Regulatory Affairs Manager
Location: Boca Raton, FL
Job Type: Direct Hire
Company: Openwork
Salary: 0
Category: Regulatory Affairs
Job Description Apply Now
Regulatory Affairs Manager
The Regulatory Affairs Manager plays a pivotal role in ensuring regulatory compliance and facilitating successful submissions to the U.S. Food and Drug Administration (FDA) for investigational and marketed pharmaceutical products. This position is responsible for managing the planning, preparation, review, and interpretation of regulatory documents, and for acting as a primary liaison between the organization, regulatory agencies, and affiliated partners. The Regulatory Affairs Manager also provides expert regulatory guidance and support across multiple departments, ensuring that all regulatory requirements are met and that both corporate policies and procedures are fully compliant with current regulations and approved Investigational New Drug Applications (INDs) and Biologics License Applications (BLAs).
By actively engaging with regulatory agencies, the Regulatory Affairs Manager helps the organization navigate the complexities of compliance, regulatory changes, and submission strategies for pharmaceutical development. The role includes oversight of regulatory operations, participation in audits and inspections, and the development of regulatory strategies that expedite product development and approval. Additionally, the Regulatory Affairs Manager ensures the timely and accurate preparation of FDA submissions, including correspondence, briefing packages for advisory meetings, and supplemental applications.
This full-time position is well-suited for professionals with extensive experience in regulatory affairs, particularly those with a strong background in biologics, BLA submissions, and federal pharmaceutical regulations. The Regulatory Affairs Manager collaborates closely with management, quality assurance, manufacturing, process development, and analytical development teams, maintaining communication with the Head of Regulatory Affairs to provide accurate and timely updates on submission statuses, potential risks, and regulatory developments.
Joining this growing organization offers an excellent opportunity to contribute to the development and approval of innovative pharmaceutical products, while enhancing your career in regulatory affairs. The positive work environment and the chance to work with a dedicated, cross-functional team make this an ideal position for driven professionals seeking new challenges in the regulatory field. If you are passionate about regulatory compliance and want to make a meaningful impact, we encourage you to apply by clicking the job application button.
Regulatory Affairs Manager - Summary- Key regulatory leader responsible for FDA submissions and compliance.
- Serves as a liaison between the company, regulatory agencies, and affiliates.
- Ensures regulatory strategies are effectively implemented for investigational and marketed products.
- Provides expert regulatory guidance to cross-functional teams.
- Provide timely and accurate regulatory guidance to management, development, manufacturing, and quality teams.
- Prepare, review, present, and publish FDA submissions, including INDs, BLAs, Orphan Drug Applications, and supplemental documents.
- Develop regulatory strategies and determine submission requirements in collaboration with subject matter experts.
- Serve as an authorized official for regulatory correspondence with agencies.
- Support audits, FDA inspections, and regulatory reviews.
- Track regulatory submissions, manage post-marketing requirements, and maintain application records.
- Advise management on regulatory risks, potential delays, and compliance matters.
- Participate in cross-functional projects and serve as a regulatory advisor to project teams.
- Review and evaluate change controls, deviations, and impact on regulatory reporting.
- Ensure corporate policies and SOPs are compliant with regulatory obligations.
- Maintain open communication with the Head of Regulatory Affairs and other organizational leaders.
- Competitive base salary, commensurate with experience and qualifications.
- Comprehensive benefits package offered to full-time employees.
- Opportunities for professional growth and advancement within the organization.
- Bachelor's degree in Pharmaceutical, Biological, Chemical Science, or a related field (Master's degree preferred).
- 10+ years of regulatory experience in pharmaceutical development, with management-level responsibilities.
- Extensive experience with biologics, BLA submissions, and federal pharmaceutical regulations.
- Strong written and verbal communication skills.
- Proficient in document management and word processing software.
- Thorough understanding of the Federal Food, Drug, and Cosmetic Act, Code of Federal Regulations, and FDA guidelines.
- Demonstrated ability to analyze complex problems and exercise sound judgment based on regulatory requirements.
- Ability to manage multiple projects and adapt to changing priorities.
- Commitment to ongoing compliance training and adherence to data privacy regulations.
- Seasoned regulatory affairs professional with a proven track record in pharmaceutical development and FDA submissions.
- Demonstrates leadership and cross-functional collaboration skills.
- Excels in a dynamic, fast-paced environment and adapts quickly to change.
- Detail-oriented, organized, and proactive in managing compliance and regulatory requirements.
- Strong communicator with the ability to represent the company to external agencies with professionalism.
- This position requires strict adherence to FDA regulations and company policies for sales and marketing activities.
- Regular participation in compliance reviews and proactive reporting of potential issues is expected.
- Ongoing education to stay current with regulatory changes and requirements is encouraged.
- The organization is committed to providing a supportive, inclusive, and growth-oriented work environment.
- Interested candidates are encouraged to apply promptly by clicking the job application button for consideration.