstrate initial proficiency in performing integration work. Acts as point of accountability within the Global Safety Surveillance & Analysis function for post-marketing adverse event data assessment and interpretation. Demonstrates expertise (understanding of technical fundamentals/practical application) in regulatory with expertise in supporting one or more categories within a BU. Critically evaluates regulatory laws, develops regulatory strategies, identifies/measures key issues/risks and develops strategic plans to address these issues. Reapplies proven regulatory strategies; previous successful approaches.

Qualifications

EDUCATION:

An Associate’s Degree in an Engineering or Mechanical field or a High School diploma with proven experience and interests.

• Develop and lead regulatory strategies to support consumer and clinical testing, claims, copy development, market clearances and artwork development of new and existing product innovations.
• Enable a more holistic approach to the management of US compliance efforts for the various categories of Oral Care products, from study request throughout their lifetime in the market.
• Assess the competitive landscape and proactively build actionable but enabling regulatory business strategies, actions to be taken regarding compliance opportunities or regulatory vulnerabilities.
• Participate and manage FDA submissions, meetings, and formal interactions with regulatory agencies.
• Monitor applicable regulations/standards, FDA, State regulations in the US

QUALIFICATIONS

Regulatory Manager – PharmD or PhD. in life science field or equivalent experience in FDA regulatory affairs preferred with a strong willingness to learn complex regulatory landscape, thru compliance strategies for FDA, regulated products, US regulations. The individual in this role must be able to independently formulate logical and data-based regulatory positions, to communicate clearly and manage questions in real time or discern when escalation is needed. Proactive and agile project leadership, issue management, troubleshooting and solution driving skills will contribute to success in this assignment.

Leadership - Will be a key leader to enable a growing Oral Care business in compliance with current and forthcoming US regulations. Leadership will be crucial to succeed in this fast-paced business, complex regulatory environment, and within broad multi-functional teams.

Collaboration - Able to effectively partner within multi-functional teams and peers to develop win-win solutions for the Business that enable compliance with relevant regulations by critical listening, effective partnership, and ability to translate needs into effective and timely solutions that enable the solutions to address project needs. Strong collaborative and communication skills enabling excellent working relationships across Regulatory and R&D to ensure a seamless digital development process to support Oral Care initiatives and key regulatory needs.

Agility/Capacity - Will be expected to manage several priorities at the same time, knowing when to look to re-apply solutions and strategies that lead to simplification and efficiency. Able to flow to the work to enable support of key initiatives.