Regulatory Affairs Manager (RA Manager)
Location: Boca Raton, FL
Job Type: Direct Hire
Company: Openwork
Salary: 0
Category: Regulatory Affairs
Job Description Apply Now
The Regulatory Affairs Manager (RA Manager) serves as a pivotal leader in ensuring that all regulatory activities and submissions meet the rigorous requirements of governmental agencies, including the U.S. Food and Drug Administration (FDA). This full-time position is responsible for supervising regulatory documentation, aligning strategies with evolving regulations, and serving as a knowledgeable resource for cross-functional teams. The Regulatory Affairs Manager (RA Manager) plays a key role in maintaining ongoing compliance and fostering collaboration between internal departments and external partners, including regulatory agencies and contractors. Professionals in this role are integral to the success of pharmaceutical and biologics companies, ensuring the timely approval and compliance of new and existing products. Working in this dynamic field offers the opportunity to contribute to the advancement of healthcare while developing expertise in regulatory science and project management.
As a Regulatory Affairs Manager (RA Manager), you will provide expert guidance on regulatory matters, oversee the preparation and submission of various regulatory documents, and ensure organizational policies are aligned with current regulatory requirements. This role involves frequent interaction with senior management, regulatory agencies, consultants, and interdepartmental teams. The Regulatory Affairs Manager (RA Manager) is tasked with staying abreast of evolving laws and regulations, conducting regulatory risk assessments, and ensuring all company procedures are compliant with local and international standards. The ability to manage multiple projects, prioritize deadlines, and mentor team members is essential for success in this position.
Working in this field offers a collaborative and intellectually challenging environment, with frequent opportunities to influence company policy and regulatory strategy. The Regulatory Affairs Manager (RA Manager) will also engage in process improvement initiatives, contribute to the development of standard operating procedures, and represent the company in interactions with regulatory bodies and industry partners. This role is ideal for professionals who thrive in a fast-paced, detail-oriented environment and are committed to advancing public health through regulatory excellence.
Regulatory Affairs Manager (RA Manager) - Summary- Leads regulatory strategy and documentation for submissions to governmental agencies, including the FDA.
- Serves as a primary liaison with regulatory agencies, contractors, and cross-functional teams.
- Ensures corporate policies and procedures comply with current regulatory standards.
- Supervises and mentors regulatory staff to achieve departmental objectives.
- Provide accurate and timely regulatory guidance to all company functions, maintaining close communication with the Associate Director of Regulatory Affairs.
- Prepare, review, and evaluate regulatory submissions, including pre-application, new application, maintenance, and post-marketing documents for FDA and other agencies.
- Develop regulatory strategies that align with business objectives and coordinate the collection of required documentation from internal and external stakeholders.
- Plan regulatory milestones, establish submission timelines, and ensure timely, accurate, and complete submissions to regulatory authorities.
- Oversee regulatory operations by maintaining project timelines, submission tracking systems, and document archives.
- Review, write, and revise policies, SOPs, and work instructions to promote efficient and compliant regulatory processes.
- Collaborate with Quality Assurance to conduct regulatory risk assessments and recommend risk mitigation strategies.
- Oversee biological product deviation reporting and product recall procedures, including notifications and corrections.
- Monitor new laws and regulations, assess their impact on company products, and implement necessary internal changes.
- Serve on project teams to provide regulatory guidance for investigational and marketed products.
- Ensure ongoing compliance with all regulatory requirements and company policies.
- Mentor, manage, and support the professional development of regulatory staff.
- Engage regularly with consultants, FDA representatives, and internal stakeholders to coordinate projects and exchange critical information.
- Analyze complex problems, exercise judgment, and select appropriate evaluation and resolution methods.
- Interact with senior management and executive leadership across multiple functional areas.
- Competitive compensation package commensurate with experience and industry standards.
- Comprehensive health, dental, and vision insurance plans.
- Retirement savings plans and company-matched contributions.
- Paid time off, holidays, and personal days.
- Professional development and continuing education opportunities.
- Employee wellness and assistance programs.
- Bachelor's degree in Pharmaceutical, Biological, Chemical Science, or related field; advanced degree preferred.
- Minimum of 5 years of pharmaceutical regulatory experience across all phases of drug development.
- Experience in biologics and BLA submission is highly desirable.
- Expertise in Good Manufacturing Practices (GMP), Good Clinical Practices (GCP), Good Documentation Practices, and Good Laboratory Practices.
- Strong program management, collaboration, and communication skills.
- Proficiency with standard office software applications.
- Ability to represent the company with professionalism and sensitivity to regulatory issues.
- In-depth knowledge of relevant laws and regulations, including the US Federal Food, Drug and Cosmetic Act, Code of Federal Regulations, and FDA guidelines.
- Familiarity with international harmonization standards and Regulatory Affairs SOPs.
- Demonstrated ability to manage multiple projects and deadlines effectively.
- Willingness to travel as required for business needs.
- Proven leader with a track record in regulatory affairs management within the pharmaceutical or biologics industry.
- Detail-oriented with strong analytical and problem-solving abilities.
- Excellent interpersonal skills and the ability to work effectively in cross-functional teams.
- Adaptable, with experience managing complex projects under tight deadlines.
- Committed to ongoing professional development and regulatory compliance excellence.
- Opportunity to work in a collaborative and supportive environment focused on innovation and regulatory excellence.
- Role offers significant visibility with senior management and opportunities for career advancement.
- If you are passionate about regulatory science and eager to contribute to the advancement of healthcare, we encourage you to apply for the Regulatory Affairs Manager (RA Manager) position by clicking the job application button.
- The company is an equal opportunity employer and values diversity in the workplace. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.