20 days old

REMOTE Regulatory Drug Operations Manager

Kelly Services
San Francisco, CA 94103
Kelly is hiring for a **REMOTE Regulatory Drug Operations Manager** position with one of our clients.

+ Full time - REMOTE *West Coast Time Zone Preferred*

+ 12 months contract (May be extended or converted)

+ $70/hr

Job Description:

+ 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.

+ Ability to manage routine quality, resource and performance issues to resolution.

+ 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.

+ Provides support to users with questions related to end-to-end document (report level) and submission publishing.

Qualifications and Education Requirements:

+ 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.

+ 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.

Preferred Skills:

+ Excellent English (written and verbal) communication skills.

+ Good problem and conflict resolution skills

+ 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


**You should know:** Your safety matters! Vaccination against COVID-19 may be a requirement for this job in compliance with current client and governmental policies. A Kelly recruiter will confirm and share more details with you during the interview process.

**Why Kelly** **** **Science & Clinical?**

Kelly Science & Clinical is your connection to premier scientific and clinical companies looking to hire industry experts just like you. Our team creates expert talent solutions to solve the worlds most critical challenges. Every day, we match science professionals with dream jobs that fit their skills, interests, and career goalsits the way we think job searching should be. Nearly 100 percent of our science recruiters have a professional background and education in science, so we know a thing or two about the science market and how to get your expertise noticed.

**About Kelly** ****

At Kelly, were always thinking about whats next and advising job seekers on new ways of working to reach their full potential. In fact, were a leading advocate for temporary/nontraditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live (plus, did we mention we provide a ton of benefits ?). Connecting great people with great companies is what we do best, and our employment opportunities span a wide variety of workstyles, skill levels, and industries around the world.

Kelly Services is proud to be an Equal Employment Opportunity and Affirmative Action employer. We welcome, value, and embrace diversity at all levels and are committed to building a team that is inclusive of a variety of backgrounds, communities, perspectives, and abilities. At Kelly, we believe that the more inclusive we are, the better services we can provide. Requests for accommodation related to our application process can be directed to Kellys Human Resource Knowledge Center.
Kelly complies with the requirements of Californias state and local Fair Chance laws. A conviction does not automatically bar individuals from employment.
Posted: 2022-09-16 Expires: 2022-10-17

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REMOTE Regulatory Drug Operations Manager

Kelly Services
San Francisco, CA 94103

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