Director, Regulatory Affairs, Advertising/Promotion

BeOne Medicines USA, Inc.; United States; Remoto; USD 176.000 - 236.000; Tempo pieno

Descrizione del lavoro

BeOne Medicines Ltd. is seeking an experienced regulatory professional to oversee promotional and non-promotional communications for North America, reporting to the Head of Regulatory, Advertising/Promotion.

You will guide labeling strategy, collaborate with cross-functional teams including marketing, medical affairs, and legal, and ensure compliance with FDA regulations and industry codes. The role requires 10+ years in biotech/pharma, a scientific or health-related degree, and strong strategic

Competenze

• Bachelor’s degree in a scientific or health-related discipline with 10+ years in biotech/pharma.
• Minimum 5 years in regulatory advertising/promo capacity.
• Experience with FDA’s marketing/promo oversight is preferred.

Mansioni

• Oversee regulatory review of promotional materials to ensure compliance with labeling and regulations.
• Provide guidance on healthcare regulations for development and commercialization in North America.
• Lead regulatory representation on cross-functional teams for labeling, development, medical, and marketing.
• Advise on relationships with healthcare professionals and regulatory authorities as needed.
• Train on FDA and industry codes and standards applicable to promotional activities.

Conoscenze

Regulatory strategy

Cross-functional leadership

FDA experience

Oncology knowledge

Communication skills

Formazione

Bachelor’s degree in sciences/health

Strumenti

Veeva Vault

Descrizione del lavoro

BeOne continues to grow at a rapid pace with challenging and exciting opportunities for experienced professionals. When considering candidates, we look for scientific and business professionals who are highly motivated, collaborative, and most importantly, share our passionate interest in fighting cancer.

General Description: Reporting to the Head of Regulatory, Advertising/Promotion, this role provides regulatory oversight, and strategic guidance on promotional and non-promotional communications or activities for assigned BeOne marketed products in North America. This role supports our commercial, medical affairs, legal, healthcare compliance and other business functions in the United States and Canada to ensure compliance with applicable regulatory requirements and guidelines, and consistency with approved labeling.

Essential Functions of the job

Oversees the regulatory review process for promotional materials in conformance with local regulatory requirements and company policy, and to ensure consistency with approved labeling.

Provide advice and guidance on healthcare regulations applicable to the development and commercialization of BeOne’s products in North America.

Provide strategic guidance on commercial product labeling as part of the Labeling Working Group.

Serve as the lead regulatory representative on various cross-functional teams, including promotional and medical review committees.

Collaborate and participate on cross-functional teams for product labeling, product development teams, medical affairs, and marketing.

May provide advice on healthcare regulatory matters across business functions, including commercial, clinical development, medical affairs, patient safety, legal, and healthcare compliance.

Review and provide guidance on a wide range of promotional and non-promotional materials, including branded promotional materials, disease education/disease awareness campaigns, scientific communications, speaker programs, patient education materials, grants and sponsorships, training materials, and reprint and publications plans.

May provide regulatory advice on appropriate relationships with healthcare professionals, patients, managed care entities, advocacy organizations, and government entities, consistent with relevant regulations, guidance documents, and current enforcement trends.

Advise and train on the Food, Drug and Cosmetic Act, FDA guidance documents, industry codes and standards (e.g., PhRMA, ICMJE, ACCME), and other laws and regulations applicable to the development and commercialization of pharmaceutical products.

Assist with the development and implementation of policies and procedures related to healthcare compliance in the area of promotional and non-promotional communications and activities.

Liaises and negotiates with regulatory authorities as needed for all aspects pertaining to promotional activities including resolution of key regulatory issues.

Integrates functional expertise with business knowledge to solve problems and make good decisions for the overall business.

Builds partnerships with key stakeholders from other functions to ensure that strategic business goals are met through the sharing of knowledge and expertise.

Recruits, develops, manages and mentors regulatory professionals and helps create a goal-oriented culture.

Skills and Experience

• Broad and comprehensive knowledge commercial compliance requirements, including regulations and guidelines for promotional and non-promotional product communications.
• Must be capable of developing and implementing commercial regulatory strategy and managing complex negotiations with internal and external stakeholders.
• Direct experience working with FDA’s Office of Prescription Drug Promotion or Advertising and Promotional Labeling Branch is preferred.
• Oncology and/or other relevant therapeutic area experience is preferred.
• Very strong strategic skills including creativity and effectiveness in identifying and addressing major strategic challenges (e.g., new competition, shifting market environment) and the ability to balance short-term needs with long-term vision.
• Proven ability to deliver on goals within a cross-functional team/partnerenvironment with a high level of professionalism.
• Proficient ability in managing the financial and operating performance for a team.
• Excellent oral and written communication skills are a must, as are superior planning skills.
• The candidate should be detailed-oriented, a self-starter, and be comfortable with broad responsibilities in an entrepreneurial, fast-paced environment.

Education Required: Bachelor’s degree (BS/BSc or BA), preferably in a scientific or health-related discipline, 10+ years of experience in the biotech or pharmaceutical industry, and a minimum of 5 years’ experience in a Regulatory Ad/Promo capacity.

Supervisory Responsibilities: Expected to manage direct reports in the future.

Computer Skills: Proficiency in MS Office Suite applications and document management systems. Experience with using Veeva Vault preferred.

Global Competencies

• Fosters Teamwork
• Provides and Solicits Honest and Actionable Feedback
• Self-Awareness
• Acts Inclusively
• Demonstrates Initiative
• Entrepreneurial Mindset
• Continuous Learning
• Embraces Change
• Results-Oriented Analytical Thinking/Data Analysis
• Financial Excellence
• Communicates with Clarity

Salary Range: $176,000.00 - $236,000.00 annually

BeOne is committed to fair and equitable compensation practices. Actual compensation packages are determined by several factors that are unique to each candidate, including but not limited to job-related skills, depth of experience, certifications, relevant education or training, and specific work location. Packages may vary by location due to differences in the cost of labor. The recruiter can share more about the specific salary range for a preferred location during the hiring process. Please note that the listed range reflects the base salary or hourly range only. Non-Commercial roles are eligible to participate in the annual bonus plan, and Commercial roles are eligible to participate in an incentive compensation plan. All Company employees have the opportunity to own shares of BeOne Medicines Ltd. stock because all employees are eligible for discretionary equity awards and to voluntarily participate in the Employee Stock Purchase Plan. The Company has a comprehensive benefits package that includes Medical, Dental, Vision, 401(k), FSA/HSA, Life Insurance, Paid Time Off, and Wellness.

We are proud to be an equal opportunity employer. BeOne does not discriminate on the basis of race, religion, color, sex, gender identity, sexual orientation, age, disability, national origin, veteran status or any other basis covered by appropriate law. All employment is decided on the basis of qualifications, merit, and business need.

In order to ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Era Veterans’ Readjustment Assistance Act of 1974, Title I of the Americans with Disabilities Act of 1990, and any other applicable federal, state or local laws, applicants who require reasonable accommodation in the job application process may contact [e-mail].

BeOne is a global oncology company that is discovering and developing innovative treatments that are more affordable and accessible to cancer patients worldwide. With a broad portfolio, we are expediting development of our diverse pipeline of novel therapeutics through our internal capabilities and collaborations. We are committed to radically improving access to medicines for far more patients who need them.

Our growing global team of more than 11,000 colleagues spans six continents.

To learn more about BeOne, please visit www.beonemedicines.com and follow us on LinkedIn, X (formerly known as Twitter), Facebook and Instagram.

For more information, please visit the link to explore job opportunities in China Mainland.

China Mainland Job Posting At BeOne, how we work is just as important as the work we do. Below are our Values that determine the decisions we make and how we do things. Patients First Driving Excellence Bold Ingenuity Collaborative Spirit