Job description

Regulatory Submission Publisher/Regulatory Operations Manager (ROM)/Associate Principal Specialist (Regulatory Drug Project Delivery).

Location: REMOTE - *West Coast Time Zone Preferred*

Contract: 12 months (_Possible Chance for Extension after initial 12 months.)_

Primary Responsibilities:

Prepares/agrees/executes global/regulatory tactical submission plans for allocated project/prod that implement the agreed regulatory strategy to develop and maintain products. Provides independent tactical/scientifically related guidance cross functional on aspects of regulatory affairs. Uses knowledge and experience in the regulatory field to influence functional objectives.

The ROM is an expert in end-to-end document and submission publishing. The ROM is also experienced in understanding requirements regarding the technical aspects of global regulatory submission publishing and dispatch to global Health Authorities.

Essential Requirements

• Super accelerated Submissions
• Experience as a document and submission publisher including knowledge of regulatory publishing tools, planning, preparation, and delivery of regulatory submissions throughout the product's life cycle across multiple markets
• Ability to provide global expertise on requirements for electronic document management and document (report level) publishing.
• Demonstrated ability to work collaboratively in a global team environment and to have good project management and time management skills
• A broad working knowledge of process improvement methodologies, tools, techniques and their application.
• A practical understanding and application of building/maintaining relationships with drug project team members
• Successful application of customer service level agreements
• The ability to manage routine quality, resource and performance issues to resolution.
• To work independently and to set and manage priorities, resources, performance targets and project objectives in a global environment.
• Ability to assess data, documentation, and processes for regulatory impact/compliance with relevant regulations and guidance, and clearly communicate requirements to immediate stakeholders.
• Ability to apply project management principles and techniques.
• Excellent English (written and verbal) communication skills.

Desirable Requirements

• Providing support to users with questions related to end-to-end document (report level) and submission publishing.
• Experience in the pharmaceutical industry and knowledge of the drug development process and product life-cycle
• Experience performing system administration for validated applications within a regulated environment.
• Good problem and conflict resolution skills.

Job Types: Full-time, Contract

Salary: $45.00 - $55.00 per hour

Benefits:

• Dental insurance
• Health insurance
• Vision insurance

Schedule:

• 8 hour shift
• Day shift
• Monday to Friday

Experience:

• Regulatory submissions: 3 years (Required)
• end-to-end document and submission publishing: 3 years (Required)
• electronic document management: 3 years (Required)
• document (report level) publishing: 3 years (Required)
• process improvement methodologies: 2 years (Required)
• project management principles and techniques: 2 years (Required)
• pharmaceutical industry: 2 years (Preferred)
• drug development process and product life-cycle: 2 years (Preferred)
• regulatory publishing tools: 2 years (Preferred)

Work Location: Remote

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