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Integrations Program Manager
Meta
Salem, OR
Meta is seeking an Integrations Program Manager to lead complex, cross-functional integration programs that connect Meta's products, platforms, and operations at scale. In this role, you…
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Audiologist - Remote
GN Hearing
Salem, OR
…business. Leveraging GN's expertise and Jabra's pioneering audio engineering helps us make our hearing care even more accessible and…
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Proposal & Channel Partnerships Manager
Jacobs
Portland, OR
The Proposal & Channel Partnerships Manager will lead StreetLight’s response to RFPs, RFIs, and other formal opportunities - from finding and qualifying opportunities through coordinating…
Added 1 min ago
VH
Physician (Deputy Chief of Staff)
Veterans Health Administration
Salisbury, NC
- $280,000 to $400,000 USD / year
Added 1 min ago
CN
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Commander, Navy Installations Command
Newport, RI
- $22 USD / hour
Working knowledge of the planning process involved in cooking an entire meal including different preparation methods for various food items, the necessary time for cooking these different…
Added 1 min ago
AN
SUPERVISORY IT SPECIALIST (SYSTEMS ADMINISTRATION)
Army National Guard Units
Columbia, SC
- $89,508 to $116,362 USD / year
…applicant to understand the stages required to automate a work process. Experience may have been gained in work such as computer operator or assistant, computer sales representative,…
Added 1 min ago
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GEOLOGIST
Bureau of Reclamation
Lakewood, CO · Billings, MT
- $106,437 to $154,280 USD / year
Develops, performs, and provides technical peer review of simple to complex engineering geologic field studies for the purpose of gathering engineering geologic data applicable to the…
Added 4 mins ago
BP
Program Analyst
Bonneville Power Administration
Vancouver, WA
- $80,465 to $125,378 USD / year
Conduct detailed analyses of functions and work processes of broad technical programs; monitoring the project lifecycle process and communicating risks associated with costs, resources and…
Added 4 mins ago
UA
Civil Engineer
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Vicksburg, MS
- $118,204 to $145,483 USD / year
About the Position: Serves as a Civil Engineer Subject Matter Expert (SME) and Engineering Technical Lead for certain projects as designated by the E&C Division Chief.Duties
Added 6 mins ago
Enterprise Account Manager
Eficode
Boston · Philadelphia · Washington · New York · Chicago
We're looking for an experienced Enterprise Account Manager to join our growing US Sales team, taking ownership of a portfolio of approximately 10–15 strategic enterprise accounts.
Added 6 mins ago
AN
SURFACE MAINTENANCE MECHANIC
Army National Guard Units
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- $36 to $43 USD / hour
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Added 7 mins ago
Global Supply Chain & Purchasing Manager - Aerospace
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Blue Bell, PA, PA · Falconer, NY, NY
As part of the continued transformation of SKF Aerospace, we are looking for a Global Supply Chain & Purchasing Manager to lead two critical, connected agendas across our global factory…
Added 9 mins ago
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Engineering Technician
Bureau of Reclamation
Boise, ID
- $61,722 to $97,087 USD / year
Reclamation is seeking a career professional looking for an opportunity to capitalize on their expertise as a Engineering Technician. Make a difference in the West by assisting in meeting…
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IT Cybersecurity Specialist (ENTARCH)
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Washington, DC
- $121,785 to $158,322 USD / year
Applying System Engineering Life Cycle (SELC) principles to all IT projects.
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Commissioning Manager
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As a Senior Commissioning and Start-Up, Manager, you will join a collaborative team delivering CSU services to clients who leads the critical transition of a fabrication facility (fab) from…
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Maintain a hard copy or electronic calendar for manager(s).
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Sr. Process Manager II, Boise, ID or Clay, NY
Micron Technology, Inc.
Clay, NY
- $96,000 to $173,000 USD / year
As a Sr. Process Manager II, Boise or Clay at Micron, you will play a pivotal role in leading and refining our processes to ensure seamless and compliant project execution. This is an…
Added 13 mins ago
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Program Planner
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…BusinessReworld partners with businesses by offering cutting-edge engineering and innovative solutions, to help customers reduce, reuse, recycle and recover value from waste streams and…
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Consumer Safety Officer (Planning)
Food and Drug Administration
FDA â US Locations, United States
- $106,437 to $172,980 USD / year
…physical sciences, food technology, nutrition, medical science, engineering, epidemiology, veterinary medical science, legal investigations, law enforcement, or related scientific fields…
Added 13 mins ago
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Operations Research Analyst
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Fort Belvoir, VA · Dahlgren, VA
- $143,913 to $197,200 USD / year
The following are illustrative of acceptable courses: optimization; mathematical modeling; queuing theory; engineering; physics (except descriptive or survey courses); econometrics;…
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Director, Construction Project Management
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Acting as the Owner’s representative, the Senior Construction Manager ensures that all engineering partners, EPC/EPCM contractors, construction management firms, subcontractors, and…
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…progress, risk, change management, and performance reporting across engineering, procurement, construction, equipment installation, commissioning, and…
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Mobile Engineer
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This job is part of the Engineering and Technical Services job function. They are responsible for providing support, preventive maintenance, and repairs on equipment and systems.
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Sr Electrical Engineer
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This position provides advanced engineering support on any operating or capital rolling stock projects and efforts within the Maintenance of Equipment department. This includes design,…

FORMULATED Solutions LLC

REGULATORY ADVISOR

Largo, FL, United States

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Job details

Posting language: English

Original job description

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.

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Skills

Decision making
Regulatory affairs
Supply chain management
Regulatory compliance
Medical devices
Cleaning
Test materials
Leadership
Inspection
Good manufacturing practices
Communication skills
Technical writing
Hazard assessment

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