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10 days old

Associate Director - Regulatory

Kelly Services
Gaithersburg, MD 20898
Kelly Services is currently seeking a Associate Director - Regulatory in Gaithersburg, MD (working remotely is an option) to work a contract assignment of 12 months for one of our top clients. Kelly is a full service workforce solutions provider to 98% of the Fortune 100 companies. We provide employment to more than 700,000 people annually and we deal with some of the largest and best companies both nationally and locally.


**Primary Responsibilities of the** Associate Director - Regulatory **includes:**


+ Ideal candidates will have experience with regulatory assessment of changes/change control; developing submission strategy (not supporting); working with external partners; and creating/writing/supporting DMFs.


Description:


+ You will be responsible for leading CMC regulatory strategy development and implementation that incorporates risk identification and contingency planning for assigned post-approval and global marketing authorization applications for biologic products (particularly monoclonal antibodies and/or vaccines).

+ This role will actively partner with our Manufacturing Operations group to establish alignment of product regulatory strategies and to communicate regulatory CMC requirements to team members both internally and externally. This role also specifically provides support to internal RegCMC Commercial Biologics Staff and external partners who use the company as a contract manufacturing organization.

+ Activities include Drug Master File submission and maintenance; submitting information directly to health authorities to protect the company's IP/IK; non-conformance support and assessment; BPDR support as needed; and other tasks related to supporting the company's external partners (aka 3rd party support).

+ Establishes and develops external relationships with key Regulatory stakeholders, leveraging these to maintain competitive advantage.

+ Assess change controls for impact to DMFs and external partners.


Responsibilities:


+ Preparation of regulatory submissions, including compilation of submission documentation, and preparation of regulatory components (forms, cover letter, etc). The focus of this position is Drug Master Files for sites and their support of our third party users.

+ Establishment of submission timelines and management of information required to meet submission target dates.

+ Responsible for upload, retrieval, and maintenance of documents for electronic submissions using the appropriate software and applications.

+ Maintenance and filing of regulatory related documentation and track regulatory commitments, submission requests, timelines, and deliverables.

+ Research relevant information, regulations, and guidance from applicable regulatory agencies.

+ Interact with cross-functional groups and attend team meetings as necessary to support submission development and project coordination.

+ Review submission documentation for accuracy and compliance with applicable regulations and guidelines as required.

+ Proactively identify potential issues and alert supervisor for further action.


**Additional Information:**


+ Contract assignment, duration 12 months.

+ Work schedule: full-time, first shift.


**Kelly Temporary Employee Perks:**


+ Group medical, prescription, vision, dental, life, and short-term disability insurance options that are available for purchaseand the coverage is portable*

+ Service bonus plan and Holiday pay plan, if qualified

+ Weekly electronic pay options

+ Free online training campus available

+ Exclusive online employee community

+ Corporate discounts


**Apply Now!**


This position is recruited for by a remote Kelly office, not your local Kelly branch. To be considered for this position you must submit your resume to the Scientific Recruiter listed below:


Please email your resume directly to Sandy at: Sanm174@KellyServices.com [reference BH Job #3429907]


Thank you for your interest in the assignment.


**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/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 is an equal opportunity employer committed to employing a diverse workforce, including, but not limited to, minorities, females, individuals with disabilities, protected veterans, sexual orientation, gender identity. Equal Employment Opportunity is The Law. (https://www.dol.gov/ofccp/regs/compliance/posters/ofccpost.htm)
Posted: 2021-04-05 Expires: 2021-05-06

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Associate Director - Regulatory

Kelly Services
Gaithersburg, MD 20898

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