$279K - $300K/yr
FDAMA, FD&C labelling, and OPDP guidance Labelling& FDA Liaison * Prepare and file pre-clearance materials via Form FDA 2253,leadOPDP interactions, and respond to enforcement letters/advisories
$279K - $300K/yr
FDAMA, FD&C labelling, and OPDP guidance Labelling& FDA Liaison * Prepare and file pre-clearance materials via Form FDA 2253,leadOPDP interactions, and respond to enforcement letters/advisories
$279K - $300K/yr
FDAMA, FD&C labelling, and OPDP guidance Labelling& FDA Liaison * Prepare and file pre-clearance materials via Form FDA 2253,leadOPDP interactions, and respond to enforcement letters/advisories
The Nurse Liaison role (KNL) is a field-based position comprised of nurses reporting to the Head of ... Demonstrates a working knowledge of FDA, HIPPA regulations and approved guidelines for ...
The Nurse Liaison role (KNL) is a field-based position comprised of nurses reporting to the Head of ... Demonstrates a working knowledge of FDA, HIPPA regulations and approved guidelines for ...
Job Title Medical Science Liaison - MidAtlantic/Northeast Requisition JR000015725 Medical Science ... Ensure appropriate communication of clinical and scientific information regarding FDA approved and ...
Job Title Medical Science Liaison - MidAtlantic/Northeast Requisition JR000015725 Medical Science ... Ensure appropriate communication of clinical and scientific information regarding FDA approved and ...
$143K - $188K/yr
Our flagship product, PROVENGE ® (sipuleucel-T) , was the first FDA-approved immunotherapy for ... The Dendreon Medical Science Liaison is a credentialed therapeutic and disease state expert who ...
$143K - $188K/yr
Our flagship product, PROVENGE ® (sipuleucel-T) , was the first FDA-approved immunotherapy for ... The Dendreon Medical Science Liaison is a credentialed therapeutic and disease state expert who ...
Job Title Medical Science Liaison - MidAtlantic/Northeast Requisition JR000015725 Medical Science ... Ensure appropriate communication of clinical and scientific information regarding FDA approved and ...
Job Title Medical Science Liaison - MidAtlantic/Northeast Requisition JR000015725 Medical Science ... Ensure appropriate communication of clinical and scientific information regarding FDA approved and ...
$143K - $188K/yr
Our flagship product, PROVENGE ® (sipuleucel-T) , was the first FDA-approved immunotherapy for ... The Dendreon Medical Science Liaison is a credentialed therapeutic and disease state expert who ...
$143K - $188K/yr
Our flagship product, PROVENGE ® (sipuleucel-T) , was the first FDA-approved immunotherapy for ... The Dendreon Medical Science Liaison is a credentialed therapeutic and disease state expert who ...
Our flagship product, PROVENGE (sipuleucel-T) , was the first FDA-approved immunotherapy for ... The Dendreon Medical Science Liaison is a credentialed therapeutic and disease state expert who ...
Our flagship product, PROVENGE (sipuleucel-T) , was the first FDA-approved immunotherapy for ... The Dendreon Medical Science Liaison is a credentialed therapeutic and disease state expert who ...
Our flagship product, PROVENGE (sipuleucel-T) , was the first FDA-approved immunotherapy for ... The Dendreon Medical Science Liaison is a credentialed therapeutic and disease state expert who ...
Our flagship product, PROVENGE (sipuleucel-T) , was the first FDA-approved immunotherapy for ... The Dendreon Medical Science Liaison is a credentialed therapeutic and disease state expert who ...
Ann Arbor, MI · On-site
... serving as the liaison between Wacker and our Canadian Regulatory Agent * Work with other ... Will interpret FDA regulations and utilizing government and 3rd party databases such as the FDA ...
Ann Arbor, MI · On-site
... serving as the liaison between Wacker and our Canadian Regulatory Agent * Work with other ... Will interpret FDA regulations and utilizing government and 3rd party databases such as the FDA ...
Florham Park, NJ · On-site
$145K - $1M/yr
The Medical Science Liaison (MSL) delivers accurate, balanced, and unbiased scientific information ... Working knowledge of FDA and OIG regulations, as well as clinical trial design and statistical ...
Florham Park, NJ · On-site
$145K - $1M/yr
The Medical Science Liaison (MSL) delivers accurate, balanced, and unbiased scientific information ... Working knowledge of FDA and OIG regulations, as well as clinical trial design and statistical ...
Princeton, NJ · On-site +1
$165K - $220K/yr
View More Jobs Medical Science Liaison, Rheumatology Northeast Princeton, NJ, United States (Remote ... Working knowledge of FDA and OIG requirements as well as clinical trial design and statistics is ...
Princeton, NJ · On-site +1
$165K - $220K/yr
View More Jobs Medical Science Liaison, Rheumatology Northeast Princeton, NJ, United States (Remote ... Working knowledge of FDA and OIG requirements as well as clinical trial design and statistics is ...
Gaithersburg, MD · Hybrid
$124K - $155K/yr
Recent FDA-related experience is required. This is a hybrid position, which includes a3-day on-site ... Serve as a liaison between business, data, and technical teams, ensuring alignment and effective ...
Gaithersburg, MD · Hybrid
$124K - $155K/yr
Recent FDA-related experience is required. This is a hybrid position, which includes a3-day on-site ... Serve as a liaison between business, data, and technical teams, ensuring alignment and effective ...
Serve as the primary liaison between business stakeholders, technical teams, and federal clients ... Extensive experience in FDA-regulated environments. * Proven success in leading organizational ...
Serve as the primary liaison between business stakeholders, technical teams, and federal clients ... Extensive experience in FDA-regulated environments. * Proven success in leading organizational ...
Falls Church, VA · Hybrid
$124K - $155K/yr
Recent FDA-related experience is required. This is a hybrid position, which includes a3-day on-site ... Serve as a liaison between business, data, and technical teams, ensuring alignment and effective ...
Falls Church, VA · Hybrid
$124K - $155K/yr
Recent FDA-related experience is required. This is a hybrid position, which includes a3-day on-site ... Serve as a liaison between business, data, and technical teams, ensuring alignment and effective ...
Serve as the primary liaison between business stakeholders, technical teams, and federal clients ... Extensive experience in FDA-regulated environments. * Proven success in leading organizational ...
Quick apply
Serve as the primary liaison between business stakeholders, technical teams, and federal clients ... Extensive experience in FDA-regulated environments. * Proven success in leading organizational ...
Senior Medical Science Liaison, Cardiovascular (West) Serving as a field-based extension of the ... FDA promotional guidelines, regulations, and ethical guidelines is preferred. * Demonstrated ...
Senior Medical Science Liaison, Cardiovascular (West) Serving as a field-based extension of the ... FDA promotional guidelines, regulations, and ethical guidelines is preferred. * Demonstrated ...
Senior Medical Science Liaison, Cardiovascular (East) Serving as a field-based extension of the ... FDA promotional guidelines, regulations, and ethical guidelines is preferred. * Demonstrated ...
Senior Medical Science Liaison, Cardiovascular (East) Serving as a field-based extension of the ... FDA promotional guidelines, regulations, and ethical guidelines is preferred. * Demonstrated ...
Senior Medical Science Liaison, Cardiovascular (East) Serving as a field-based extension of the ... FDA promotional guidelines, regulations, and ethical guidelines is preferred. * Demonstrated ...
Senior Medical Science Liaison, Cardiovascular (East) Serving as a field-based extension of the ... FDA promotional guidelines, regulations, and ethical guidelines is preferred. * Demonstrated ...
Senior Medical Science Liaison, Cardiovascular (West) Serving as a field-based extension of the ... FDA promotional guidelines, regulations, and ethical guidelines is preferred. * Demonstrated ...
Senior Medical Science Liaison, Cardiovascular (West) Serving as a field-based extension of the ... FDA promotional guidelines, regulations, and ethical guidelines is preferred. * Demonstrated ...
Serve as the primary liaison between business stakeholders, technical teams, and federal clients ... Extensive experience in FDA-regulated environments. * Proven success in leading organizational ...
Serve as the primary liaison between business stakeholders, technical teams, and federal clients ... Extensive experience in FDA-regulated environments. * Proven success in leading organizational ...
$10.82 - $13.81
1% of jobs
$13.81 - $16.81
11% of jobs
$18.71 is the 25th percentile. Wages below this are outliers.
$16.81 - $19.80
21% of jobs
$19.80 - $22.79
17% of jobs
The median wage is $22.89 / hr.
$22.79 - $25.79
17% of jobs
$28.53 is the 75th percentile. Wages above this are outliers.
$25.79 - $28.78
9% of jobs
$28.78 - $31.77
7% of jobs
$31.77 - $34.77
5% of jobs
$34.77 - $37.76
5% of jobs
$37.76 - $40.76
4% of jobs
$40.76 - $43.75
2% of jobs
$10
$25
$43
| Aspect | Fda Liaison | Regulatory Affairs Specialist |
|---|---|---|
| Required Credentials | Bachelor's degree, knowledge of FDA regulations | Bachelor's degree, often advanced certifications in regulatory affairs |
| Work Environment | Collaborates with FDA officials, industry meetings | Prepares regulatory submissions, interacts with internal teams |
| Employer & Industry Usage | Pharmaceutical, biotech companies, medical device firms | Pharmaceutical, biotech, medical device sectors |
| Common Search & Comparison | Focuses on FDA interactions and compliance | Focuses on regulatory strategy and documentation |
The main difference between an Fda Liaison and a Regulatory Affairs Specialist lies in their primary focus. An Fda Liaison primarily interacts directly with the FDA to ensure compliance and facilitate communication, while a Regulatory Affairs Specialist manages regulatory submissions and strategies within the company. Both roles require knowledge of FDA regulations and often overlap in industry settings, but their day-to-day responsibilities and interactions differ.
$279K - $300K/yr
Full-time
Medical, Dental, Vision, Retirement
Posted 21 days ago
Join Immatics and shape the future of cancer immunotherapy; one patient at a time!
Immatics is committed to making a meaningful impact on the lives of patients with cancer. We are the global leader in precision targeting of PRAME, a target expressed in more than 50 cancers. Our cutting-edge science and robust clinical pipeline form the broadest PRAME franchise with the most PRAME indications and modalities, spanning TCR T-cell therapies and TCR bispecifics.
Why Join Us?
Innovative Environment: Help pioneer advancements in cancer immunotherapy
Collaborative Culture: Be part of a diverse team dedicated to your professional growth
Global Impact:Contribute to therapies that make a lasting impact on patients globally
Role Overview
We are seeking a Senior Director, Regulatory Affairs Advertising & Promotionto support our Regulatory Affairsteam. The Senior Director will be responsible for Serving as the primary U.S Regulatory expert for promotional materials through Immatics' pipeline and any future commercial launches.
Schedule: 8:00 AM - 5:00 PM; Monday to Friday
Reports to: Global Head of Regulatory Affairs
Location: Fully Remote
Salary Range: $279,000 - $300,000
Basic Qualifications:
Bachelorsin Life Sciences, Pharmacy, Regulatory Affairs
12+ yearsin pharma/biotech Regulatory Affairs with Advertising/Promotion focusincluding leadership responsibility
Provenexpertisein FDA-regulated promotional compliance, COP/OPDP, and PI/label negotiations
Comprehensive knowledge of FDCA, OPDP, FDAMA, PDMA, PhRMA Code, scientific exchange, misbranding, and fair balance
Preferred Qualifications:
Advanced degree (PharmD, JD, MS) in Life Sciences, Pharmacy, Regulatory Affairs
RA Certification (RAC)
Knowledge of global promotional regulationswould be a plus
In this role you will:
Strategic Regulatory Leadership
Chairandlead PRC, ensuring "fair balance," alignment with Prescribing Information (PI), and compliance with scientific exchange and misbranding rules
Ensure U.S advertising and promotional strategy consistency with FDCA. FDAMA, FD&C labelling, and OPDP guidance
Labelling& FDA Liaison
Prepare and file pre-clearance materials via Form FDA 2253,leadOPDP interactions, and respond to enforcement letters/advisories
Support label negotiations for PI, carton/container, and PPI
Promotional Compliance Oversight
Review advertising copy, promotional claims, speaker programs, digital/social media materials, and HCP-facing promotions for FDA compliance
Identifyand remediate claims, manage recall and mitigation activities when necessary
Team Leadership &BudgetManagement
Mentor junior RA professionals; oversee operational delivery and resource allocation
Manage budget for Ad/Promo activities and ensure cohesive execution across programs
Travel required: Occasional domestic or international travel
Qualified candidates will participate in a structured interview process, which includes:
An initial recruiter phone screen (conducted via video)
A recruiter-facilitated introduction and interview with the hiring leader and key stakeholders (via video)
A final-stage interview, which may include an in-person meeting at our U.S. Headquarters in Houston, TX
What do we offer?
At Immatics, we believe in investing in our team's health, safety and well-being. Here's what you can expect if you join Immatics:
Comprehensive Benefits:
Competitive rates for Health, Dental, and Vision Insurance
4 weeks of vacation granted up front each year and prorated for first and last year of employment
12 company paid holidays
7 days of sick time
100% employer-paid life insuranceup to at 1x annual salary, up to one hundred thousand dollars
100% employer-paid short- and long-Term disability coverage
401(k) with immediate eligibilityand company match
The company will match 100% of your contributions up to 3% of your base salary for the first two years of employment, 4% for years 2-3 of employment, and up to 5% of your salary from the fourth year onward of continued employment
Partially paid parental leavefor eligible employees
Additional voluntary employee-paid benefits and services, including accident, hospital indemnity, and critical illness insurance, as well as identity theft protection and pet insurance
Equal Employment Opportunity
We are an equal opportunity employer and are committed to building a diverse and inclusive workplace. We consider all qualified applicants for employment without regard torace, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexualorientation, gender identity or expression, national origin, ancestry, age, marital status, disability, geneticinformation, veteran status, or any other status protected by applicable law.
Reasonable Accommodations
We are committed to providing reasonable accommodations to individuals with disabilities and to applicants withsincerely heldreligious beliefs, practices, or observances. If you require assistance or accommodation during the application or interview process, please contact us atRecruitingUS@immatics.com.
Work Authorization
Applicants mustbe authorized towork in the United States without the need for current or future sponsorship. Visa sponsorships may beavailablefor certain roles.
Pre-Employment Requirements
Employment is contingent upon successful completion of a background check, referencechecksand pre-employment drug screening, wherepermittedby applicable law. For certain roles,additionalscreenings such as a credit check or motor vehicle record review may berequired, where job-related and consistent with business necessity.