Manager Regulatory Intelligence

Zoetis Inc; Oregon; Ibrido; USD 120.000 - 180.000; Tempo pieno

Vantaggi offerti da questo lavoro

Benefits package

401K match & profit sharing

4 weeks vacation

Descrizione del lavoro

Zoetis Inc. is seeking a senior Regulatory Affairs professional to lead global surveillance workstreams, interpret evolving regulatory requirements, and coordinate cross-functional impact assessments.

This role focuses on USA & Canada regulatory landscapes, including packaging, devices, and environmental considerations. The candidate will drive regulatory intelligence communications, manage external consultations, and engage with industry associations.

Competenze

• Bachelor’s degree in a scientific discipline (e.g., life sciences, pharmacy, regulatory affairs, or related field).
• Minimum 5 years of experience in Regulatory Affairs or related field.
• Demonstrated track record of independently managing regulatory deliverables and leading cross-functional workstreams or to act as Subject Matter Expert within a cross functional team.
• Experience with regulatory intelligence systems or tools required at this level.

Mansioni

• Own and lead assigned global surveillance workstreams, independently monitoring, interpreting, and communicating evolving regulatory requirements to the broader Global Regulatory Affairs team.
• Oversee monitoring across compendial changes, chemical requirements, pharmaceutical and non-pharmaceutical packaging, diagnostics, medical devices, and GMP/Environmental inspectional activities.
• Coordinate impact assessments of new or changed requirements with cross-functional partners (EHS, VMRD, Quality, Global Manufacturing, Public Affairs, Legal). Ensure assessments are completed and actions tracked to closure.
• Lead development and distribution of regulatory intelligence newsletters, watch notifications, and ad hoc query responses; review RI outputs for quality.

Conoscenze

Regulatory Affairs

Cross-functional Leadership

Regulatory Intelligence

AI Tools

Formazione

Bachelor's in life sciences/regulatory

Master/PhD in related field

Strumenti

Regulatory intelligence systems

Descrizione del lavoro

Position Responsibilities

• Global Surveillance Leadership (USA & Canada focus): Own and lead assigned global surveillance workstreams, independently monitoring, interpreting, and communicating evolving regulatory requirements to the broader Global Regulatory Affairs team.


• Surveillance Scope: Oversee monitoring across compendial changes, chemical requirements, pharmaceutical and non-pharmaceutical packaging, diagnostics, medical devices, and GMP/Environmental inspectional activities


• Cross-Functional Impact Assessment Coordination: Take the lead role in coordinating impact assessments of new or changed requirements, working with cross-functional partners (EHS, VMRD, Quality, Global Manufacturing, Public Affairs, Legal). Ensure assessments are completed, compliance plans are documented, and actions are tracked to closure.


• Regulatory Intelligence Communications: Lead the development and distribution of regulatory intelligence newsletters, regulatory watch notifications, and ad hoc query responses. Review and quality-check RI communication outputs produced by team members.


• External Consultation Responses: Coordinate timely company responses to draft guidance, standards, and consultations. Manage the process of engaging SMEs, consolidating inputs, and ensuring submissions reflect a clear, defensible company position.


• Industry Association Representation: Represent the company in relevant industry associations (e.g., AHI) and regulatory forums. Contribute to working groups and help shape industry-level regulatory positions.


• EPR Reporting & Producer Responsibility Administration: May serve as the internal administrator for Producer Responsibility Organization (PRO) obligations. Manage data submission of Extended Producer Responsibility (EPR) reporting data through timely and accurate filing with state and/or national programs, coordinating with relevant internal functions (Regulatory Affairs, EHS, Legal, Packaging, Supply Chain) to gather required data and ensure program compliance.


• Subject Matter Expert: based on the company needs, for new and emerging regulations or requirements, act on occasion and on temporary basis as the designated subject matter expert on cross-functional project teams, governance bodies, and working groups.


• External Consultant Management: Coordinate external consultant activities including scope definition, budget review and approval, and ongoing liaison to ensure project deliverables are met on time and within budget.


• Inquiry Management: Serve as the primary point of contact for specific internal stakeholder groups for RI-related inquiries; coordinate timely and well-documented responses to changing regulatory requirements.


• Risk & Compliance Trending: Interpret regulatory compliance trends, assess emerging risks, and prepare action plans and briefings for Governance forums. Bring forward risks proactively rather than reactively.


• Process Improvement: Contribute to the design, documentation, and sustainability of RI processes and SOPs. Identify gaps and propose solutions to continuously improve team effectiveness.


• AI & Technology Tools: Champion the use of AI-enabled regulatory intelligence platforms. Lead or contribute to the selection, piloting, and implementation of RI-specialized digital tools; train team members on new capabilities.

Education & Experience Required

• Bachelor’s degree in a scientific discipline (e.g., life sciences, pharmacy, regulatory affairs, or related field).


• Minimum 5 years of experience in Regulatory Affairs or related field.


• Demonstrated track record of independently managing regulatory deliverables and leading cross-functional workstreams or to act as Subject Matter Expert within a cross functional team.


• Experience with regulatory intelligence systems or tools required at this level.

Desirable Attributes

• Master’s, or PhD degree in a scientific discipline (e.g., life sciences, pharmacy, regulatory affairs, or related field).


• Previous interactions with FDA, USDA, or other US authorities strongly preferred.


• Experience in a Regulatory Intelligence function is preferred


• General knowledge of (bio) pharmaceutical research and development, authorization and post-marketing compliance of medicinal products. Good understanding of CMC is preferred.


• Experience as an active participant or representative in industry associations (e.g., AHI, Animal Health Europe, EFPIA, PhRMA, ISPE, PDA) with demonstrated contribution to working groups or policy discussions.


• Working knowledge of animal health product laws, regulations, and the regulatory policy-making process.


• Understanding of chemical substances laws and regulations.


• Familiarity with sustainability and packaging regulations, including US State EPR reporting frameworks and PRO data submission requirements.


• Experience managing a portfolio of regulatory liaison activities directly with Global Health Authorities.


• Hands-on experience with AI software and GenAI technology applied to regulatory intelligence workflows.

The US base salary range for this full-time position is $120,000- $180,000.
Our salary ranges are determined by role, level, and location. The range displayed on each job posting reflects the base pay target range for new hire salaries for the position. Within the range, individual pay is determined by work location and additional factors, including job-related skills, experience, and relevant education or training.
This position is also eligible for short-term incentive compensation.
This position is also eligible for long-term incentives.
In addition to compensation, Zoetis offers a comprehensive benefits package that supports the physical, emotional and financial wellbeing of our colleagues and their families including healthcare and insurance benefits beginning on day one, a 401K plan with a match and profit-sharing contribution from Zoetis, and 4 weeks of vacation. Visit zoetisbenefits.com to learn more.

Full timeRegularColleague

Zoetis is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status or any other protected classification. Disabled individuals are given an equal opportunity to use our online application system. We offer reasonable accommodations as an alternative if requested by an individual with a disability. Please contact Zoetis Colleague Services at to request an accommodation.

Zoetis also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as employment eligibility verification requirements of the Immigration and Nationality Act.

All applicants must possess or obtain authorization to work in the US for Zoetis. Zoetis retains sole and exclusive discretion to pursue sponsorship for the acquisition or maintenance of nonimmigrant status and employment eligibility, considering factors such as availability of qualified US workers. Individuals requiring sponsorship must disclose this fact.

Please note that Zoetis seeks information related to job applications from candidates for jobs in the U.S. solely via the following: (1) our company website at www.Zoetis.com/careers site, or (2) via email to/from addresses using only the Zoetis domain of “@zoetis.com”. In addition, Zoetis does not use Google Hangout for any recruitment related activities. Any solicitation or request for information related to job applications with Zoetis via any other means and/or utilizing email addresses with any other domain should be disregarded. In addition, Zoetis will never ask candidates to make any type of personal financial investment related to gaining employment with Zoetis.