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  3. Associate Director, Global Regulatory Affairs - Ad / Promo

Associate Director, Global Regulatory Affairs - Ad / Promo

BioNTech
Posted 10 months ago, valid for 8 days
Location

Cambridge, MA 02139, US

Salary

$166,000 - $203,000 per year

Contract type

Full Time

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Sonic Summary

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  • The Associate Director, Regulatory Affairs (Advertising and Promotion) at BioNTech will oversee the review and approval of promotional materials and medical communications for assigned brands.
  • This role requires a minimum of 8 years of experience in the pharmaceutical industry, with at least 5 years in regulatory affairs, and a BS in a scientific discipline is required.
  • The expected salary range for this position is between $166,000 and $203,000 per year, along with benefits, an annual bonus, and equity based on performance.
  • Key responsibilities include serving as a subject matter expert on FDA advertising regulations, ensuring compliance, and managing interactions with the FDA's OPDP/APLB.
  • Candidates with experience in Oncology and strong knowledge of advertising promotion regulations will be preferred for this leadership position.

Cambridge, US; New Jersey, US   |   full time   |   Job ID: 9842 

 

 

About the role:


As an Associate Director in Regulatory Affairs, Advertising and Promotion at BioNTech, you will play a pivotal role in ensuring our promotional materials and medical communications comply with FDA regulations. Your expertise will directly contribute to advancing our mission of developing innovative therapies that improve global health.  You’ll lead interactions with the FDA Office of Prescription Drug Promotion (OPDP) and Advertising and Promotion Labeling Branch (APLB), ensuring alignment with regulatory requirements while supporting our commercial success. Collaborating closely with cross-functional teams, you’ll help shape advertising strategies that uphold BioNTech’s commitment to integrity and excellence.

 

Your contribution:

 

  • Act as the internal subject matter expert on FDA Advertising & Promotion matters, providing regulatory advice for assigned products.
  • Review and approve promotional materials using BioNTech’s content management systems to ensure compliance with FDA regulations.
  • Oversee timely and accurate FDA 2253 submissions for U.S. promotional materials.
  • Serve as the primary liaison with OPDP/APLB, managing high-quality submissions and responses to regulatory inquiries.
  • Develop streamlined processes for promotional material reviews while maintaining adherence to policy standards.
  • Provide training on FDA requirements, PhRMA DTC Guidelines, and company policies to enhance compliance across teams.

 

A good match:

 

  • A Bachelor’s degree in a scientific discipline (minimum requirement) with significant experience in the pharmaceutical industry, including 5+ years in regulatory affairs.
  • Deep knowledge of advertising promotion regulations and FDA guidance documents.
  • Proven expertise in managing OPDP submissions and interactions with FDA regarding advertising materials.
  • Strong collaborative skills to work effectively with Commercial, Medical Affairs, Legal, and other internal stakeholders.
  • Experience in oncology is a plus.

 

 

At BioNTech, we are committed to improving global health through innovative therapies. If you're ready to bring your expertise to a dynamic team dedicated to making an impact, we invite you to apply.

 

 

Your benefits and remuneration:

 

If the position is filled in the US, the Expected Pay Range is $146,300/year to $234,100/year + benefits, annual bonus & equity (bonus and equity is variable and dependent on company and individual performance). Compensation for the role will depend on several factors, including responsibilities of the job, education, experience, knowledge, skills, and abilities. 

Compensation at other locations may vary significantly. 

 

BioNTech is committed to the wellbeing of our team members and offers a variety of benefits in support of our diverse employee base. We offer competitive remuneration packages which is determined by the specific role, location of employment and also the selected candidate’s qualifications and experience.

 

Note: The availability, eligibility and design of the listed benefits may vary depending on the location. The final requirements for the individual use of our benefits are based on the company's internal policies and applicable law.

 

How to apply:

 

Apply now by sending us your application documents including Curriculum Vitae, copy of ID, copies of degree certificates and professional certificates, motivation letter as well as your contact details via our online form.

 

Please note:

Only applications sent via our online form shall be considered. By submitting your application, you acknowledge that a background check will be conducted as part of the recruitment process in accordance with applicable laws and regulations. If you are considered for the position, BioNTech will conduct the background check through our service provider ‘HireRight’. You will be informed accordingly by your BioNTech-Recruiter.

 

We are looking forward receiving your application.



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