Top 21 Pharmatech, inc. Jobs

Regulatory Affairs Consultant, In Silico Modeling
Pharmatech Associates —Raleigh, NC
- Part-time
- Senior level
- Leadership
- 10 years
Regulatory Consultant, ANDA
Pharmatech Associates —San Francisco, CA
- Senior level
- 10 years
Process Development Consultants
Pharmatech Associates —San Francisco, CA
- Remote
- 11+ years
- English
- Master's degree
Regulatory Consultant, 505(b)(2)
Pharmatech Associates —San Francisco, CA
- Senior level
- 10 years
Manufacturing Account Planner
Pharmatech, Inc. —Lindon, UT
- $70,000 - $90,000 a year
- Full-time
- ERP systems
- Mid-level
- Analysis skills
- Paid holidays
- Health insurance
Quick Apply
Product Development Scientist
Pharmatech, Inc. —Lindon, UT
- $80,000 - $100,000 a year
- 5 years
- Bachelor's degree
- Senior level
Quick Apply
Business Development Manager- US
CRYSTAL PHARMATECH INC —Pleasanton, CA
- $85,000 - $100,000 a year
- Full-time
- Up to 50% travel
- Mid-level
- Bachelor's degree
- Health insurance
- Dental insurance
Quick Apply
Shipping & Receiving Freight Coordinator
Pharmatech, Inc. —Lindon, UT
- $50,000 - $60,000 a year
- Full-time
- ERP systems
- Mid-level
- Forklift
- Paid holidays
- Health insurance
Quick Apply
Production Packaging Operator
Pharmatech, Inc. —Lindon, UT
- $16 an hour
- Full-time
- Ability to walk for extended periods
- High school diploma or GED
- Warehouse experience
- Paid holidays
- Dental insurance
Quick Apply
11d
Production Packaging Associate
Pharmatech, Inc. —Lindon, UT
- Full-time
- High school diploma or GED
- Entry level
- Paid holidays
- Health insurance
Quick Apply
Material Handler - Warehouse - Part Time
Pharmatech, Inc. —Lindon, UT
- $18 - $20 an hour
- Part-time
- English
- Forklift
- 3 years
Quick Apply
Manufacturing- Raw Material Operator
Pharmatech, Inc. —Lindon, UT
- $16 an hour
- Full-time
- English
- High school diploma or GED
- Warehouse experience
- Paid holidays
- Dental insurance
Quick Apply
11d
Manufacturing - Compounding & Fill Operator
Pharmatech, Inc. —Lindon, UT
- $16 an hour
- Full-time
- High school diploma or GED
- Ability to lift 50 pounds
- Ability to stand for extended periods
- Paid holidays
- Dental insurance
Quick Apply
11d
Maintenance Technician - Nutritional Manufacturing
Pharmatech, Inc. —Lindon, UT
- $25 - $35 an hour
- Overtime
- Mid-level
- 3 years
- High school diploma or GED
- Paid holidays
- Health insurance
Quick Apply
Manufacturing - Blending Operator
Pharmatech, Inc. —Lindon, UT
- $17 an hour
- Full-time
- English
- High school diploma or GED
- Ability to lift 50 pounds
- Paid holidays
- Dental insurance
Quick Apply
11d
Manufacturing - Sanitation Tech
Pharmatech, Inc. —Lindon, UT
- $16 an hour
- Full-time
- Basic math
- High school diploma or GED
- Ability to lift 50 pounds
- Paid holidays
- Dental insurance
Quick Apply
11d

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Regulatory Affairs Consultant, In Silico Modeling

Pharmatech Associates -
Raleigh, NC

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Job Details

Part-time

Qualifications

FDA submissions
Investigational new drug (IND) applications
Regulatory submission editing and review
Biomedical regulatory compliance
Communication with regulatory authorities for clinical trials
Risk assessment
Audit support

Full Job Description

We are looking for a Regulatory Affairs Consultant to support several ongoing projects at about 10-20 hours per week. This role is remote.

Job Duties

Work closely with Pharmatech and our client’s executive leadership team to lead the development of regulatory strategies and objectives that result in the successful registration and post-approval commercialization of the client’s product.
Develop, lead, and drive the execution of the regulatory strategy from pre-IND to launch, commercialization and product lifecycle management
Plan and oversee activities in support of all regulatory submissions
Serve as the primary company contact with the US FDA to achieve company regulatory objectives, by fostering strong relationships and acting as a credible, reputable, and effective advocate for company
Provide regulatory guidance to the Client across all areas of regulatory affairs throughout all stages from product development
Experience working with government agencies sponsoring drugs and biologics is highly desirable. Combination Drug and Device regulatory submission experience is a plus.
Participate as part of internal regulatory team to define and execute the regulatory strategy
Support the preparation of briefing packages, and regulatory submission documents as needed , providing insight and expertise
Lead the integration of in-silico modeling and predictive modeling strategies into regulatory submissions and supporting documents for FDA review and approval.
Draft, present, and defend regulatory positions to the FDA and other global agencies, leveraging data from in-silico and predictive modeling methodologies as pivotal evidence.
Guide clients in the design and execution of in-silico and predictive modeling studies to address specific FDA concerns, including support for Q&A sessions, pre-IND, and other regulatory meetings.
Provide regulatory expertise regarding the acceptance and use of in-silico modeling outcomes in support of submissions, risk assessments, comparability protocols, and predictive stability analyses.

Education and Qualifications

Advanced degree from accredited college or university in science, biomedical engineering, plus a minimum of 10 years of experience in Filing Global Regulatory Applications for the following registrations NDA’s, ANDA’s, IND’s and BLA’s for pharmaceutical and Biotech products.
Demonstrated experience preparing briefing packages and leading regulatory defenses before the FDA where in-silico modeling and predictive analytics were significant contributors to the regulatory case.
Proven record in submission of licenses and authorizations for the maintenance of existing products; International registrations and dossiers and execution of regulatory strategies that align with business deliverables
Provide Regulatory Affairs support during internal and external audits
Plans schedules for regulatory deliverables on a project and monitors project through completion
Responsible for communicating business-related issues or opportunities to next management level

Pharmatech Associates, Inc. provides equal employment opportunity to all individuals regardless of their race, color, creed, religion, gender, age, sexual orientation, national origin, disability, veteran status, or any other characteristic protected by state, federal, or local law.

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Refine Your Search

pharmatech, inc. jobs

Regulatory Affairs Consultant, In Silico Modeling

Regulatory Consultant, ANDA

Process Development Consultants

Regulatory Consultant, 505(b)(2)

Manufacturing Account Planner

Product Development Scientist

Business Development Manager- US

Shipping & Receiving Freight Coordinator

Production Packaging Operator

Production Packaging Associate

Material Handler - Warehouse - Part Time

Manufacturing- Raw Material Operator

Manufacturing - Compounding & Fill Operator

Maintenance Technician - Nutritional Manufacturing

Manufacturing - Blending Operator

Manufacturing - Sanitation Tech

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