Regulatory Affairs Consultant Job

REGULATORY AFFAIRS CONSULTANT needed for a contract opportunity with Yoh's client located in San Francisco, CA.

The Big Picture - Top Skills You Should Possess:
- Regulatory affairs with Drugs
- cGXP Regulations
- Managing regulatory activities

What You'll Be Doing:
- Responsible for managing regulatory activities that support department and company projects and programs.
- Manages external resources to ensure quality and timeliness of submissions.
- Coordinates, prepares, edits and submits responses to regulatory authorities.
- Establishes and assures adherence to schedules, work plans and performance requirements.
- Has primary responsibility for coordinating the preparation of drafts, edits, review and submission of regulatory dossiers in support of investigational and/or new drug applications.
- Works with project teams and department management to develop regulatory strategies, identify regulatory risks, and enable earliest possible approval.
- Ensures that submissions meet format and content requirements applicable to specific health authority regulatory requirements (ie, US, ICH, and EU).
- Provides input on, and reviews protocols, reports, labeling, and etc. for regulatory compliance.
- Ensures that documentation for all projects is maintained and kept current.
- Participates in, and provides regulatory guidance to working teams and Project Teams.
- Manages timelines for regulatory submissions.
- Solves problems of significant levels of complexity following established company policies and procedures; informs management of impacts.
- Works independently to complete assigned projects; keeps management informed on progress.
- Interacts and supervises the activities of contract organizations and consultants in the preparation of regulatory submissions as necessary.

What You Need to Bring to the Table:
- A minimum of a Bachelor's degree in a scientific discipline is required, equivalent experience may be accepted.
- A minimum of ten (10) years pharmaceutical or other related industry is required.
- Minimum of eight (8) years of hands-on Regulatory Affairs experience in drugs is required.
- Strong verbal and written communication skills are required, as well as presentation skills; must be able to present departmental policies and practices.
- Must be detail- and goal-oriented, quality conscientious, and customer-focused.
- Must be able to adhere to strict project timelines, and to advise teams and management of impacts and changes in project timelines.
- Experience working in a multi-disciplinary team environment is required.
- Ability to manage changing priorities, multiple tasks, and to communicate impact to project teams is required.
- Strong computer skills in Word, Excel, PowerPoint and Adobe Acrobat, and working knowledge of electronic publishing/file management systems are an asset; can use Internet for research applications.
- Must possess an understanding of cGXP regulations and provide guidance to project teams on regulatory compliance issues.

WHAT ARE YOU WAITING FOR? APPLY NOW!

RECRUITER: Will Thompson

Yoh, a DayJ2W: SCIENTIFIC

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