Associate Specialist, Portfolio & Program Management - Hybrid

Job Description

Description

The Associate Specialist of Regulatory Planning & Publishing works closely with various stakeholders of regulatory and safety submissions to assist in activities related to planning, execution, and management of delivery of high quality and timely regulatory submissions.

The responsibilities of the incumbent may include the following:

• Maintain accountability for use of established planning and tracking practices and systems

• Participate in pilots for new tools and processes

• Collaborate with colleagues inside and outside of the department, as appropriate

• Participate in training courses to increase job role skills and regulatory knowledge

Program:

• Support in the creation of FDA cover letters and forms, creation of submission plans, assist in tracking deliverable timelines of components, and archiving in systems

Shared Services: (Regulatory Submission Specialist)

• Provide regulatory submission/systems support

• Manage regulatory documents, assisting in tracking timelines/deliverables and/or components and promptly responding to updates

Qualifications, Skills & Experience

• High School Diploma or equivalent (no relative experience)

• Ability to communicate effectively, both verbally and written with others across cultures and organizational levels

• Demonstrates the ability to independently solve problems that arise within job responsibilities and expectations of this role

• Familiar with computer systems (MS Office necessary; Advanced Excel and Word skills preferred)

• Highly organized individual with keen attention to detail Desired Experience, Education & Skills: v Demonstrated leadership, initiative, and ownership of deliverables

MSJR

Required Skills:

Adverse Event Report, Audits Compliance, Communication, Compliance Remediation, Customer Satisfaction, Data Quality Assurance, Document Control Systems, Electronic Common Technical Document (eCTD), Employee Training Programs, Leadership, Management Process, Manufacturing Quality Control, Organizational Performance Management, Quality Management, Regulatory Affairs Compliance, Regulatory Change Management, Regulatory Communications, Regulatory Documents, Regulatory Management, Regulatory Project Management, Regulatory Strategies, Regulatory Strategy Development, Regulatory Submissions, Samarind RMS, Technical Documentation Management

Preferred Skills:

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