Regulatory Affairs and Compliance Director Job Listing at Kelly Services in Alameda, CA (Job ID 9546690)

Description

Regulatory Affairs Policy, Intel, & Compliance Director

• Direct Hire
• Location: Alameda, CA or King of Prussia, PA
• The base pay range: $183,000 - $260,000 annually. The base pay offered will consider the candidate's geographic region, job-related knowledge, skills, experience and internal equity, among other factors.

SUMMARY/JOB PURPOSE:
Responsible for gathering and interpreting global regulatory intelligence to inform policy and practices. Ensures timely preparation and completion of action plans to maintain processes and procedures, in response to changes in regulatory requirements. Oversees Regulatory Affairs procedural documents in the Quality Management System. Establishes processes and measures to monitor conformance with Regulatory Affairs procedures and compliance with regulatory requirements.

ESSENTIAL DUTIES AND RESPONSIBILITIES:

• Monitor the external regulatory environment to identify emerging intelligence with relevance.
• Establish formal and informal networks to keep up to date with regulatory intelligence and interpretation.
• Interpret regulatory intelligence to assess the impact on the client and advise Regulatory Affairs leadership accordingly.
• Lead Regulatory Affairs action planning of updates to policies, processes and procedures.
• Monitor the completion of regulatory intelligence related action plans.
• Establish cross-functional relationships and an internal network to plan actions resulting from new regulatory intelligence.
• Business owner for the enterprise regulatory intelligence system.
• Coordinate activity amongst all Regulatory Affairs groups and with the clients Quality Assurance, to establish appropriate quality procedures, in the form of policies, standard operating procedures and work instructions.
• Establish process and measures to ensure Regulatory Affairs conformance with quality procedures.
• Establish process and measures to ensure Regulatory Affairs compliance with regulatory requirements.

EDUCATION/EXPERIENCE/KNOWLEDGE & SKILLS:

• Bachelor's degree in related discipline and a minimum of thirteen years of related experience; or,
• Master's degree in related discipline and a minimum of eleven years of related experience; or,
• PhD degree in related discipline and a minimum of eight years of related experience; or,
• Equivalent combination of education and experience.

Experience/The Ideal for Successful Entry into Job:

• Develops and manages plans, establishes timelines, sets standards for performance. Proactively balances commitments and overcomes challenges to complete multiple activities and achieve results. Takes pride in delivering high quality work.
• Applies extensive knowledge of the regulatory framework, industry drivers and practices to develop innovative approaches and manage complex work.
• Demonstrates clear and effective verbal and written communication. Provides timely and appropriate information updates. Speaks clearly and confidently in one-to-one situations and effectively presents information to cross-functional groups of colleagues.
• Strong interpersonal skills and ability to accommodate differing views to influence an agreed upon resolution.
• Manages effectively performing teams, facilitates team alignment and achievement of common objectives. Engages internal and external stakeholders to establish productive collaborative relationships.
• Applies knowledge of organizational goals and objectives and demonstrates advanced skill and insight in gathering, analyzing and applying key information to solve problems. Provides regulatory expertise to cross-functional teams. Understands longer term consequences of decisions and actions.
• Effectively leads and manages a team, acting with integrity to build trust and execute on team objectives that contribute to departmental goals.

JOB COMPLEXITY:

• Capable of proactively assessing workload, trends, tasks and priorities for area of responsibility.
• Plans and executes multiple activities.
• Considers alternative methods and contingency plans to avoid potential issues.
• Designs and implements solutions to address project level challenges, taking into consideration the broader impact.
• Travel approximately 15%

#EX2BIO24
 

As part of our promise to talent, Kelly supports those who work with us through a variety of benefits, perks, and work-related resources. Kelly offers eligible employees voluntary benefit plans including medical, dental, vision, telemedicine, term life, whole life, accident insurance, critical illness, a legal plan, and short-term disability. As a Kelly employee, you will have access to a retirement savings plan, service bonus and holiday pay plans (earn up to eight paid holidays per benefit year), and a transit spending account. In addition, employees are entitled to earn paid sick leave under the applicable state or local plan. Click here for more information on benefits and perks that may be available to you as a member of the Kelly Talent Community.

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 world's most critical challenges. Every day, we match science professionals with dream jobs that fit their skills, interests, and career goals—it's 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

Work changes everything. And at Kelly, we're obsessed with where it can take you. To us, it's about more than simply accepting your next job opportunity. It's the fuel that powers every next step of your life. It's the ripple effect that changes and improves everything for your family, your community, and the world. Which is why, here at Kelly, we are dedicated to providing you with limitless opportunities to enrich your life—just ask the 300,000 people we employ each year.

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 Kelly's Human Resource Knowledge Center. Kelly complies with the requirements of California's state and local Fair Chance laws. A conviction does not automatically bar individuals from employment. Kelly participates in E-Verify and will provide the federal government with your Form I-9 information to confirm that you are authorized to work in the U.S.

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