Regulatory Affairs Director Job Listing at Kelly Services in Ballwin, MO (Job ID 9640960)

Description

Kelly Scientific is leading the search for a Regulatory Affairs Director – a permanent role with a pharmaceutical company focused on discovery and development of novel therapeutics to address unmet medical needs. This position will lead all regulatory activities, especially CMC aspects of new API and pharmaceutical product development.

Title: Regulatory Affairs Director
Location: Ballwin, MO
Salary: $145-160,000 + Benefits (Health/Dental/Vision insurance, performance-based bonus, etc.)

Key Responsibilities:

• Regulatory Strategy Development: Develop and implement regulatory strategies to support the development, approval, and lifecycle management of NDA and Innovation products, ensuring alignment with global regulatory requirements.
• Regulatory Submissions: Lead the preparation, review, and submission of regulatory application, including INDs, NDAs, BLAs, ANDAs, MAAs, and other global regulatory filings.
• Compliance: Ensure compliance with all relevant regulatory guidelines and standards, including ICH guidelines, FDA regulations, EMA requirements, and other global health authority expectations.
• Cross-Functional Collaboration: Work closely with R&D, manufacturing, quality, and other cross-functional teams to ensure that all CMC-related activities are aligned with regulatory requirements and timelines.
• Health Authority Interactions: Serve as the primary point of contact for regulatory interactions with global health authorities, including responding to inquiries, addressing deficiencies, and negotiating with regulatory bodies.
• Documentation and Reporting: Oversee the preparation and maintenance of high-quality regulatory documents, including CMC dossiers, technical reports, and responses to regulatory queries.
• Risk Management: Identify potential regulatory risks associated with CMC activities and develop strategies to mitigate these risks.
• Regulatory Intelligence: Stay abreast of changes in global CMC regulatory requirements and ensure that the company's regulatory strategies are up to date and compliant with the latest guidelines.
• Team Leadership: Lead and develop a team of CMC regulatory professionals, providing guidance, mentoring, and performance management to ensure a high level of expertise and efficiency within the team.
• Training and Development: Provide training and support to internal teams on CMC regulatory requirements and best practices to ensure that all stakeholders are informed and compliant.

Qualifications:

• Education:  PhD in Pharmaceutical Sciences, Chemistry, Chemical Engineering, or a related field. Regulatory Affairs Certification (RAC) is a plus.
• Experience: Minimum of 15 years of experience in the pharmaceutical industry, with at least 5 years in a CMC regulatory role. Experience with both small molecules and biologics is preferred.
• Regulatory Expertise: Deep knowledge of global CMC regulatory requirements, including experience with INDs, NDAs, ANDAs, and other regulatory submissions.
• Technical Knowledge: Strong understanding of pharmaceutical development, manufacturing processes, analytical methods, and GMP compliance.
• Project Management: Proven ability to manage complex projects and timelines, with experience leading cross-functional teams to meet regulatory submission deadlines.
• Communication Skills: Excellent written and verbal communication skills, with the ability to effectively communicate complex regulatory information to diverse audiences.
• Problem-Solving: Strong analytical and problem-solving abilities, with a proactive approach to identifying and addressing regulatory challenges.
• Leadership: Demonstrated leadership experience, with a track record of building and leading high-performing regulatory teams.

Qualifications (Preferred):

• Experience in global regulatory submissions and interactions with health authorities, including the FDA, EMA, and other regulatory bodies.
• Experience with lifecycle management of pharmaceutical products, including post-approval changes and compliance.
• Familiarity with regulatory software and tools used in the preparation and submission of regulatory documents.
• Fluent in both English and Mandarin.

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.

 Apply on company website