The posting
Company Description
Statistics show that women and underrepresented groups tend to apply to jobs only if they meet 100% of the qualifications. Sobi encourages you to change that statistic and apply. Rarely do candidates meet 100% of the qualifications. We look forward to your application!
At Sobi, each person brings their unique talents to work as a team and make a difference. We are dedicated to developing and delivering innovative therapies to improve the lives of people who live with a rare disease. Our edge comes from our team of people and our commitment to patients.
Our mission and culture at Sobi get us excited to come to work every day, but here are a few more reasons to join our team:
- Competitive compensation for your work
- Generous time off policy
- Summer Fridays
- Opportunity to broaden your horizons by attending popular conferences
- Emphasis on work/life balance
- Collaborative and team-oriented environment
- Making a positive impact to help ultra-rare disease patients who are in need of life saving treatments
Job Description
The Head of Global Regulatory Advertising & Promotion will report to the Head of the Global Regulatory Policy, Intelligence and Advertising & Promotion, be a core member of the GRA Extended Leadership Team (ELT), and have accountability for 6 or more direct reports. This role is responsible for leading and directing post-marketing regulatory activities pertaining to marketing of Sobi products, including regulatory review and approval of U.S. promotional, corporate, and medical communications of assigned brand(s), submission to FDA OPDP/APLB, and be the owner of the Sobi Global Material review process.
The role is responsible for leading interactions with the FDA Office of Product Prescription and Drug Promotion be responsible to function as a leader during review and escalation meetings to assure compliance with and evolution of the applicable Review process enabling business needs to be met in a compelling, compliant, and timely way.
This position requires frequent interaction and strong collaboration with cross-functional partners for the purpose of providing regulatory advice and guidance throughout the product life cycle assuring conformity with applicable laws, regulations and Sobi policies.
- Provides vision, strategy and leads the adpromo team reporting into them
- Develops and leads departmental strategic initiatives
- Serve as strategic partner to internal leadership on regulatory risk assessment and mitigation
- Oversees and directs the adpromo team in assessing regulatory context and provides regulatory interpretations of applicable guidance and/or regulations or regulatory precedents
- Demonstrate leadership as the Regulatory Advertising and Promotion Leader
- Business owner of the Global Review Process
- Provides regulatory advice and guidance on Advertising and Promotion for Global promotional and non-promotional materials
- Serves as an internal subject matter expert on FDA Advertising & Promotion issues providing regulatory advice and offering solutions to regulatory concerns on draft promotional materials to ensure compliance with FDA regulations
- Lead interactions with OPDP/APLB, including proactive engagement with OPDP/APLB in support of business needs, and as needed, response to regulatory inquiries.
- Foster a healthy business partnership environment with cross-functional stakeholders to ensure company meets strategic business objectives
- Provides regulatory training as needed on applicable laws, regulations and Sobi policies
- Demonstrate leadership as the regulatory reviewer on Review Committees (RCs)
- Lead development of SOPs and Work Instructions to drive compliance through streamlined workflows and efficient execution of relevant processes
Qualifications
Education/Learning Experience/Work Experience
Required: Minimum BS in Scientific discipline
Desired: Advanced scientific degree (PhD, MD, PharmD, etc) or Juris Doctor preferred
- Minimum of 15 years of experience in pharmaceutical industry and a minimum of 5 years as a regulatory Ad & Promo professional
- Experience in Rare Diseases, Hematology and/or Oncology a plus
- Expert knowledge of advertising promotion regulations and FDA Guidance documents issued with some technical experience in aspects of drug development and labeling
- Advanced experience with promotional and medical review supporting product communications and working with FDA (OPDP, APLB) on advertising and promotion matters
Skills/Knowledge/Languages
Required:
- Advanced understanding of FDA promotional regulations, industry trends, regulatory landscape, product and therapeutic knowledge as well as evidentiary standards required to support product claims
- Apply advanced regulatory experience and business knowledge in the development of new ideas and best practices that support Sobi
- Advanced ability to spot issues and convey facts and risk mitigation strategies and guidance, including impact to Sobi without sufficient risk mitigation
- Demonstrate understanding of company objectives while executing regulatory strategies that deliver efficacious and FDA-compliant outcomes
- Must reasonably foresee situations that are likely to be vague or challenging, and strategize to prevent or mitigate negative impact
- Demonstrates the ability to build agreement and acceptance through the ability to present a compelling case for ideas, negotiate persuasively, and address disagreements constructively
- Efficiently and systematically plan, prioritize, and execute individual work, team work, and projects while balancing quality, cost, risk, and benefits
- Proficient in the use of AI digital tools.
- Occasional travel for Sobi business-critical meetings/events.
Additional Information
Compensation and Total Rewards at Sobi
At Sobi, we are dedicated to providing our employees with a comprehensive and industry-competitive total rewards package. Our compensation philosophy is designed to recognize and reward talent, ensuring that your contributions are valued and reflected in your overall rewards.
Your total compensation at Sobi goes beyond just your base salary and annual bonus. It also includes a robust suite of benefits, such as:
- A competitive 401(k) match to support your financial future.
- Tuition and wellness reimbursements to invest in your personal and professional growth.
- A comprehensive medical, dental, and vision package to prioritize your health and well-being.
- Additional recognition awards to celebrate your achievements.
The base salary range for this role is $260,000-290,000. Each individual offer will be determined based on several factors, including your experience, qualifications, and location. Additionally, this role is eligible for both short-term and long-term bonuses, as outlined in the plan details.
All Sobi employees need to demonstrate behaviors in line with Sobi's core values: Care, Ambition, Urgency, Ownership and Partnership. Are you ready to be on the Sobi team? Come join a culture that empowers every person to be the person that makes a difference for rare disease.
Why Join Us?
We are a global company with over 1,900 employees in more than 30 countries and are committed to the societies where we operate. With a deeply skilled management team directing our day-to-day wins, and a Board with a stellar track record, we’re ready to take on the world’s diseases, ailments and adversity. Our people believe they have the power to make a positive impact in others’ lives because that’s exactly what we do here. If you’re seeking a career that taps into your talents in a way that makes the world a better, healthier place, we just may have a job for you.
We know our employees are our most valuable asset, and our culture conveys that. We offer a competitive benefits package, to support the health and happiness of our staff.
Sobi Culture
At Sobi, we refuse to accept the status quo. This is because we have witnessed first-hand the challenges facing those affected by rare diseases, and have used this knowledge to shape our business to find new ways of helping them.
As a specialized biopharmaceutical company, we are dedicated to rare diseases. And we see this focus as a strength. By effectively turning our research into ground-breaking treatments, we help make medicine more accessible and open up more possibilities for patients and more opportunities for those caring for them. This has been our approach since day one, but we know we can’t change the world of rare diseases on our own. Accomplishing this requires strong partnerships with patients, partners and stakeholders across the entire value chain. Together, we define how our business can create solutions that serve the needs of those affected by rare diseases while facilitating sustainable growth.
An Equal Opportunity Employer
Sobi is an Equal Opportunity Employer and prohibits discrimination and harassment of any kind. All employment decisions at Sobi are based on business needs, job requirements and individual qualifications, without regard to race, color, religion or belief, national, social or ethnic origin, sex (including pregnancy), age, physical, mental or sensory disability, HIV Status, sexual orientation, gender identity, protected veterans and/or expression, marital, civil union or domestic partnership status, past or present military service, family medical history or genetic information, family or parental status, or any other status or protected groups by the laws or regulations in the locations where we operate.
If you are a qualified individual with a disability or a disabled veteran, you may request a reasonable accommodation if you are unable or limited in your ability to use or access this website to apply for a vacancy as a result of your disability. You can request reasonable accommodations by sending an email to [email protected]
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