Director, Regulatory Advertising and Promotion N.A.

The Director Regulatory Advertising and Promotion N.A is responsible for providing strategic and tactical regulatory ad promo support and guidance related to product and disease state communications for assigned product(s) or therapeutic area across the product life cycle.  As the internal subject matter expert on FDA regulations of prescription drug advertising and promotion this role collaborates extensively with cross-functional teams to ensure that promotional communications are compliant and meet business objectives.   The incumbent will serve as the primary liaison with the FDAs office of prescription Drug Promotion (OPDP) and

This role will report to the Global Head of Regulatory Advertising and Promotion and will have accountability for the review and approval of US promotional and non-promotional communications of assigned product(s). This experienced regulatory professional will contribute to the ongoing development of a best-in-class Regulatory Advertising and Promotion team.

This role is remote based on US Eastern time with limited travel to for business-critical meetings / events.

Key Responsibilities

• Serve as lead regulatory reviewer for assigned product(s) on Sobi Review Committee (SRC) and as Regulatory Adpromo representative on relevant programs and other cross-functional teams.
• Review draft materials and collaborate with cross-functions including Medical Legal and Marketing etc to ensure that product and disease-state communications are compliant and impactful
• Provide strategic direction and clearly articulate any potential risks in draft materials along with sound rationales and anticipated likely outcomes.
• Partner with the business by providing alternatives to achieve business objectives
• Build and maintain strategic relationships with regulatory authorities- FDA OPDP ABLB to support Sobi business objectives.
• Proactively monitor and interpret monitor FDA enforcement actions and regulatory trends; assesses impact to support successful and compliant marketing of Sobi products.
• Assess the impact of proposed label wording or label changes on promotional strategy and provide input for label optimization as a member of the Label Working Group.
• Provide direction and work collaboratively to ensure that changes in product labeling are implemented in promotional materials in accordance with company procedures and regulatory requirements.
• Contribute to departmental and cross-functional efforts to develop and update applicable policies procedures guidelines and training.
• Responsible for a variety of tasks requiring sound judgment and independent initiative.
• Develop and conducts stakeholder training on matters pertaining to prescription drug promotion

Qualifications : Qualifications

Education

Required : Minimum Bachelors Degree in a scientific or healthcare-related field with minimum 10 years of related biopharma experience

Preferred : Advanced scientific degree (MD PharmD PhD) or Juris Doctor with a minimum of 8 years related biopharma experience

Experience and skills :

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 :

The base salary range for this role is . 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.

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

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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.

Remote Work : Yes

Employment Type : Full-time

Key Skills

Sales Experience,Digital Marketing,Marketing,Google AdWords,Google Ads,Account Management,Adobe Audience Manager,Agency Management,Social Media Advertising,DoubleClick,DoubleClick for Publishers,Lead Generation

Experience : years

Vacancy : 1