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18 days old

Senior Regulatory Affairs Manager - Irvine, CA

Kelly Services
Irvine, CA 92604
**Senior Regulatory Affairs Manager - Irvine, CA**


**RESPONSIBILITIES:**


Planning:


+ Assists in company Standard Operating Procedures (SOPs) development and review.

+ Identifies emerging regulatory issues.

+ Provides regulatory input to product lifecycle planning.

+ Continues to revisit and compare regulatory outcomes with initial product concepts to make recommendations on future actions.

+ Assists in the development of regulatory strategy and updates strategy based upon regulatory changes in conjunction with other related teams.

+ Determines trade issues to anticipate regulatory obstacles.

+ Provides regulatory assistance during the ANDA/NDA submission and approval process.

+ Participates in risk-benefit analysis for regulatory compliance.


Pre-Market:


+ Assists in reviewing documents for regulatory compliance necessary for the acceptability of quality documentation for submission filing.

+ Assists in developing pre-approval compliance activities during manufacturing of submission batches.

+ Performs label development and reviews for compliance.

+ Monitors impact of changing regulations on submissions.

+ Monitors applications under regulatory review for changes that affect Nexgen products.

+ Monitors and submits applicable reports to regulatory authorities as required.

+ Determines regulatory filing strategies for proposed preclinical, clinical and manufacturing changes.

+ Negotiates and interacts with regulatory authorities during the development and reviews processes to ensure submission approval as required.


Post-Market:


+ Maintains annual licenses, registrations, listings and patent information as required.

+ Ensures compliance with product post-marketing approval requirements, annual reports, drug listings, labeling, pharmacopeia changes (pre and post approval), etc.

+ Assesses external communications relative to regulations and regulators.

+ Reviews regulatory aspects of contracts with customers.

+ Submits and reviews change controls to determine the level of change and consequent submission requirements.

+ Analyzes the input of product changes to current product submissions.

+ Contributes to the resolution of the regulation issue and regulatory metrics as required.

+ Ensures product safety issues and product-associated events are reported to regulatory agencies.

+ Provides regulatory input for product recalls and recalls communications.

+ Assists in cGMP and PV inspections as needed.

+ Assists in preparing and submission of ICSRs, PADERS etc.

+ Other related duties as required.


**QUALIFICATIONS:**


+ Bachelor's degree in science (biology, chemistry, microbiology, and pharmacy), math or engineering fields.

+ 10+ years of experience in a regulatory function within pharmaceuticals (preferred) or medical products; experience in quality assurance, compliance or related area may be considered; or equivalent combination of education and experience.

+ Certification such as RAC from the Regulatory Affairs Professionals Society preferred.

+ Hands-on experience in supporting and maintaining NDA's and ANDAs.

+ Experience with electronic regulatory submissions.

+ Thorough knowledge of U.S. regulatory environment required; knowledge of international environment is a plus.

+ Excellent verbal and written communication skills.

+ Able to handle multiple high priority assignments.

+ Proven technical aptitude.

+ Advanced technical writing skills and acute attention to detail.

+ Able to build rapport at all levels of the organization as well as with external contacts.


**_For immediate consideration apply today!_**


**_Questions? Please reach out to Dustin at DUSG877@kellyservices.com_**


**_\#TJP2021_SPEC_**


**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: 2021-06-04 Expires: 2021-07-05

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Senior Regulatory Affairs Manager - Irvine, CA

Kelly Services
Irvine, CA 92604

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