Remote opportunity at
Kyverna TherapeuticsAssociate Director, Regulatory Affairs, Advertising, Promotion & Labeling
Kyverna Therapeutics seeks an Associate Director for Regulatory Affairs, Advertising, Promotion & Labeling to guide product communications and core labeling throughout the product lifecycle, from pre-launch…
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About This Role
Kyverna Therapeutics seeks an Associate Director for Regulatory Affairs, Advertising, Promotion & Labeling to guide product communications and core labeling throughout the product lifecycle, from pre-launch planning onward. This remote position prefers candidates working on West Coast hours and requires up to 20% travel. The selected professional will act as the primary regulatory authority on promotional and medical review committees, supply risk-based advice regarding claims and fair balance, and direct…
Job Description
Kyverna Therapeutics seeks an Associate Director for Regulatory Affairs, Advertising, Promotion & Labeling to guide product communications and core labeling throughout the product lifecycle, from pre-launch planning onward. This remote position prefers candidates working on West Coast hours and requires up to 20% travel. The selected professional will act as the primary regulatory authority on promotional and medical review committees, supply risk-based advice regarding claims and fair balance, and direct engagements with the US FDA Office of Prescription Drug Promotion. Additionally, the role involves managing labeling negotiations with health authorities, collaborating with global regulatory teams, and creating standard operating procedures. This opportunity suits an experienced regulatory expert with a background in biopharmaceuticals who can lead cross-functional teams across commercial, medical affairs, legal, and compliance departments to meet business goals while maintaining adherence to global regulations.
Responsibilities
- Function as the regulatory lead for promotional and medical review committees to offer risk-based counsel on claims and fair balance.
- Supply proactive regulatory guidance for promotional, advertising, and educational materials across all delivery channels.
- Lead communications with the US FDA Office of Prescription Drug Promotion and the Advertising and Promotional Labeling Branch.
- Work with Global Regulatory Leads on health authority labeling negotiations to support commercialization goals.
- Direct the creation, maintenance, and global implementation of core, United States, and patient product labeling.
- Design and enhance review procedures, standard operating procedures, training programs, and internal systems.
- Formulate and carry out global labeling strategies to incorporate updated safety and efficacy data.
- Track regulatory shifts, competitor activities, and enforcement trends to advise leadership and update internal policies.
- Supervise external vendors while managing assigned resources and budgets.
- Partner with commercial, medical affairs, legal, and compliance units to guarantee communications align with approved labeling and regulations.
Requirements
- Minimum of 8 years of regulatory experience within the biopharmaceutical sector.
- At least 6 years of direct experience in advertising and promotion or an equivalent capacity.
- Demonstrated knowledge of FDA promotional rules, product labeling, medical-legal-regulatory reviews, and OPDP interactions.
- Track record of managing product launches and handling lifecycle management tasks.
- Proficiency with Veeva PromoMats or comparable software systems.
Qualifications
- Bachelor of Science or Master of Science degree with relevant industry experience.
- Advanced life sciences or medical degree such as an MD, PhD, or PharmD.
- Growth-stage biotechnology company work history.
Core Skills
Benefits
- Annual bonus eligibility
- Equity awards
- Participation in the company stock plan
- Standard company benefits
Frequently Asked Questions
Answers are based only on the employer’s listing; where it doesn’t say, neither do we.
What is the location and work arrangement for this role?
The position is remote, though West Coast working hours are preferred, and requires approximately 20% travel.
What is the salary range for the Associate Director position?
The national annual salary range is estimated between $180,000 and $205,000, depending on factors such as experience, education, geographic location, market data, and internal equity.
What experience is required to apply?
Candidates must have 8 or more years of biopharmaceutical regulatory experience, which includes at least 6 years focused on advertising and promotion or equivalent tasks.
What additional compensation is offered beyond the base salary?
The role is eligible for an annual bonus, equity, company benefits, and participation in the corporate stock plan.
Sample Interview Questions
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