Regulatory Affairs Manager jobs in Indiana

Initial 9 month onsite contract with possible extension and/or conversion to permanent employment.

The main focus of this position will be on new submissions associated with new chemical entity (NCE) as well as products already in non-clinical and/or clinical studies.

Qualifications:

• Bachelor of Science in Chemistry, pharmacy, biology or other life science, plus direct experience managing regulatory activities
• 12 years of relevant Regulatory Affairs pharmaceutical industry experience.
• 2 of supervisory experience of direct reports required, matrix management experience preferred.
• Experience in leading new project submission efforts including strategy, compilation, submission, and approval by a health authority.
• Experience writing Target Product Profiles, non-clinical studies, reviewing Clinical protocols and summary reports.

Job Description:

• Manage submissions and projects as assigned by Regulatory leadership assuring compliance, planning, and execution
• Critically review documentation for regulatory submissions and provide input for necessary revisions
• Contribute to defining Target Product Profile and build compliant drug “approvable” dossiers and registration
• Maintain associated database for tracking individual and department project deliverables for regulatory submissions

Job Disclaimer:

Equal Opportunity Employer/Veterans/Disabled

Benefit offerings include medical, dental, vision, term life insurance, short-term disability insurance, additional voluntary benefits, commuter benefits and 401K plan. Our program provides employees the flexibility to choose the type of coverage that meets their individual needs. Available paid leave may include Paid Sick Leave, where required by law; any other paid leave required by Federal, State or local law; and Holiday pay upon meeting eligibility criteria. Disclaimer: These benefit offerings do not apply to client-recruited jobs and jobs which are direct hire to a client

To read our Candidate Privacy Information Statement, which explains how we will use your information, please visit https://www.entegee.com/candidate-privacy-information-statement/

The Company will consider qualified applicants with arrest and conviction records.

Job Type: Contract

Pay: $54.00 - $64.00 per hour

Expected hours: 40 per week

Benefits:

• 401(k)
• Dental insurance
• Health insurance
• Life insurance
• Vision insurance

Experience level:

• 10 years

Schedule:

• 8 hour shift
• Day shift
• Monday to Friday

Education:

• Bachelor's (Required)

Experience:

• Regulatory Affairs: 10 years (Required)
• Pharmaceutical industry: 10 years (Required)
• Supervisory: 2 years (Required)

Ability to Relocate:

• Noblesville, IN 46060: Relocate before starting work (Required)

Work Location: In person