Director Regulatory Operations
Director Regulatory Operations
Posted on :
11-04-2025
Employer Active
1 Vacancy
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Monthly Salary
$ 180735 - 223260
Vacancy
1 Vacancy
Posted on :
11-04-2025
Job Description
IDEAYA Biosciences (NASDAQ: IDYA) is a public clinicalstage precision medicine oncology company committed to the discovery development and commercialization of targeted therapeutics for patient populations with high unmet clinical needs. Our approach integrates extensive capabilities in identifying and validating translational biomarkers with small molecule drug discovery to select patient populations most likely to benefit from the therapies we are developing. We have developed an industry leading platform and pipeline in precision medicine by applying these capabilities across multiple approaches such as direct targeting of oncogenic pathways and synthetic lethality which represents an emerging class of precision medicine targets. We believe this diversified approach will enable us to deliver the right medicine to the right patient to drive a more robust clinical response. IDEAYA has established strategic collaborations with GSK Merck Pfizer and Gilead but whollyowns or controls its four mostadvanced clinical programs and we are committed to building a bestinindustry organization to deliver our precision medicines to the people who need them.
When youre at IDEAYA you will be in the midst of brilliant minds working on precision medicine therapies to help cancer patients. We are passionate and committed about being on the forefront of oncology medicine which means we all have a high internal drive that is at the very core of every person at IDEAYA. We are inquisitive ask deep questions and are datadriven innovators who like to collaborate and use teamwork to move science forward. For more information please see www.ideayabio.
Notice to Agencies and Recruiters: All open positions and candidate activity are strictly managed through Human Resources. Please note that our policy is that recruiters do not contact employees/hiring managers directly to solicit business and/or present candidates. Submission of unsolicited resumes prior to an agreement set in place between the Human Resources Department and the recruiting agency will not create any implied obligation. Please note that failure to comply with this request will be a factor in developing a professional relationship with IDEAYA Bio. Inquiries regarding developing a recruiting relationship with us may be directed to
Position Summary:
We are seeking an experienced and strategic Director of Regulatory Operations to lead and oversee global regulatory submission processes electronic publishing and regulatory systems management with a particular focus on Veeva Regulatory Information Management (RIM) systems.
This leadership role will drive regulatory submission excellence process optimization and system innovation ensuring the timely of regulatory filings across multiple health authorities including FDA EMA Health Canada MHRA and other global agencies. The ideal candidate will be a subject matter expert in Veeva RIM with a strong background in electronic Common Technical Document (eCTD) submissions global regulatory compliance and document management best practices.
This position is based in our South San Francisco headquarter offices and required to be onsite four days per week per our company policy.
What youll do:
- Regulatory Operations Leadership & Strategy
- Lead and strategically oversee the global regulatory submission function ensuring compliance and operational excellence.
- Develop and execute submission strategies for INDs NDAs BLAs and postapproval submissions.
- Serve as the Veeva RIM subject matter expert overseeing system implementation maintenance and optimization.
- Ensure Veeva RIM system integration with regulatory workflows submission publishing tools and document management platforms.
- Drive process automation within Veeva RIM to enhance submission tracking metadata management and regulatory reporting.
- Develop best practices and training programs to maximize team proficiency in Veeva RIM and regulatory technology tools.
- Oversee regulatory submission publishing document formatting and electronic submission management using Veeva RIM and eCTD software.
- Ensure electronic document integrity version control and submission readiness within Veeva RIM and supporting platforms.
- Identify opportunities for streamlining global regulatory workflows improving compliance and reducing submission cycle times.
- Stay updated on emerging regulatory technology trends ensuring the organization leverages cuttingedge digital solutions.
- Partner with Regulatory Affairs Quality Clinical CMC and Commercial teams to align submission deliverables and regulatory strategies.
- Lead crossfunctional regulatory submission planning meetings ensuring clarity on roles responsibilities and expectations.
- Establish and maintain bestinclass regulatory submission workflows ensuring operational efficiency and regulatory compliance.
- Support regulatory inspections audits and health authority interactions providing leadership in submission documentation and compliance.
Veeva RIM System Ownership & Optimization
Regulatory Systems & Process Optimization
CrossFunctional Collaboration & Compliance
Requirements:
- Education:
- Bachelors degree in Life Sciences Pharmacy Chemistry Regulatory Affairs or a related field (Advanced degree preferred: MS PhD or MBA).
- 1015 years of experience in Regulatory Operations within the pharmaceutical or biotechnology industry.
- Extensive experience with Veeva RIM systems including system implementation. Configuration and optimization a plus.
- Deep expertise in global regulatory submissions (eCTD FDA EMA ICH guidelines).
- Strong background in electronic document management metadata tracking and regulatory publishing tools.
- Experience with submission archives regulatory compliance tracking and system validation processes
- Strategic thinker with a proactive approach to problemsolving and regulatory innovation.
- Excellent leadership and team management skills.
- Strong communication and stakeholder engagement skills collaborating effectively with internal teams and regulatory agencies.
- Detailoriented highly organized and capable of managing multiple global submissions simultaneously.
Experience:
Soft Skills:
$180735 $223260 a year
At IDEAYA Biosciences we care about our employees and strive to provide a marketcompetitive total rewards package including base pay an annual performance bonus company equity and generous health and wellbeing benefits. The expected salary range for this role that is based in our South San Francisco California office is $180735 $223260.
The final salary offered to a successful candidate will depend on several factors that may include but are not limited to the office location where this open position is located the final candidates experience within their profession experience in the disease areas we are striving to make an impact in as a company length of time within the industry educational background and performance during the interview process.
The Company complies with all laws respecting equal employment opportunities and does not discriminate against applicants with regard to any protected characteristic as defined by federal state and local law. This position requires you to work onsite at the Companys facilities with partial workfromhome flexibility and the Company requires that all employees working in its facilities be fully vaccinated (except as required by applicable law). Therefore this position requires you to be fully vaccinated from COVID19 subject to reasonable accommodations for medical or religious reasons and/or as otherwise required by applicable law. The Company considers you fully vaccinated once 14 days have passed since you received either the second dose in a twodose COVID19 vaccine series or a singledose COVID19 vaccine. The vaccine must have been FDA approved have emergency use authorization from the FDA or for persons fully vaccinated outside of the U.S. be listed for emergency use by the World Health Organization.
Total Rewards:
Along with our inspiring mission and highly collaborative and inclusive environment IDEAYA offers a competitive total rewards package that reflects our payforperformance philosophy where employees are eligible to be considered for meritbased salary increases company discretionary shortterm incentive plan participation and company discretionary stock option awards (based on board approval). Our comprehensive benefits package includes but is not limited to medical/dental/vision coverage 100 company paid for employees and 90 company paid for dependents) 401k ESPP and wellness programs.
IDEAYA is an equal opportunity employer. In accordance with applicable law IDEAYA does not discriminate in hiring or otherwise in employment based on race color religion sex national origin age marital or veteran status disability sexual orientation or any other legally protected status. EOE/AA/Vets.
Required Experience:
Director
Employment Type
Full-Time
Key Skills
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