Global Regulatory Affairs Lead, Associate Director

Kailera Therapeutics; Waltham (MA); Presencial; USD 155 000 - 190 000; Tempo integral

Vantagens oferecidas por esta oferta de emprego

Health coverage

Paid holidays

Wellness stipend

401(k) match

Tuition reimbursement

Commuter benefits

Equity grants

Annual bonus opportunities

Disability and life insurance

Resumo da oferta

Kailera Therapeutics is seeking an Associate Director, Global Regulatory Affairs to lead day-to-day regulatory activities for early and late-stage investigational products, guiding IND/CTA submissions and future marketing applications. You will partner with Regulatory CMC and Operations to align data with agency expectations.

Required location: Waltham, MA, hub-based onsite 3-4 days/week. A Bachelor’s with 10+ years or an Advanced degree with 5+ years in drug development is required.

Qualificações

• Experience in design and conduct of clinical trials and preparation of regulatory submissions.
• Knowledge of US and international regulatory guidelines and regulations.
• Deep knowledge of the integrated drug development process.
• Ability to assess and manage risk in a highly regulated environment.
• Willingness to travel 10-15%.

Responsabilidades

• Serve as regulatory representative on core teams and coordinate regulatory submissions.
• Oversee compilation, review, and submission of regulatory applications to agencies.
• Monitor regulatory environment and communicate developments to stakeholders.
• Stay updated on global regulatory guidance and ensure compliance with reporting requirements.
• Respond to regulatory questions with cross-functional collaboration.
• Provide strategic regulatory guidance for global development and registrations.
• Assess regulatory requirements to ensure development activities follow regulations.
• Contribute to internal processes and SOPs.

Conhecimentos

Regulatory strategy

Regulatory submissions

Cross-functional collaboration

Regulatory intelligence

Communication

Travel readiness

Formação académica

Bachelor's degree with 10+ years of relevant drug development experience

Advanced degree (PhD, PharmD, MS, MBA) with 5+ years of relevant drug development experience

Descrição da oferta de emprego

Kailera Therapeutics is seeking an Associate Director, Global Regulatory Affairs to lead day-to-day regulatory activities for early and late-stage investigational products, guiding IND/CTA submissions and future marketing applications. You will partner with Regulatory CMC and Operations to align data with agency expectations.

Required location: Waltham, MA, hub-based onsite 3-4 days/week. A Bachelor’s with 10+ years or an Advanced degree with 5+ years in drug development is required.