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26 days old

Regulatory Affairs Manager (Oncology) - San Diego, CA

Kelly Services
San Diego, CA 92108
**Regulatory Affairs Manager (Oncology) - San Diego, CA**



We have an exciting opportunity for a **Regulatory Affairs Manager** to join one of our top clients in San Diego, CA who focuses on Oncology Therapeutics



The **Regulatory Affairs Manager** will be able to work in a matrix environment and possess the credentials to be the US and global lead in providing both strategic input and day to day guidance for the projects assigned.



**Relocation package availalbe for right candiate!**



**Duties and Responsibilities:**




+ Support regulatory teams ensuring the project assigned progresses from IND stage to launch within company agreed timelines.

+ Ensure regulatory compliance with relevant regulations and effectively managing timely submissions to the appropriate regulatory authorities

+ Manage the preparation of applications and subsequent regulatory documents, pre and post approval in accordance with agreed timeframes

+ Ensure submission-readiness of all regulatory documents related to the project

+ Ensure that documents to be submitted to the health authorities are compliant with eCTD submission requirements.

+ Format documents

+ Determine risk assessment with senior regulatory leadership and implement those regulatory strategies for products in pre and post-approval stages.

+ Build long term effective relationships and open communication with cross functional teams in order to provide accurate information and timeframes.

+ Participate in R&D meetings to discuss project issues and develop priorities to produce clear project plans.

+ Develop and maintain a positive working rapport with the regulatory agencies

+ Develop and maintain standard operating procedures or local working practices

+ Maintain current knowledge of relevant regulations, including proposed and final rules



**Minimum Requirements:**




+ BA/BS and 8 years, MA/MS and 6 years, or PhD/PharmD and 3 years of relevant US regulatory (FDA) / drug development experience

+ Good communication skills both oral and written

+ Organizational skills detail oriented and can deal with frequent changes in product activity

+ Strong knowledge of eCTD elements and structure

+ Strong team player that has a customer service approach and is solution oriented

+ Must be able to work on multiple projects simultaneously and demonstrate organizational, prioritization, and time management proficiencies

+ Excellent interpersonal, verbal and written communication skills are essential in this collaborative work environment

+ High level of proficiency in relevant software (i.e., MS Word, MS Office or similar systems, Adobe)

+ Expertise with templates and formatting tools

+ High energy level and a positive outlook coupled with the requisite can do attitude and a willingness to do what it takes to achieve personal and organizational goals and overcome obstacles

+ Ability to adapt in a constantly evolving environment

+ Self-motivated with a strong sense of ownership in areas of responsibility

+ High degree of professionalism, ethics and integrity

+ Comfortable in a fast-paced small company environment with minimal direction and able to adjust workload based upon changing priorities



**APPLY TODAY! Questions? Email Kevin at kevin.lau@kellyscientific.com or call Kevin at 623-688-2142**






**Why Kelly** **** **?**



Kelly Science & Clinical is your connection to premier scientific and clinical companies looking to hire talented people just like you. Every day, we match science professionals with dream jobs that fit their skills and interestsits the way we think job searching should be. Nearly 100 percent of our science recruiters have a professional background/education in science, so we know a thing or two about the science market and how to get you 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/non-traditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live. 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 is an equal opportunity employer committed to employing a diverse workforce and providing accommodations for people with disabilities in all parts of the hiring process as required under its Employment Accommodation Policy. Kelly will work with applicants to meet accommodation needs that are made known to Kelly in advance.

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Posted: 2020-07-20 Expires: 2020-09-07

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Regulatory Affairs Manager (Oncology) - San Diego, CA

Kelly Services
San Diego, CA 92108

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