Top 581 Regulatory affairs Jobs in Remote

Director, Regulatory Affairs Advertising and Promotion
Ultragenyx Pharmaceutical —Novato, CA
- $214,100 - $264,500 a year
- Full-time
- Remote
- 5 years
- Bachelor of Science
- Bachelor's degree
- Gym membership
14d
Regulatory Affairs Specialist
Medline Industries —Remote
- $79,000 - $119,000 a year
- Full-time
- Remote
- Bachelor of Science
- Mid-level
- Travel
- Health insurance
- 401(k)
Senior Regulatory Affairs Specialist
Saluda Medical —Remote
- Full-time
- Remote
- Analysis skills
- Mentoring
- Senior level
Quick Apply
Regulatory Affairs Consultant
Edison Scientific —Remote
- $200 - $400 an hour
- Contract
- Remote
- Psychiatry
- Bachelor's degree
- Senior level
- Commuter assistance
- Paid parental leave
Associate Regulatory Affairs Labeling Associate
Civica Rx —Remote
- Remote
- Mid-level
- Bachelor's degree
- Continuous improvement
Senior Regulatory Affairs Specialist
Siemens Healthineers —Remote
- $117,770 - $161,931 a year
- Full-time
- Remote
- Microsoft Outlook
- Mid-level
- Presentation skills
- Disability insurance
- Health insurance
Quick Apply
12d
Regulatory Affairs Specialist
Scale Media —Remote
- $75,000 - $85,000 a year
- Full-time
- Mid-level
- Bachelor's degree
- 2 years
- Health insurance
- Dental insurance
Quick Apply
8d
Senior Regulatory Affairs Specialist
Oura —Remote
- $127,500 - $178,000 a year
- Remote
- 5 years
- Organizational skills
- Senior level
- Paid holidays
- Health insurance
6d
Analyst, Regulatory Affairs
Oscar Health —Atlanta, GA
- $28.30 - $37.15 an hour
- Overtime
- Remote
- Mid-level
- Microsoft Office
- Bachelor's degree
- Paid parental leave
- Paid holidays
Quick Apply
Head of Regulatory Affairs
Revolut —Remote
- $207,000 - $217,900 a year
- Full-time
- Remote
- Supervising experience
- Senior level
- Communication skills
Quality and Regulatory (QA/RA) Consultant - Independent Contractor
Cook Device Solutions —Remote
- $100 - $175 an hour
- Part-time
- Remote
- Computer literacy
- Bachelor's degree
- Travel
- Flexible schedule
Quick Apply
12d
Principal Regulatory Affairs Specialist
Saluda Medical —Remote
- Full-time
- Remote
- 7 years
- Microsoft Excel
- Analysis skills
Quick Apply
Regulatory Affairs Specialist — Medical Devices
Azaaki LLC —Remote
- $85 - $90 an hour
- Full-time
- Remote
- Background check
- 5 years
- Engineering
- Work from home
Quick Apply
7d
Senior Regulatory Affairs Consultant
ProductLife Group —Remote
- $160,000 - $190,000 a year
- Bachelor of Science
- Bachelor's degree
- Mentoring
Senior Associate Specialist, Regulatory Operations
Loyal —Remote
- $110,000 - $160,000 a year
- Remote
- Mid-level
- 3 years
- Bachelor's degree
- Paid holidays
- Health insurance
14d
Senior Regulatory Affairs Associate - Generalist
Parexel —Remote
- Remote
- Writing skills
- 3 years
- Bachelor's degree
Regulatory Affairs Manager
Peterson Projects & Solutions North America —Remote
- $120,000 - $150,000 a year
- Full-time
- Spanish
- 5 years
- English
- 401(k) matching
Quick Apply
Regulatory Affairs Specialist II - Labeling & Promotion
Alora Pharmaceuticals —Alpharetta, GA
- Weekends as needed
- Remote
- Mid-level
- Office
- 3 years
13d
Amazon Compliance Specialist
Kitsch LLC —Remote
- Full-time
- Remote
- Mid-level
- 3 years
- Training & development
Sr. Manager, Regulatory Affairs
Vaxcyte —Remote
- $183,000 - $194,000 a year
- Remote
- Bachelor of Science
- Bachelor's degree
- Computer skills

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Director, Regulatory Affairs Advertising and Promotion

Ultragenyx Pharmaceutical -
Novato, CA

Apply Now

Job Details

Full-time
$214,100 - $264,500 a year
14 days ago

Benefits

Gym membership

Qualifications

Committee work
Bachelor's degree

Full Job Description

Why Join Us?

Be a hero for our rare disease patients

At Ultragenyx, we fundamentally believe that taking real impactful action to care for the needs of patients and our people is always the right thing to do. To achieve this goal, our vision is to lead the future of rare disease medicine. For us, this means going where other biopharma companies won't go – challenging the status quo and creating a new model that advances our field so more patients and caregivers can benefit from life-changing treatments. We do this by following the science, applying a novel rapid development approach, making innovative medicines at fair and reasonable prices, and creating a collaborative ecosystem to reach patients in ways that are most meaningful for them.

Our commitment and care for patients extends to our people, so culture is an essential cornerstone for Ultragenyx. We remain continuously focused on creating a supportive and inclusive environment of profound learning and growth – so employees can thrive in all areas of their lives, in and outside of work. Ultimately, we want to be an organization where we would be proud for our family, friends and children to work.

If you want to have a meaningful impact, do the best work of your career, and grow a lot, both professionally and personally, come join our team.

Position Summary:

ultrafocused – Work together to fearlessly uncover new possibilities

The Director of Regulatory Affairs Ad/Promo will serve as a subject matter expert for regulatory review of advertising and promotional, and non-promotional materials for the U.S. and Canada (CA) and provide regulatory leadership to the Materials Review Committee (MRC) to ensure all communications, advertising and promotional materials and programs throughout the product life cycle are compliant with applicable laws, regulations, and company policies.

Work Model:

Remote: Officially documented as working full-time from home, with travel to Ultragenyx's offices or other locations on occasion as needed.

Responsibilities:

Serve as the MRC Chair and provide direction and regulatory expertise for promotional materials, medical, and payer communications.
Serve as primary contact with the FDA (OPDP/APLB) and PAAB as needed, including responding to agency inquiries and managing company requests for advisory review of advertising and promotional material.
Review and approve Form FDA-2253 submissions.
Provide strategic and operational regulatory guidance on new concepts, campaigns, and product labeling to help ensure promotional materials are aligned with promotional regulations, corporate standards, and policies and business objectives.
Support the U.S. and CA commercial and medical teams, by participating in strategy discussions and extended team meetings and providing regulatory guidance and perspective on strategies and objectives and tactics.
Maintain current awareness of evolving agency regulations and interpretations, FDA advisory letters, enforcement letters and policy issues and trends affecting the industry; communicate significant changes in Agency perspective to relevant stakeholders.
May lead cross-functional process improvements or other special projects.
Represent Regulatory Affairs Ad/Promo at regulatory sub-team and labeling meetings; provide strategic regulatory guidance.
Other duties as required.

Requirements:

Requires a BA/BS degree; advanced degree preferred (PharmD, PhD, MS, MBA, JD).
10+ years of industry experience including 5+ years of advertising promotion experience.
Excellent verbal and written communication skills.
Attention to detail and ability to manage multiple priorities simultaneously.
Strong interpersonal skills with ability to demonstrate strategic and analytical thinking.
Demonstrate and proactively advocate working together in the spirit of transparency that encourages engagement, collaboration, and respectful interactions.
Experience chairing/leading review committees or other relevant regulatory governance committees.
Experience participating in cross-functional projects and teams.
Strong interpersonal skills and understanding of team dynamics.
Veeva PromoMats experience preferred.
When needed, ability to travel.

#LI-CS1, #LI-Remote

Full Time employees across the globe enjoy a range of benefits, including, but not limited to:

Generous vacation time and public holidays observed by the company

Volunteer days

Long term incentive and Employee stock purchase plans or equivalent offerings

Employee wellbeing benefits

Fitness reimbursement

Tuition sponsoring

Professional development plans

Benefits vary by region and country

Ultragenyx Pharmaceutical is an equal opportunity employer and prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, disability, marital and veteran status, and any other status or classification protected by applicable federal, state, and/or local laws. Reasonable accommodation will be provided for all protected statuses or classifications protected by applicable law, including individuals with disabilities, disabled veterans, for pregnancy, childbirth, and related medical conditions, and based on sincerely held religious beliefs. Applicants can request an accommodation prior to accepting a job offer. If you require reasonable accommodation in completing this application, or in any part of the recruitment process, you may contact Talent Acquisition by emailing us at [email protected].

See our CCPA Employee and Applicant Privacy Notice.

See our Privacy Policy.

It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.

Note to External Recruiters: All candidate activity and open positions are managed strictly through our Human Resources Department. Our Human Resources Department kindly requests that recruiters not contact employees/hiring managers directly in an attempt to solicit business and present candidates. Please note that failure to comply with this request will be a factor in determining a professional relationship with our organization. Submission of unsolicited resumes prior to an agreement set in place between the Human Resources Department and the recruiting agency will not create any implied obligation. Inquiries on developing a recruiting relationship with us, may be directed to: [email protected].

Apply Now

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