Search for Associate Director roles in Commercial Regulatory Operations in Redwood City, with a focus on the pharmaceutical industry, requiring 8+ years of experience, and knowledge of Veeva Vault.

Okay, I've searched for Associate Director roles in Commercial Regulatory Operations within the pharmaceutical industry in Redwood City, requiring 8+ years of experience and knowledge of Veeva Vault. I found 25 positions that match your criteria.

Associate Director

Redwood City, CA

pharmaceutical

8 years + Experience

Veeva Vault

Can you help me to analyze the job description and company culture?

Sure. Here's the analysis:

Job Analysis:

The Associate Director of Commercial Regulatory Operations is fundamentally tasked with ensuring that promotional and non-promotional materials comply with regulatory standards in a fast-paced environment focused on the launch of new products. This involves managing the end-to-end review process which requires not only meticulous attention to detail but also advanced organizational capability to coordinate between multiple cross-functional teams, including Regulatory, Legal, Medical, and Commercial divisions. Key responsibilities such as scheduling CRT meetings and managing document workflows through platforms like Veeva highlight the role's emphasis on logistics and operational effectiveness. Success in this role may involve meeting project deadlines while navigating the complexities of regulatory compliance, as well as fostering a culture of collaboration among diverse stakeholders. The ideal candidate will face challenges related to ambiguity and rapid change as the company expands its product offerings, necessitating a proactive and adaptable problem-solving approach. Overall, success will be judged not only by the efficiency of the review process but also by the ability to influence and communicate effectively across teams in a highly regulated industry.

Company Analysis:

Corcept Therapeutics occupies a specialized niche within the pharmaceutical industry, focusing on cortisol modulation to address serious health conditions. As a leader in this field, anchored by their innovative products like Korlym®, Corcept is positioned at the forefront of scientific discovery, which suggests an environment that values research, persistence, and patient-centered outcomes. The culture seems to be mission-driven, placing high importance on collaboration and compliance, reflecting the standards necessary in the pharmaceutical landscape. This role will likely fit within a structure that values agility and rapid product launches, thereby requiring an individual who thrives in dynamic settings while aligning with the organization's overarching goals of advancing therapeutic possibilities. With a commitment to unlocking the potential of cortisol modulation, this position is strategic—not merely operational—as it directly contributes to the company's ability to expand its market presence and enhance treatment options for patients, thus offering significant long-term potential for a candidate who is committed to the mission.

Mock up some interview questions based on the job description.

Absolutely. Here are some mock interview questions that could come up:

Tell me about a time when you had to navigate a complex regulatory process in your previous role. How did you approach it?
Describe a situation where you facilitated collaboration between different departments. What challenges did you face, and how did you overcome them?
Can you provide an example of a time you had to influence stakeholders who did not have direct reporting to you? How did you handle the situation?
How do you prioritize competing tasks when facing a tight deadline in a fast-paced environment?
What strategies do you use when coordinating review meetings to ensure all voices are heard and decisions are made efficiently?
How familiar are you with using Veeva for managing regulatory materials? Can you describe how you utilized it in past projects?
Imagine you are faced with a scenario where a promotional material is under scrutiny during the review process. How would you manage the situation to ensure compliance is maintained?
If there is a discrepancy in feedback from teams involved in the regulatory review, how would you resolve it?
Why are you interested in working at Corcept specifically, and how do you see your contributions aligning with our mission?
How do you stay updated with the latest regulatory requirements in the pharmaceutical industry?
What are your methods for measuring the effectiveness of the material review process you oversee?
What aspects of our recent product launches in cortisol modulation excite you the most and why?
What questions do you have about our team dynamics and collaboration when it comes to managing regulatory operations?

Job Details

Overview Company

Associate Director, Commercial Regulatory Operations

$209.7k/y-$246.7k/y

Corcept Therapeutics

3 days ago

Highlight

HybridFull-time8+ yearsDirector

Summary

Corcept Therapeutics is seeking an Associate Director, Commercial Regulatory Operations to join their team in Redwood City, CA. The role involves overseeing the review and approval process for promotional and non-promotional materials, ensuring compliance and efficiency across cross-functional teams.

About the Role

As an Associate Director, Commercial Regulatory Operations, you will manage the end-to-end review process for U.S. and Global promotional and non-promotional materials, coordinate CRT meetings, and track deliverables. You will serve as the primary contact between cross-functional teams, support FDA submission processes, and contribute to process improvement initiatives. This role requires strong organizational skills and familiarity with industry tools like Veeva.

About You

Required:

Experience leading or supporting review committee meetings in a pharmaceutical or life sciences setting.
Familiarity with promotional material review processes and product launch support.
Strong interpersonal and cross-functional collaboration skills.
Ability to manage without direct authority and influence stakeholders effectively.
Excellent analytical, problem-solving, and communication skills.
Proficiency with document and collaboration tools, including Veeva Vault, Box, and SharePoint.

Preferred:

BA/BS Degree in health/life sciences or related field.
8+ years of experience in the pharmaceutical, life sciences or related industry.
Highly organized, detail-oriented, and adaptable.
Ability to thrive in a highly dynamic, fast-paced, continuously changing global environment.
Ability to synthesize data and derive core insights that inform strategy and processes.
Excellent communicator, both oral and written, with strong presentation skills.
Proven experience leading CRT meetings and navigating cross-functional collaboration.
Familiarity with regulatory requirements in the pharmaceutical industry.

Corcept Therapeutics

We’ve been unlocking the potential of cortisol modulation for more than 25 years.

We’re leading the way in the research and development of cortisol modulators, molecules that regulate cortisol activity at the glucocorticoid receptor (GR). To date, we have discovered more than 1,000 selective proprietary cortisol modulators.

In 2012, we received FDA approval of a groundbreaking cortisol receptor blocker and the first approved treatment for hypercortisolism (Cushing’s syndrome).

Today, our team and collaborators continue to unlock the possibilities of cortisol modulation as a way to treat serious diseases. With more than 30 ongoing studies across a wide range of disease areas, including endocrinology, oncology, metabolism, and neurology, we remain dedicated to advancing the possibilities of cortisol modulation.

What began as a ripple of scientific truth is now poised to unleash a sea change of discovery representing a fundamental shift in the way we understand and treat disease.

Redwood City, CA