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1+ months

Regulatory Affairs Manager

Kelly Services
Sunnyvale, CA 94086
Kelly Services has been providing outstanding employment opportunities to the most talented individuals in the marketplace. We are proud to offer a long-term temporary opportunity to work as a **Regulatory Affairs** **Manager** at a prestigious Fortune 500 company working in **Sunnyvale.**


**Important information:** This position is recruited for by a remote Kelly office, not your local Kelly branch. To be considered for this position, you must use the Submit Resume button to submit your resumes. If you have questions about the position, you may contact the recruiter for this position ( Brooke.Schoen@kellyservices.com ) however your resume must be received via the Submit Resume button included within.


**Job Title: Regulatory Affairs Manager**


**Pay: $82.75 per hour**


**Description**


The Manager, under the accountability of the Director, Regulatory Affairs, helps lead teams by providing regulatory strategy and support to global development. He/she is expected to help support teams and efforts around major filing activities and Health Authority (HA) interaction and meetings, attend and provide regulatory support to other departments, project teams and committees. Organize/manage submissions to health authorities, including IND/CTAs, IND/CTA amendments, NDAs/MAAs, Orphan Drug Application, Breakthrough Applications, safety reports, pre-meeting packages, and NDA post-approval submissions. This position may have direct interaction with FDA representatives.


Key Accountabilities/Core Job Responsibilities:

Represents RA at project team meetings and manages/oversees regulatory workflow between departments as well as CROs as required at the study team level for management of CTAs, IMPDs.

o Serve as primary regulatory contact for CROs and lead regulatory team in development of CTA timelines, responses to HA queries and general oversight to CRO regulatory team.

Lead and facilitate US filing activities IND/NDA submissions including but not limited to orphan drug designation, preparation and submission of meeting requests/briefing books and response to information requests

Provide strategic input on regulatory filing documents (e.g., eCTD Module 1 label, Module 2 summaries, integrated summary documents, statistical analysis plans and clinical study reports).

Oversee development of dossier filing plan and associated timelines with regulatory operations lead

Provide oversight to filing and study teams regarding overall regulatory strategy to ensure compliance with global HA regulations/guidelines and company SOPs to ensure successful and high quality regulatory applications

Direct interaction with FDA as point of contact for IND/NDA. Build and maintain excellent relationships with FDA personnel

Lead development and authoring internal procedures and company SOPs ensuring compliance with existing regulations and guidelines.

Execute, independently or with very limited guidance and supervision, product development and regulatory strategies regarding submissions and/or compliance issues

Additional Functions:

o Foster cross functional teamwork and improve intra-/inter-departmental communications

o Collaborate with external parties, i.e., partner companies and investigator-sponsors, on regulatory strategy for IND and NDA filings

o Supervise regulatory staff and mentor/train RA associates in carrying out responsibilities. Coordinate RA associates activities and career development

o Position will regularly interact with all departments and all levels within a department

o Position may have direct reports



Qualifications:

Specialized knowledge of regulatory activities including but not limited to submissions to HAs, including NDA/BLA/MAA, INDs/CTAs, IND/CTA amendments, safety reports, pre-meeting packages, and post-approval submissions

Ability to understand clinical and pre-clinical study results, to help in its interpretation for regulatory positions and strategy

Ability to work either independently with minimal direction separately and within project teams, committees, etc. to attain group goals

Ability to creatively complete activities within the allotted, sometimes aggressive, time schedules

Thorough working knowledge and understanding (application of knowledge/experience) of FDA/EMA guidance and regulations, especially for drug therapeutics

Ability to learn and assimilate scientific information

Flexible attitude with respect to work assignments, and willingness to learn



Experience:

o B.S., advanced degree in life sciences preferred (PhD, PharmD, NP/PA, MD, MS, MPH) Masters in Regulatory Science

o Minimum of five years pharmaceutical/biotechnology industry experience, with relevant U.S. regulatory experience including hands-on knowledge of all aspects of the drug development process

Strong scientific background and experience in critical review and interpretation of scientific/clinical data.

Experience/competence in writing regulatory documents (e.g., meeting requests/briefing book activities).

Prior work experience in hematology/oncology highly desirable.

Ability to interpret FDA/EMA regulations, guidelines, policy statements, etc., and apply to the specific situation at hand.

Strong interpersonal skills and the ability to deal effectively with a variety of personnel cross-functionally.

Ability to guide, train, supervise and mentor personnel within regulatory affairs department.



Top 3-5 skills requirements:


o Minimum of five years pharmaceutical/biotechnology industry experience, with relevant U.S. regulatory experience including hands-on knowledge of all aspects of the drug development process.

o Experience/competence in writing regulatory documents (e.g., meeting requests/briefing book activities).

o Strong interpersonal skills and the ability to deal effectively with a variety of personnel cross-functionally.

o Proficient with MS office, PowerPoint, Agile

o Tech Savvy

o Extremely detailed oriented


Work Schedule: M-F

Ability to work remotely a couple days a week after going back on site


**We invite you to bookmark our Web site and encourage you to review it regularly for new opportunities worldwide:** www.kellyservices.com **.**


**_Kelly Services is a U.S.-based Fortune 500 company. With our global network of branch locations, we are uniquely positioned to provide our customers with international staffing support and our employees with diverse assignments around the world._**


**Kelly Services is an Equal Opportunity Employer**


**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: 2021-04-28 Expires: 2021-06-28

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Regulatory Affairs Manager

Kelly Services
Sunnyvale, CA 94086

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