Regulatory Program Manager

Integrated Resources Inc.; Lower Gwynedd Township (Montgomery County); Vor Ort; USD 90.000 - 130.000; Vollzeit

Zusammenfassung

A leading staffing firm is seeking a Regulatory Program Manager for a project based in Spring House, PA. The successful candidate will manage regulatory processes, support decision-making, and collaborate across teams to maintain project timelines. Applicants should have a B.S. in a related field and extensive experience in regulatory affairs.

Qualifikationen

• 5+ years of relevant experience, including in pharmaceutical R&D and regulatory processes.
• Project management certification is a plus.

Aufgaben

• Provide business support to GRA, assist GRTs in resource planning.
• Manage regulatory processes from late development to launch.
• Coordinate health authority interactions and submissions.

Kenntnisse

Results-driven mindset

Ausbildung

B.S. or higher in a pharmaceutical-related field

Jobbeschreibung

Integrated Resources, Inc is a premier staffing firm recognized as one of the tri-states most well-respected professional specialty firms. IRI has built its reputation on excellent service and integrity since its inception in 1996. Our mission centers on delivering only the best quality talent, the first time and every time. We provide quality resources in four specialty areas: Information Technology (IT), Clinical Research, Rehabilitation Therapy, and Nursing.

Job Description

Job Title: Regulatory Program Manager

Location: Spring House PA
Duration: 07+ Months (Possibility of extension)

Responsibilities:

1. Consultancy Support: Provide business support to GRA, assist GRTs in resource planning, and create project and portfolio reports.
2. Program Management Support: Manage regulatory processes from late development to launch, represent Regulatory Program Management at GRT, translate regulatory strategies into deliverables, and support decision-making with scenario planning.
3. Collaborate closely with Regulatory Leaders, Liaisons, Professionals, and Submission Operations to coordinate health authority interactions and submissions.
4. Act as the single point of contact for Regulatory Program Management activities and lead cross-functional teams in executing regulatory strategies and submissions.
5. Monitor and report on regulatory milestones, decision points, and project timelines, including budget management.
6. Schedule Management: Own and maintain the Global Regulatory Affairs schedule in P5.
7. Project Management Team Support: Represent Regulatory Program Management at the PMT, ensure alignment with strategic goals, and manage regulatory development plans.
8. Qualifications: B.S. or higher in a pharmaceutical-related field, with 5+ years of relevant experience, including in pharmaceutical R&D and regulatory processes. Project management certification is a plus.
9. Critical Competencies: Results-driven mindset.

Additional Information

Thanks & Regards,

Seema Chawhan, Clinical Recruiter, Integrated Resources, Inc.

Contact: 732-844-8724 | LinkedIn Profile

Certified MBE, GSA Schedule 66 & 621I, JCAHO Certified for Healthcare Staffing