Gilead Sciences
Manager, Regulatory Affairs Advertising and Promotion
Gilead Sciences, San Mateo, California, United States, 94409
Manager, Regulatory Affairs Advertising and Promotion
Join to apply for the
Manager, Regulatory Affairs Advertising and Promotion
role at
Gilead Sciences Manager, Regulatory Affairs Advertising and Promotion
1 day ago Be among the first 25 applicants Join to apply for the
Manager, Regulatory Affairs Advertising and Promotion
role at
Gilead Sciences Get AI-powered advice on this job and more exclusive features. At Gilead, were creating a healthier world for all people. For more than 35 years, weve tackled diseases such as HIV, viral hepatitis, COVID-19 and cancer working relentlessly to develop therapies that help improve lives and to ensure access to these therapies across the globe. We continue to fight against the worlds biggest health challenges, and our mission requires collaboration, determination and a relentless drive to make a difference.
Every member of Gileads team plays a critical role in the discovery and development of life-changing scientific innovations. Our employees are our greatest asset as we work to achieve our bold ambitions, and were looking for the next wave of passionate and ambitious people ready to make a direct impact.
We believe every employee deserves a great leader. People Leaders are the cornerstone to the employee experience at Gilead and Kite. As a people leader now or in the future, you are the key driver in evolving our culture and creating an environment where every employee feels included, developed and empowered to fulfil their aspirations. Join Gilead and help create possible, together.
Job Description
Regulatory Advertising and Promotion (RA Ad/Promo) is a core function within Gilead's Global Regulatory Affairs organization and acts as a critical strategic partner across cross-functional teams. RA Ad/Promo provides strategic regulatory guidance and input on Gilead's commercial and corporate communications, and plays a critical role ensuring that these activities are compliant with governing laws, regulations, and Gilead policies and procedures, while enabling the business to compliantly meet its goals and objectives. This group also represents Gilead's commercial activities to U.S. regulatory agencies.
You will provide commercial regulatory support for assigned brands, therapeutic area, and other projects. You may review and approve or co-review/approve promotional materials. You may manage external operational contractor support, including advising on OPDP submission requirements for accelerated approval and launch submissions, as applicable. You may initiate and/or contribute to local process improvements for activities relating to the work of RA Ad/Promo.
You may train cross-functional partners and teams on promotional material submission requirements. You will assist or serve as the Promotional Review Committee (PRC) Chair for one or more brands or therapeutic areas. With management oversight, you will provide regulatory guidance on new promotional concepts and campaigns. You may represent RA Ad/Promo in Regulatory Project Teams. You may also attend labeling meetings.
Example Responsibilities
Provides commercial regulatory support to assigned products or therapeutic area and projects with managerial oversight, as appropriate. Conducts co-review and/or review and approval of promotional materials. May train external contractors on Gilead submission processes and advise on submission requirements for promotional materials, including accelerated approval and launch submissions. May manage external operational contractors, as necessary. May serve as group lead for external operational contractor support, including managing division of responsibilities and coverage plans. Provides training to cross-functional team members on promotional material submission requirements, as needed. Assists or serves as PRC Chair for one or more brands or therapeutic areas. Maintains a continued awareness and understanding of FDA regulations, guidance documents, and enforcement actions with regards to advertising and promotion of pharmaceutical products. May initiate and/or contribute to local process improvements for activities that relate to regulatory advertising/promotion. May provide regulatory guidance on new marketing concepts, messages, and campaigns with managerial oversight. Represents RA Ad/Promo at Regulatory Project Team meetings as needed. May attend labeling meetings as needed, with managerial oversight. Seeks assistance from others as needed. Supports and helps coordinate the training of new Associates in the Regulatory Ad/Promo group, as needed. Ensures own work complies with established practices, policies, and processes, and any regulatory or other requirements.
Requirements
We are all different, yet we all use our unique contributions to serve patients. Please see the following for the qualifications and skills we seek for this role.
Education & Experience
PharmD/PhD with some relevant experience. MA/MS/MBA with 4+years relevant experience. BA/BS with 6+ years relevant experience. For external candidates, 1+ years experience in regulatory review of promotions for prescription drugs or other biologic products. Experience leading development and execution of regulatory submissions of promotional materials for prescription drug or biologic products is preferred. Experience working with external operational contractors supporting the work of regulatory affairs is a plus. Experience writing or updating processes. Experience working in project teams.
Knowledge & Other Requirements
Demonstrated ability to be a fast learner. Demonstrated ability to be flexible and adaptable to change, to move between projects easily and provide support/expertise where needed. Demonstrates working knowledge of the role of regulatory affairs in achieving cross-functional business goals and objectives. Knowledge of regulatory requirements and guidance for the promotion of prescription drug and biologic products. Working knowledge of relevant regulatory or related systems is preferred. Demonstrates strong analytical thinking skills, attention-to-detail, strong communication and writing skills, and project management skills, as evidenced through accomplishments in past roles. Ability to lead and influence programs, projects and/or initiatives. Strong interpersonal skills and understanding of team dynamics. Proven ability to work successfully in a team-oriented, highly matrixed environment. When needed, ability to travel.
The Salary Range For This Position Is
Bay Area: $146,540.00 - $189,640.00.
Other US Locations: $133,195.00 - $172,370.00.
Gilead considers a variety of factors when determining base compensation, including experience, qualifications, and geographic location. These considerations mean actual compensation will vary. This position may also be eligible for a discretionary annual bonus, discretionary stock-based long-term incentives (eligibility may vary based on role), paid time off, and a benefits package. Benefits include company-sponsored medical, dental, vision, and life insurance plans*.
For Additional Benefits Information, Visit
https://www.gilead.com/careers/compensation-benefits-and-wellbeing
Eligible employees may participate in benefit plans, subject to the terms and conditions of the applicable plans.
For Jobs In The United States
Gilead Sciences Inc. is committed to providing equal employment opportunities to all employees and applicants for employment, and is dedicated to fostering an inclusive work environment comprised of diverse perspectives, backgrounds, and experiences. Employment decisions regarding recruitment and selection will be made without discrimination based on race, color, religion, national origin, sex, age, sexual orientation, physical or mental disability, genetic information or characteristic, gender identity and expression, veteran status, or other non-job related characteristics or other prohibited grounds specified in applicable federal, state and local laws. In order to ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Era Veterans' Readjustment Act of 1974, and Title I of the Americans with Disabilities Act of 1990, applicants who require accommodation in the job application process may contact ApplicantAccommodations@gilead.com for assistance.
For more information about equal employment opportunity protections, please view the 'Know Your Rights' poster.
NOTICE: EMPLOYEE POLYGRAPH PROTECTION ACT
YOUR RIGHTS UNDER THE FAMILY AND MEDICAL LEAVE ACT
PAY TRANSPARENCY NONDISCRIMINATION PROVISION
Our environment respects individual differences and recognizes each employee as an integral member of our company. Our workforce reflects these values and celebrates the individuals who make up our growing team.
Gilead provides a work environment free of harassment and prohibited conduct. We promote and support individual differences and diversity of thoughts and opinion.
For Current Gilead Employees And Contractors
Please apply via the Internal Career Opportunities portal in Workday.
Seniority level
Seniority level
Not Applicable Employment type
Employment type
Full-time Job function
Job function
Legal Industries
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Join to apply for the
Manager, Regulatory Affairs Advertising and Promotion
role at
Gilead Sciences Manager, Regulatory Affairs Advertising and Promotion
1 day ago Be among the first 25 applicants Join to apply for the
Manager, Regulatory Affairs Advertising and Promotion
role at
Gilead Sciences Get AI-powered advice on this job and more exclusive features. At Gilead, were creating a healthier world for all people. For more than 35 years, weve tackled diseases such as HIV, viral hepatitis, COVID-19 and cancer working relentlessly to develop therapies that help improve lives and to ensure access to these therapies across the globe. We continue to fight against the worlds biggest health challenges, and our mission requires collaboration, determination and a relentless drive to make a difference.
Every member of Gileads team plays a critical role in the discovery and development of life-changing scientific innovations. Our employees are our greatest asset as we work to achieve our bold ambitions, and were looking for the next wave of passionate and ambitious people ready to make a direct impact.
We believe every employee deserves a great leader. People Leaders are the cornerstone to the employee experience at Gilead and Kite. As a people leader now or in the future, you are the key driver in evolving our culture and creating an environment where every employee feels included, developed and empowered to fulfil their aspirations. Join Gilead and help create possible, together.
Job Description
Regulatory Advertising and Promotion (RA Ad/Promo) is a core function within Gilead's Global Regulatory Affairs organization and acts as a critical strategic partner across cross-functional teams. RA Ad/Promo provides strategic regulatory guidance and input on Gilead's commercial and corporate communications, and plays a critical role ensuring that these activities are compliant with governing laws, regulations, and Gilead policies and procedures, while enabling the business to compliantly meet its goals and objectives. This group also represents Gilead's commercial activities to U.S. regulatory agencies.
You will provide commercial regulatory support for assigned brands, therapeutic area, and other projects. You may review and approve or co-review/approve promotional materials. You may manage external operational contractor support, including advising on OPDP submission requirements for accelerated approval and launch submissions, as applicable. You may initiate and/or contribute to local process improvements for activities relating to the work of RA Ad/Promo.
You may train cross-functional partners and teams on promotional material submission requirements. You will assist or serve as the Promotional Review Committee (PRC) Chair for one or more brands or therapeutic areas. With management oversight, you will provide regulatory guidance on new promotional concepts and campaigns. You may represent RA Ad/Promo in Regulatory Project Teams. You may also attend labeling meetings.
Example Responsibilities
Provides commercial regulatory support to assigned products or therapeutic area and projects with managerial oversight, as appropriate. Conducts co-review and/or review and approval of promotional materials. May train external contractors on Gilead submission processes and advise on submission requirements for promotional materials, including accelerated approval and launch submissions. May manage external operational contractors, as necessary. May serve as group lead for external operational contractor support, including managing division of responsibilities and coverage plans. Provides training to cross-functional team members on promotional material submission requirements, as needed. Assists or serves as PRC Chair for one or more brands or therapeutic areas. Maintains a continued awareness and understanding of FDA regulations, guidance documents, and enforcement actions with regards to advertising and promotion of pharmaceutical products. May initiate and/or contribute to local process improvements for activities that relate to regulatory advertising/promotion. May provide regulatory guidance on new marketing concepts, messages, and campaigns with managerial oversight. Represents RA Ad/Promo at Regulatory Project Team meetings as needed. May attend labeling meetings as needed, with managerial oversight. Seeks assistance from others as needed. Supports and helps coordinate the training of new Associates in the Regulatory Ad/Promo group, as needed. Ensures own work complies with established practices, policies, and processes, and any regulatory or other requirements.
Requirements
We are all different, yet we all use our unique contributions to serve patients. Please see the following for the qualifications and skills we seek for this role.
Education & Experience
PharmD/PhD with some relevant experience. MA/MS/MBA with 4+years relevant experience. BA/BS with 6+ years relevant experience. For external candidates, 1+ years experience in regulatory review of promotions for prescription drugs or other biologic products. Experience leading development and execution of regulatory submissions of promotional materials for prescription drug or biologic products is preferred. Experience working with external operational contractors supporting the work of regulatory affairs is a plus. Experience writing or updating processes. Experience working in project teams.
Knowledge & Other Requirements
Demonstrated ability to be a fast learner. Demonstrated ability to be flexible and adaptable to change, to move between projects easily and provide support/expertise where needed. Demonstrates working knowledge of the role of regulatory affairs in achieving cross-functional business goals and objectives. Knowledge of regulatory requirements and guidance for the promotion of prescription drug and biologic products. Working knowledge of relevant regulatory or related systems is preferred. Demonstrates strong analytical thinking skills, attention-to-detail, strong communication and writing skills, and project management skills, as evidenced through accomplishments in past roles. Ability to lead and influence programs, projects and/or initiatives. Strong interpersonal skills and understanding of team dynamics. Proven ability to work successfully in a team-oriented, highly matrixed environment. When needed, ability to travel.
The Salary Range For This Position Is
Bay Area: $146,540.00 - $189,640.00.
Other US Locations: $133,195.00 - $172,370.00.
Gilead considers a variety of factors when determining base compensation, including experience, qualifications, and geographic location. These considerations mean actual compensation will vary. This position may also be eligible for a discretionary annual bonus, discretionary stock-based long-term incentives (eligibility may vary based on role), paid time off, and a benefits package. Benefits include company-sponsored medical, dental, vision, and life insurance plans*.
For Additional Benefits Information, Visit
https://www.gilead.com/careers/compensation-benefits-and-wellbeing
Eligible employees may participate in benefit plans, subject to the terms and conditions of the applicable plans.
For Jobs In The United States
Gilead Sciences Inc. is committed to providing equal employment opportunities to all employees and applicants for employment, and is dedicated to fostering an inclusive work environment comprised of diverse perspectives, backgrounds, and experiences. Employment decisions regarding recruitment and selection will be made without discrimination based on race, color, religion, national origin, sex, age, sexual orientation, physical or mental disability, genetic information or characteristic, gender identity and expression, veteran status, or other non-job related characteristics or other prohibited grounds specified in applicable federal, state and local laws. In order to ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Era Veterans' Readjustment Act of 1974, and Title I of the Americans with Disabilities Act of 1990, applicants who require accommodation in the job application process may contact ApplicantAccommodations@gilead.com for assistance.
For more information about equal employment opportunity protections, please view the 'Know Your Rights' poster.
NOTICE: EMPLOYEE POLYGRAPH PROTECTION ACT
YOUR RIGHTS UNDER THE FAMILY AND MEDICAL LEAVE ACT
PAY TRANSPARENCY NONDISCRIMINATION PROVISION
Our environment respects individual differences and recognizes each employee as an integral member of our company. Our workforce reflects these values and celebrates the individuals who make up our growing team.
Gilead provides a work environment free of harassment and prohibited conduct. We promote and support individual differences and diversity of thoughts and opinion.
For Current Gilead Employees And Contractors
Please apply via the Internal Career Opportunities portal in Workday.
Seniority level
Seniority level
Not Applicable Employment type
Employment type
Full-time Job function
Job function
Legal Industries
Biotechnology Research and Pharmaceutical Manufacturing Referrals increase your chances of interviewing at Gilead Sciences by 2x Get notified about new Regulatory Affairs Manager jobs in
Foster City, CA . Quality Assurance & Regulatory Affairs Manager
San Francisco, CA $100,000.00-$150,000.00 6 months ago Sr Regulatory Affairs Specialist (Remote) - Shockwave
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Santa Clara, CA $89,000.00-$165,600.00 15 hours ago San Francisco, CA $100,000.00-$150,000.00 6 months ago Sunnyvale, CA $80,000.00-$140,000.00 7 months ago Senior Manager, Renewables Regulatory NERC & Operational Compliance
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Senior Regulatory Affairs Specialist -Vascular (on-site)
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Santa Clara, CA $112,000.00-$224,000.00 1 month ago Regulatory Affairs Manager Canada & Latin America Diabetes Care (on-site)
Alameda, CA $112,000.00-$224,000.00 3 weeks ago Senior Regulatory Affairs Specialist (NMPA Green Channel Submission)
Sunnyvale, CA $119,900.00-$203,000.00 1 week ago Were unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI. #J-18808-Ljbffr