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Regulatory Operations Associate Jobs in California

Kelly Services

Marketing Operations Associate

Irvine, CA · Hybrid

$43/hr

Marketing Operations Associate Duration: 9+ Months on w2 Pay Rate: $43/hr. Shift: 1st 9AM-5PM PST ... Interface with Editorial, Production and Regulatory to assist with system execution of submission ...

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Regulatory Operations Associate information

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How much do regulatory operations associate jobs pay per hour?

As of Aug 30, 2026, the average hourly pay for regulatory operations associate in California is $25.90, according to ZipRecruiter salary data. Most workers in this role earn between $17.55 and $29.90 per hour, depending on experience, location, and employer.

What is a regulatory operations associate?

Regulatory Operations Associates are professionals who support the preparation, submission, and management of documents required by regulatory agencies for product approvals, especially in industries like pharmaceuticals, biotechnology, and medical devices. They ensure that submissions comply with legal and regulatory standards, track submission timelines, and often use specialized software for document management. Their work is crucial for maintaining compliance and facilitating smooth communication between their company and regulatory authorities. Additionally, Regulatory Operations Associates may coordinate with cross-functional teams to gather necessary documentation and maintain up-to-date records.

How does a regulatory operations associate typically collaborate with cross-functional teams within an organization?

Regulatory Operations Associates frequently work alongside regulatory affairs, quality assurance, clinical, and legal teams to ensure that all submissions and documentation comply with industry standards and governmental regulations. They coordinate the collection, formatting, and timely submission of regulatory documents, often acting as a liaison between departments to resolve any discrepancies or gather necessary information. Effective communication and organization are key, as the role requires balancing multiple deadlines and adapting to evolving requirements set by regulatory authorities.

What are the key skills and qualifications needed to thrive as a regulatory operations associate, and why are they important?

To excel as a Regulatory Operations Associate, you generally need a background in life sciences or a related field, strong attention to detail, and experience with regulatory documentation processes. Familiarity with electronic document management systems (EDMS), eCTD publishing tools, and knowledge of regulatory submission standards are typically required. Excellent organizational skills, communication, and the ability to manage multiple deadlines help candidates stand out. These competencies ensure accurate, timely regulatory submissions and compliance, which are critical for product approvals and organizational success.

What is the difference between Regulatory Operations Associate vs Regulatory Affairs Specialist?

AspectRegulatory Operations AssociateRegulatory Affairs Specialist
Required CredentialsBachelor's degree, familiarity with regulatory processesBachelor's degree, often with certifications in regulatory affairs
Work EnvironmentSupportive regulatory teams, administrative tasksStrategic planning, compliance management
Employer & Industry UsagePharmaceutical, biotech, healthcare companiesPharmaceutical, medical device, biotech sectors
Common Search & ComparisonYesNo

The Regulatory Operations Associate typically handles administrative and operational support within regulatory teams, focusing on document management and submission processes. In contrast, the Regulatory Affairs Specialist is more involved in strategic compliance, ensuring products meet regulatory standards. Both roles are essential in regulated industries like pharma and biotech, but they differ in scope and responsibilities.

What are the most commonly searched types of Regulatory Operations jobs in California?

The most popular types of Regulatory Operations jobs in California are:

What are popular job titles related to Regulatory Operations Associate jobs in California?

For Regulatory Operations Associate jobs in California, the most frequently searched job titles are:

What job categories do people searching Regulatory Operations Associate jobs in California look for?

The top searched job categories for Regulatory Operations Associate jobs in California are:

What cities in California are hiring for Regulatory Operations Associate jobs?

Cities in California with the most Regulatory Operations Associate job openings:

Regulatory Operations Associate jobs near you
Infographic showing various Regulatory Operations Associate job openings in California as of August 2026, with employment types broken down into 82% Full Time, 15% Part Time, and 3% Contract. Highlights an 93% Physical, 3% Hybrid, and 4% Remote job distribution, with an average salary of $53,874 per year, or $25.9 per hour.

Associate Regulatory Operations Director (Dossier Planner)

Alameda, CA • On-site

Exelixis
Biotechnology Research and Development • 501 - 1,000 employees
Learn more about Exelixisexternal

Full-time

Medical, Dental, Vision, Life, Retirement, PTO

Re-posted 4 days ago

Job description

SUMMARY/JOB PURPOSE:

The Associate Regulatory Operations Director is responsible for overseeing submission activity for the company's submission portfolio, with first line accountability for managing the submission forecast and ensuring proper staffing for upcoming submissions. She/he utilizes in-depth knowledge of global regulatory submission requirements and works collaboratively within Regulatory Affairs and other cross-functional departments in providing guidance towards achieving department application filing objectives , identifying areas of concern that are impacting submission timelines, drive process efficiencies and overall operational effectiveness for timely and high-quality regulatory submissions. This role also provides oversight and guidance on the Veeva RIM suite and identify best practices for effective implementation.

ESSENTIAL DUTIES AND RESPONSIBILITIES:

  • Oversees the planning of all regulatory submissions (INDs, NDAs, BLAs, supplemental applications, etc.) in electronic format.

  • Accountable for the oversight of regulatory submission processes and best practices, bringing clarity to submission timelines and deliverables.

  • Works collaboratively with Regulatory Affairs and contributing cross-functional team members in order to create and maintain global regulatory submission project plans, manages deliverable timelines and activities, ensures alignment on roles and responsibilities, and that any issues, risks, or impact due to changes in strategy and/or timelines are assessed quickly throughout the submission process ensuring transparency of submission status to key stakeholders and management.

  • Leads a cross-functional team within Exelixis to explore submission process optimization.

  • Develops submission planning best practices and implementation of major submission timelines.

  • Partners with Vice President, Regulatory Operations in the development and implementation of Department best practices and ways of working.

  • Provides key insight to identify IT solutions to enhance Regulatory Operations systems (i.e., Project planning tools, Veeva RIM)

  • Participates in the writing of regulatory processes (SOPs, work instructions, and/or internal guidelines) and other departmental initiatives to improve standards and systems internally.

  • Mentors/instructs members of the Regulatory Operations team on Best Practices for submission planning.

  • Reviews and interprets regulatory guidelines.

SUPERVISORY RESPONSIBILITIES:

  • None.

EDUCATION/EXPERIENCE/KNOWLEDGE & SKILLS:

Education/Experience:

  • Bachelor's degree in related discipline and a minimum of eleven years of related experience; or,

  • Master's degree in related discipline and a minimum of nine years of related experience; or,

  • PhD degree in related discipline and a minimum of five years of related experience; or,

  • Equivalent combination of education and experience.

Experience/The Ideal for Successful Entry into Job:

Knowledge/Skills:

  • Develops and manages plans within established timelines and balances commitments to complete multiple activities and achieve results. Takes pride in delivering high quality work.

  • Applies wide knowledge of the regulatory framework and industry practices to develop innovative approaches and complete 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 groups of departmental colleagues.

  • Strong interpersonal skills and ability to accommodate differing views to actively support the development of an agreed upon resolution.

  • Manages effectively performing teams to achieve common objectives. Engages internal stakeholders to establish productive collaborative relationships.

  • Applies knowledge of organizational goals and objectives and demonstrates skill and insight in gathering, analyzing and applying key information to solve problems.

  • Leads self and others; acts with integrity and builds trust with colleagues to contribute to accomplishing team objectives.

JOB COMPLEXITY:

  • Capable of managing the execution of multiple tasks.

  • Ensures appropriate prioritization and execution for area of responsibility.

  • Proactively anticipates, prioritizes and resolves task-related challenges.

  • Designs and implements solutions to address task-related challenges, taking into consideration the broader impact.

WORKING CONDITIONS:

  • Travel approximately 20%

DISCLAIMER

The preceding job description has been designed to indicate the general nature and level of work performed by employees within this classification. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities and qualifications required of employees assigned to the job.

We are an Equal Opportunity Employer and do not discriminate against any employee or applicant for employment because of race, color, sex, age, national origin, religion, sexual orientation, gender identity, status as a veteran, and basis of disability or any other federal, state, or local protected class.

#LI-MB1

Our compensation reflects the cost of labor across severalU.S. geographic markets, and we pay differently based on those defined markets. The base pay range for this positionis $157,500 - $222,500 annually. The base pay range may take into account the candidate's geographic region, which will adjust the pay depending on the specific work location. The base pay offered will take into account the candidate's geographic region, job-related knowledge, skills, experience and internal equity, among other factors.In addition to the base salary, as part of our Total Rewards program, Exelixis offers comprehensive employee benefits package, including a 401k plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts. Employees are also eligible for a discretionary annual bonus program, or if field sales staff, a sales-based incentive plan. Exelixis also offers employees the opportunity to purchase company stock, and receive long-term incentives, 15 accrued vacation days in their first year, 17 paid holidays including a company-wide winter shutdown in December, and up to 10 sick days throughout the calendar year.

If you have a disability and need an accommodation in relation to the recruiting process, please email us at: ApplicantAccommodations@exelixis.com.


WORKING CONDITIONS:

Our office is a modern space that fosters collaboration and creativity. Teams work closely together, sharing ideas and solutions in a supportive atmosphere. We provide all necessary equipment, including dual monitors and ergonomic chairs, to ensure a comfortable workspace.


DISCLAIMER:
The preceding job description has been designed to indicate the general nature and level of work performed by employees within this classification. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities and qualifications required of employees assigned to the job.


We are an Equal Opportunity Employer and do not discriminate against any employee or applicant for employment because of race, color, sex, age, national origin, religion, sexual orientation, gender identity, status as a veteran, and basis of disability or any other federal, state or local protected class.

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