REGULATORY ADVISOR

JOB RESPONSIBILITIES:

The Regulatory Advisor provides senior regulatory and technical guidance to support compliant manufacturing, new product introduction, and sustained inspection readiness across Formulated Solutions. The role translates regulatory expectations into practical recommendations for Quality, Operations, Technical Services, Product Development, and executive leadership. The role supports the processes needed for pharmaceutical and combination product programs. This is a senior individual contributor position that partners with the Regulatory Affairs Manager and site Quality leaders. The position carries full Quality authority, equivalent to the decision-making authority of a Site Head of Quality, to support the business across both manufacturing sites. The Regulatory Advisor exercises independent Quality judgment within the company’s quality system and reports to the Vice President of Quality.

ESSENTIAL DUTIES AND RESPONSIBILITIES:

• Quality Authority and Decision Making
• The Regulatory Advisor reports to the Vice President of Quality and works with the Regulatory Affairs Manager, site Quality leaders, laboratory management, Operations, Technical Services, Product Development, Supply Chain, and Legal. The Regulatory Affairs Manager retains ownership of assigned regulatory affairs processes, including product classification, labeling and claims review, market access, and submissions. The Advisor supplies technical guidance and review within those processes.
• The Regulatory Advisor is granted full Quality authority equivalent to a Site Head of Quality for activities within the assigned scope across Largo and Cleveland. This authority includes disposition of raw materials, components, bulk and finished products; approval or rejection of quality records, investigations, deviations, CAPAs, change controls, validation documents, and quality risk assessments; and decisions to hold, stop, or resume manufacturing, testing, release, or shipment based on product quality, patient safety, or compliance considerations. The Advisor may require corrective actions and withhold approval or disposition when requirements are not met. These decisions are binding within the assigned scope and carry the same accountability as decisions made by a Site Head of Quality.
• The Advisor exercises this authority in accordance with applicable regulations, approved procedures, customer quality agreements, and required training and system authorization. The Vice President of Quality establishes assignments and resolves conflicting Quality decisions; significant risks and unresolved disagreements must be promptly escalated, with applicable holds maintained pending resolution. Regulatory commitments and external communications follow established company approval processes.
• Regulatory Compliance and Strategy
• Provide documented regulatory assessments and practical recommendations for OTC drugs, cosmetics, prescription drug programs, medical devices, and combination products, as applicable to the company’s manufacturing activities.
• Monitor relevant regulatory and compendial developments, assess their impact with Regulatory Affairs, and help functional owners establish implementation plans.
• New Product and Pharmaceutical Readiness
• Advise on new product feasibility, technology transfer, validation strategies, manufacturing controls, and readiness requirements before project commitments, pilot manufacture, and commercial introduction.
• Assess regulatory implications of proposed changes to products, processes, equipment, facilities, testing, suppliers, and manufacturing locations through established change control processes.
• Provide technical input on qualification and validation strategies, cleaning and cross contamination controls, process validation, analytical methods, and stability programs in partnership with responsible subject matter experts.
• Raw Material Compliance
• Support raw material testing and specification compliance, including compendial alignment, supplier qualification strategies, and evaluation of proposed controls with Quality and laboratory leadership.
• Inspection Readiness and Quality System Support
• Support inspection preparation, regulatory correspondence, responses to agency findings, and customer audit responses; coordinate proposed statements and commitments with Quality leadership and Legal as appropriate.
• Review significant investigations, deviations, CAPAs, and quality risk assessments when regulatory expertise is needed; identify whether additional evaluation or escalation is warranted.
• Training and Business Support
• Develop and deliver practical regulatory and GMP training, and review procedures and technical documents for consistency with applicable expectations and approved commitments.
• Participate in customer regulatory discussions when designated by leadership, presenting positions aligned with approved company assessments and communication responsibilities.
• Provide concise updates to the Vice President of Quality and executive leadership on regulatory risks, decisions needed, compliance priorities, and resource requirements.
• Other duties as assigned.

CRITICAL SKILLS AND ABILITIES:

• Strong technical writing, risk assessment, training, and cross functional communication skills; ability to distinguish regulatory requirements from recommendations and document the basis for advice.
• Ability to exercise independent Quality judgment, make timely disposition decisions, and escalate significant compliance risks.
• Ability to coordinate cross functional priorities and communicate clearly with executive leadership, customers, and regulatory authorities.

EDUCATION AND EXPERIENCE:

• Bachelor’s degree in chemistry, pharmacy, biology, engineering, or a related scientific discipline required; an advanced degree is preferred.
• Typically 10 or more years of relevant pharmaceutical regulatory, quality, technical compliance, or manufacturing experience, including senior advisory responsibility.
• Demonstrated experience supporting FDA inspections, regulatory responses, and implementation of sustainable GMP controls.
• Working knowledge of applicable drug GMP requirements, combination product and device quality system requirements, compendial standards, and relevant ICH and ISO frameworks.
• Experience with CDMO operations, customer technical interfaces, and products such as nasal sprays, aerosols, creams, gels, and lotions preferred.