CMC Project Manager

This is a fully remote position, open to applicants in Pennsylvania.

📋 Description

• Manage the delivery of regulatory affairs.

• Mentor your team and promote ongoing enhancements.

• Engage in providing regulatory expertise in the strategic development of drugs across various domains.

• Assist in the formulation of strategic development and submission plans.

• Participate in regulatory affairs initiatives throughout the ICON portfolio, serving as an expert and advisor to ICON clients.

• Represent the Regulatory Affairs Department in business development efforts and create new business prospects.

• Contribute to at least two of the following areas: interactions with regulatory bodies, early phase consulting, development planning, scientific/agency guidance, orphan drugs/pediatric development, and medical devices.

⛳️ Requirements

• A bachelor's degree in a relevant scientific discipline or a healthcare-related field.

• Extensive proven expertise in regulatory affairs (EU/APAC).

• A minimum of 7 years of experience, including supervisory roles, within the pharmaceutical/CRO industry (US/LATAM/CAN).

• Demonstrated experience in regulatory affairs, encompassing the development of regulatory strategies, document preparation, marketing authorization applications, clinical trials, post-licensing activities, and direct interactions with regulatory agencies.

• Strong organizational skills, capability to handle multiple tasks, and a keen attention to detail.

• Excellent written and verbal communication, management skills, proven presentation abilities, problem-solving capabilities, strong interpersonal skills, and effective planning/organization skills.

🏝️ Benefits

• Competitive base salary along with performance-related incentives.

• Health and wellness programs, including medical, dental, and vision coverage where applicable.

• Retirement and pension plans.

• Life insurance and disability coverage.

• Employee assistance programs and wellness resources.

• Learning and development opportunities through structured training and career pathways.