Oncology Global Regulatory Submissions Lead

Merck; North Wales (Montgomery County); Ibrido; USD 129.000 - 203.000; Tempo pieno

Vantaggi offerti da questo lavoro

Medical, dental, vision

401(k) retirement plan

Paid holidays

Vacation

Sick days

Descrizione del lavoro

Merck is seeking an Associate Director, Regulatory Affairs in oncology to lead global regulatory strategies and submissions. You will collaborate with a global regulatory team to develop and implement registration plans, manage agency communications, and drive regulatory milestones across product life cycles.

The role emphasizes strong communication, analytical skills, and coordination with clinical safety, labeling, CMC, and regulatory operations to support therapy areas.

Competenze

• Experience in drug development.
• Prior regulatory experience interacting with a major regulatory agency.
• Excellent communication skills (oral and written).
• Strong organizational skills with ability to balance multiple projects.
• Flexibility and adaptability.

Mansioni

• Assist in regulatory agency communications and submissions, including marketing applications and INDs.
• Develop and implement global regulatory strategy and background packages for submissions.
• Communicate with regulatory agencies and attend meetings as needed.
• Collaborate with cross-functional teams to align regulatory strategy.
• Research guidelines and competitive intelligence to inform regulatory strategy.

Conoscenze

Cross-Functional Teamwork

Global Regulatory

Investigational New Drug

Label Development

Life Cycle Planning

Pharmaceutical Industry

Product Registrations

Regulatory Communications

Regulatory Documents

Regulatory Experience

Regulatory Filings

Regulatory Reporting

Regulatory Strategies

Regulatory Submissions

Stakeholder Engagement

Formazione

Bachelor’s Degree

Master’s Degree

M.D./Ph.D./Doctoral Degree

Descrizione del lavoro

Merck is seeking an Associate Director, Regulatory Affairs in oncology to lead global regulatory strategies and submissions. You will collaborate with a global regulatory team to develop and implement registration plans, manage agency communications, and drive regulatory milestones across product life cycles.

The role emphasizes strong communication, analytical skills, and coordination with clinical safety, labeling, CMC, and regulatory operations to support therapy areas.