Senior Manager Regulatory Advertising and Promotion

The Senior Manager Regulatory Advertising and Promotion N.A. will be responsible for ensuring that product and disease communications comply with applicable laws regulations Sobi policies and regulatory requirements for both promotional and non-promotional materials related to assigned product(s). Reporting to the Global Head of Regulatory Advertising and Promotion this role will serve as the primary regulatory reviewer on the Sobi Review Committee(s) for promotional and non-promotional materials. The incumbent will provide strategic regulatory guidance based on a strong understanding and sound interpretation of FDA regulations guidance documents OPDP/APLB precedents and industry best practices.

This position requires frequent interaction and strong collaboration with cross-functional partners including Legal Medical Compliance Marketing Labeling and other teams to develop strategies and implement tactics for compliant communications that align with Sobis corporate and brand objectives.

This is a remote role with occasional travel to Sobi sites for business-critical meetings and events.

Key Responsibilities

• Serve as the primary regulatory reviewer for assigned product(s) on the Sobi Review Committee (SRC).

• Review materials provide real-time regulatory risk assessments and recommend mitigation strategies.

• Collaborate with cross-functional teamsincluding Medical Legal and Commercialto ensure that product and disease-state communications meet regulatory requirements.

• Monitor the external environment to keep product teams informed of evolving regulatory requirements related to advertising and promotion and assess potential impacts on marketing activities.

• Plan and deliver training to internal stakeholders on U.S. laws codes and regulations related to drug advertising and promotion.

• Provide input into label development with consideration of promotional implications including the evaluation of potential labeling claims.

• Ensure changes in product labeling are implemented into promotional materials in accordance with company procedures and regulatory requirements.

• Represent Regulatory Advertising and Promotion on cross-functional project teams and other relevant programs as needed.

• Collaborate with cross-functional teams to optimize the material review process.

Qualifications :

• Minimum of a Bachelors degree in a scientific discipline required

• Advanced scientific degree (e.g. MS PharmD PhD MD) preferred

• Minimum of 35 years of experience in the pharmaceutical industry including at least 2 years in Regulatory Advertising and Promotion

• Expert knowledge of U.S. advertising and promotion regulations and FDA guidance documents

• Direct experience supporting promotional review of product communications and engaging with FDA (OPDP or APLB) on advertising and promotion matters

• Experience in rare diseases hematology and/or immunology is a plus

• Proficiency with Veeva Vault PromoMats

• General understanding of clinical study design and statistical analysis as it relates to promotional claims

• Familiarity with the drug development process and drug labeling

• Strong interpersonal and communication skills with the ability to lead and influence without direct authority

• Ability to creatively analyze complex issues and develop practical compliant solutions

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 $133000-$180000. 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 Sobis 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 1700 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 were ready to take on the worlds diseases ailments and adversity. Our people believe they have the power to make a positive impact in others lives because thats exactly what we do here. If youre 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 cant 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.

Sobi is an affirmative action and equal opportunity employer. Disabled/Veterans. 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

COVID-19 Policy

For the safety of our employees and all individuals with whom we interact professionally Sobi North America requires all new hires in the U.S. to be fully vaccinated for COVID-19 with proof of vaccination status. We will consider requests for reasonable medical or religious accommodations as well as any state-specific exemptions as required by applicable law.