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Added 2 mins ago
Sr. Manager, Accounting - CAM - CCM
Carlisle
Scottsdale, Arizona, AZ
The Sr. Manager, Accounting is the senior accounting leader for Carlisle Architectural Metals (CAM) and is accountable for delivering accurate, complete, and timely financial results in…
Added 5 mins ago
UG
RN Clinical Manager - Bear DE
UnitedHealth Group
Dover, DE
- $77,040 to $115,560 USD / year
As the Clinical Manager, you will provide leadership, supervision, and coordination of therapy services to ensure high-quality, compliant, and cost-effective patient care, while maintaining…
Added 8 mins ago
Safety Manager
Elite Transportation LLC
Wichita, KS
Added 8 mins ago
Clinical Nurse Coordinator Peds Sedation
HCA Healthcare
Wichita, KS
…through open, collaborative relationships with your direct manager or more formal opportunities through hospital councils and national nursing initiatives. You'll help shape decisions that…
Added 11 mins ago
BC
PSH PBV Case Manager
Brilliant Corners
Gardena, CA
- $52,998 USD / year
The Case Manager, Permanent Supportive Housing Project Based (PSH-PB) will provide intensive case management services to a caseload of up to 20 homeless individuals who are eligible for…
Added 11 mins ago
BC
PBV PSH Case Manager
Brilliant Corners
Historic Filipinotown, CA
- $52,998 USD / year
The Case Manager, Permanent Supportive Housing Project Based (PSH-PB) will provide intensive case management services to a caseload of up to 20 homeless individuals who are eligible for…
Added 13 mins ago
CD
Claims Representative
CONSUMER DEFENSE PARTNERS LLC
Boynton Beach, FL
- $20 to $22 USD / hour
Escalates any necessary scenario to the Department Manager for review and resolution.
Added 16 mins ago
MS
Senior Operations Manager- Access Center, Hicksville, Long Island, New York, Full Time, Days
Mount Sinai Health System
Huntington, NY
- $103,000 to $157,492 USD / year
- Full-time
The Senior Operations Manager is responsible for building and optimizing strong practice operations and leadership across assigned Mount Sinai Health System departments.
Added 20 mins ago
Property Manager
Quantum Real Estate Mgmt LLC
Alexandria, VA
Senior Property Manager – Affordable Housing & HOA
Added 20 mins ago
P
Liability Claims Specialist OR Sr. Liability Claims Specialist
PRISM
Folsom, CA
- $7,009 to $10,309 USD / month
…appropriate claim strategy, reserves, reimbursement, reinsurance and…
Added 32 mins ago
G
Personal Lines Account Manager
GPAC
Rock Island, IL
- $65,000 to $75,000 USD / year
…opportunity for you to join our team as a Personal Lines Account…
Added 32 mins ago
G
Personal Lines Account Manager
GPAC
Quincy, IL
- $65,000 to $75,000 USD / year
…opportunity for you to join our team as a Personal Lines Account…
Added 32 mins ago
G
Personal Lines Account Manager
GPAC
Burlington, IL
- $65,000 to $75,000 USD / year
…opportunity for you to join our team as a Personal Lines Account…
Added 36 mins ago
Associate Director, Accelerator Operations
Braven
Remote, United States
Surface operational risk early, drive high-stakes issues to resolution, and document risk classification and mitigation when a launch proceeds without clearing the gate
Added 36 mins ago
Associate Director, Accelerator Operations
Braven
Remote, United States
Surface operational risk early, drive high-stakes issues to resolution, and document risk classification and mitigation when a launch proceeds without clearing the gate
Added 36 mins ago
Associate Director, Accelerator Operations
Braven
Remote, United States
Surface operational risk early, drive high-stakes issues to resolution, and document risk classification and mitigation when a launch proceeds without clearing the gate
Added 36 mins ago
Associate Director, Accelerator Operations
Braven
Remote, United States
Surface operational risk early, drive high-stakes issues to resolution, and document risk classification and mitigation when a launch proceeds without clearing the gate
Added 36 mins ago
Associate Director, Technical Project Management
Braven
Remote, United States
…Project Management. This role will serve as a technical project manager for a specific domain area within the Systems Team, ensuring a standard project management methodology is embedded…
Added 36 mins ago
Associate Director, Technical Project Management
Braven
Remote, United States
…Project Management. This role will serve as a technical project manager for a specific domain area within the Systems Team, ensuring a standard project management methodology is embedded…
Added 36 mins ago
Associate Director, Technical Project Management
Braven
Remote, United States
…Project Management. This role will serve as a technical project manager for a specific domain area within the Systems Team, ensuring a standard project management methodology is embedded…
Added 36 mins ago
Associate Director, Technical Project Management
Braven
Remote, United States
…Project Management. This role will serve as a technical project manager for a specific domain area within the Systems Team, ensuring a standard project management methodology is embedded…
Added 38 mins ago
TC
Traveling Project Safety Manager - MSG - Sports
Turner Construction
Denver, CO
- $40,123 USD / year
Conduct and review project team's safety audits, assess recommended corrective actions, and issue reports of violations and/or unsafe practices for immediate resolution.
Added 41 mins ago
Restaurant General Manager
Fulenwider Enterprises KFC & Taco Bell
West Jefferson, NC
…successful and happy in their work. The Restaurant General Manager plays a key role in the operation of our restaurants and has accountability for directing the daily operations of the…
Added 41 mins ago
Restaurant General Manager
Fulenwider Enterprises KFC & Taco Bell
LANDRUM, SC
…successful and happy in their work. The Restaurant General Manager plays a key role in the operation of our restaurants and has accountability for directing the daily operations of the…
Added 48 mins ago
HD-Assist General Manager
Default CKE Brand
JEFFERSON CITY, TN
The Assistant General Manager (AGM) supports the Restaurant General Manager (RGM) in directing the daily operations of a Hardee’s restaurant in support of the Brand Vision, Mission, and…

Closed listing

FORMULATED Solutions LLC

REGULATORY ADVISOR

Largo, FL, United States

This opening has closed.

The original listing is kept below for reference.

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Job details

Posting language: English

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Original job description

Archived listing. The details below describe a past opening.

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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More about this job

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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