Global Regulatory Strategy Leader, Oncology

Regulatory Jobs; Cambridge (MA); In loco; USD 197.000 - 353.000; Tempo pieno

Vantaggi offerti da questo lavoro

Healthcare benefits

Well-being programs

Family planning support

Generous paid time off

Savings and investments

Location-specific perks

Descrizione del lavoro

Moderna Therapeutics is seeking a Senior Director of Regulatory Strategy to lead regulatory plans for oncology programs from its Cambridge, MA headquarters. The role requires strategic leadership in regulatory affairs, expert guidance on global strategies, and collaboration across teams to navigate US/EU regulatory landscapes for mRNA therapeutics.

You will oversee submissions, maintain relationships with health authorities, and ensure alignment with business objectives while managing resources

Competenze

• BA/BS degree in a scientific/engineering discipline.
• 12+ years of experience in the Pharmaceutical industry.
• 8+ years of experience in Regulatory strategy, including oncology.
• Strong knowledge of current US and EU regulations, including novel regulatory pathways.
• Strong experience with CTD format and content regulatory filings.
• Exceptional written and oral communication; stakeholder management.
• Demonstrated leadership and ability to develop direct reports.

Mansioni

• Sets strategic direction and leads regulatory submissions and amendments.
• Advises project teams on regulatory strategy through development processes.
• Establishes and maintains relationships with global health agencies.
• Negotiates with health agencies and responds to data requests.
• Reviews data and ensures accuracy for regulatory filings.
• Develops and reviews regulatory policies in compliance with agencies.

Conoscenze

Regulatory strategy leadership

CTD submissions

Regulatory affairs

Stakeholder management

Regulatory filings

Global health agencies

Communication skills

Team leadership

Formazione

BA/BS in science/engineering

Strumenti

CTD format experience

Regulatory submission tools

Descrizione del lavoro

Moderna Therapeutics is seeking a Senior Director of Regulatory Strategy to lead regulatory plans for oncology programs from its Cambridge, MA headquarters. The role requires strategic leadership in regulatory affairs, expert guidance on global strategies, and collaboration across teams to navigate US/EU regulatory landscapes for mRNA therapeutics.

You will oversee submissions, maintain relationships with health authorities, and ensure alignment with business objectives while managing resources