Regulatory Affairs Manager

US Tech Solutions; Lake Forest (IL); On-site; USD 100,000 - 130,000; Full time

Job summary

A global staff augmentation firm is seeking a Senior Regulatory Affairs professional to oversee drug product development and compliance. This role requires a minimum of 5 years of experience in drug development, including direct management of new drug approvals. Responsibilities include regulatory guidance, communication with health authorities, and strategic planning for submissions. Join a dynamic team aiming for mutual growth and innovation in pharmaceutical projects.

Qualifications

• Minimum of 5 years of experience in drug development and registration activities.
• Experience managing an approved new drug from inception to market.
• Capability to lead and motivate staff.

Responsibilities

• Serve as senior regulatory affairs member of project teams focused on drug products.
• Provide regulatory guidance on compliance and FDA requirements.
• Develop regulatory submission strategies aligned with product development.
• Liaise with FDA and health authorities for IND and NDA projects.

Skills

Regulatory oversight

Drug development

Compliance knowledge

Leadership

Strategic development

Job description

US Tech Solutions is a global staff augmentation firm providing a wide-range of talent on-demand and total workforce solutions. To know more about US Tech Solutions, please visit our website www.ustechsolutions.com.

We are constantly on the lookout for professionals to fulfill the staffing needs of our clients, sets the correct expectation and thus becomes an accelerator in the mutual growth of the individual and the organization as well.

Keeping the same intent in mind, we would like you to consider the job opening with US Tech Solutions that fits your expertise and skillset.

Job Description

• Serve as the senior and principal regulatory affairs member of project development teams, primarily focused on (but not limited to) drug products.
• Provide regulatory oversight and guidance to project teams on compliance matters, FDA requirements, clinical study design issues and on timing, logistics and operational recommendations for product development.
• Develop regulatory submission strategies in agreement with defined product development objectives.
• Serve as the principal regulatory affairs liaison to FDA and other health authorities for assigned Investigational New Drug (IND) and New Drug Applications (NDA) projects. Prepare and submit IND and NDA applications, as well as various amendments and supplements.
• Minimum of 5 years + experience in drug development and registration activities, including personal management of an approved new drug from initial development through to approval and market launch.
• Prior management experience, with a demonstrated capability to lead and motivate staff is essential.
• Demonstrated strategic development capabilities related to new drug development and commercial support activities are critical.

Qualifications

• Minimum of 5 years + experience in drug development and registration activities, including personal management of an approved new drug from initial development through to approval and market launch.
• Prepare and submit IND and NDA applications, as well as various amendments and supplements.