Associate Director, Regulatory Affairs, International

The Role:

The Associate Director of Regulatory Affairs-International will play a key role in shaping the strategic direction of regulatory affairs in the LATAM region. With a focus on messenger RNA therapeutics, this individual will work with multiple teams ensuring the integration of the regulatory strategy with the company's long-term goals.  This is a role intended for a forward looking, creative and agile regulatory professional able to anticipate and address the challenges involved in developing the regulatory strategy in LATAM.

Here's What You’ll Do:

• Contribute to the strategic direction of regulatory affairs in LATAM, including policy shaping and long-term goal setting.

• Exercise decision-making authority to guide regulatory strategy and operations in the LATAM region, ensuring alignment with company objectives.

• Leading through regulatory professionals supporting the LATAM region.

• Identify and solve complex problems across functions, leveraging sophisticated analytical skills to influence business outcomes.

• Spearhead cross-functional initiatives, promoting collaboration across various departments to achieve regulatory milestones.

• Oversee the regulatory impact on sub-functions or multiple areas within the organization, extending beyond direct project involvement.

• Engage with LATAM agencies and local partners influencing key business decisions and regulatory policies.

• Responsible for oversighting regulatory submissions in the LATAM region

Here’s What You’ll Bring to the Table:

• Degree in Life Science or related discipline (e.g. Pharmacy, Biology, Biochemical, Bioengineering), advanced degree preferred (PharmD, MSc, PhD)

• 10+ years of experience in Regulatory Affairs or related field

• Expertise in biologics, vaccines, Rare or Autoimmune Diseases, and Oncology, with a strong command of current LATAM regulations.

• Proven ability to navigate the regulatory landscape, including comprehensive knowledge of LATAM, US, and EU regulations for biologic products.

• Exceptional communication skills, with fluency in Spanish and English, capable of effectively conveying complex regulatory strategies to diverse audiences.

• A dynamic, collaborative approach to working in a cross-functional matrix environment, with a bold, relentless, curious, and collaborative mindset.

• Experience and knowledge in the preparation of major regulatory submissions and supportive amendments or supplements

• Ability to effectively collaborate in a dynamic, cross-functional matrix environment to meeting each program’s critical regulatory milestones.

Moderna is pleased to provide you and your family with a comprehensive and innovative suite of benefits, including:

• Highly competitive and inclusive medical, dental and vision coverage options
• Flexible Spending Accounts for medical expenses and dependent care expenses
• Lifestyle Spending Account funds to help you engage in personal enrichment and self-care activities
• Family care benefits, including subsidized back-up care options and on-demand tutoring
• Free premium access to fitness, nutrition, and mindfulness classes 
• Exclusive preferred pricing on Peloton fitness equipment
• Adoption and family-planning benefits
• Dedicated care coordination support for our LGBTQ+ community
• Generous paid time off, including:
  •    Vacation, sick time and holidays
  •    Volunteer time to participate within your community
  •    Discretionary year-end shutdown
  •    Paid sabbatical after 5 years; every 3 years thereafter
• Generous Paid Leave offerings, including 18 weeks of 100% paid parental leave for all new parents
• 401k match and Financial Planning tools
• Moderna-paid Life, LTD and STD insurance coverages, as well as voluntary benefit options
• Complimentary concierge service including home services research, travel booking, and entertainment requests
• Free parking or subsidized commuter passes
• Location-specific perks and extras!

About Moderna

Since our founding in 2010, we have aspired to build the leading mRNA technology platform, the infrastructure to reimagine how medicines are created and delivered, and a world-class team. We believe in giving our people a platform to change medicine and an opportunity to change the world. 

By living our mission, values, and mindsets every day, our people are the driving force behind our scientific progress and our culture. Together, we are creating a culture of belonging and building an organization that cares deeply for our patients, our employees, the environment, and our communities.

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