Senior Manager, Regulatory Affairs

BioSpace; Boca Raton (FL); On-site; USD 140,000 - 180,000; Full time

Benefits offered by this job

401K plan

Medical insurance

Vision insurance

Life insurance

Dental insurance

Pet insurance

STD/LTD

Paid holidays

Tuition assistance

Shuttle service

Job summary

ADMA Biologics, a biopharmaceutical company focused on immunodeficient patients, is seeking a Senior Manager, Regulatory Affairs for onsite work in Boca Raton, FL. The role leads regulatory submissions, provides strategic guidance, and partners with FDA and internal teams to ensure compliance for investigational and marketed products.

Ideal candidate has 10+ years in regulatory affairs, strong Biologics/BLA experience, and hands-on expertise with eCTD and submission systems.

Qualifications

• Bachelor’s degree in Pharmaceutical, Biological or Chemical Science.
• 10+ years in regulatory affairs at management level in pharma.
• Biologics and BLA submission experience.
• Experience with regulatory audits and FDA interactions.

Responsibilities

• Oversee preparation, review, and submission of FDA documents (INDs/BLAs, amendments).
• Provide regulatory guidance to cross‑functional teams and liaise with FDA.
• Develop regulatory strategies and ensure timely submissions and approvals.
• Maintain compliance with FDA regulations and corporate SOPs.
• Support audits/inspections and manage regulatory operations.

Skills

Regulatory affairs

FDA submissions

eCTD knowledge

Regulatory guidance

Project management

Education

Bachelor’s degree in Pharmaceutical/Biological/Chemical science

Tools

Submission software

eCTD knowledge

Job description

Job Description

Senior Manager, Regulatory Affairs in Boca Raton, FL!

Job Title: Senior Manager, Regulatory Affairs

ADMA Biologics is a biopharmaceutical company relentlessly committed to creating superior products for immunodeficient patients at risk for infection. It is our devotion to this underserved population that fuels us and our hands-on approach to production and development that sets us apart. If you are looking for a dynamic, innovative, growing company in the biopharmaceutical industry that is committed to excellence and integrity, then consider ADMA Biologics.

We currently have an exciting opportunity available for a Senior Manager, Regulatory Affairs in Boca Raton, FL! Job Title: Senior Manager, Regulatory Affairs.

Position Summary

This is an onsite, in-person position located in Boca Raton, Florida. The Senior Manager, Regulatory Affairs, supervises and participates in the planning, preparing, and interpreting regulatory documents for submission to the U.S. Food and Drug Administration (FDA). Serves as a liaison with regulatory agencies and affiliates, as well as providing regulatory guidance to address FDA questions for both investigational and market product applications. Ensures corporate policies, procedures and manufacturing/testing activities comply with regulatory requirements and approved INDs/BLAs.

Essential Functions And Responsibilities

• Provides accurate and timely regulatory guidance to Management, Process Development, Analytical Development, Manufacturing, and the Quality Assurance/Quality Control staff while maintaining frequent contact with the Head of Regulatory Affairs.
• Responsible for the preparation, review, presentation, and publishing of all FDA submissions to assure accuracy and completeness of submission documents, which includes but is not limited to meeting requests/briefing packages and presentations to the FDA (e.g., preIND/pre-BLA, end-of-phase II, Type A,B or C, and advisory committee meetings), Investigational New Drug Applications (INDs), Biologic License Applications (BLAs), Orphan Drug Applications, Marketing and Promotional Materials, Product Listing and Establishment License Applications, and other related documents or CMC supplement submissions.
• Develop regulatory strategies, determine submission requirements and requests necessary data, information, and documentation from pertinent departments and Subject Matter Experts (SMEs), as needed. Liaises with clients and Contract Manufacturing Organization (CMO) as appropriate.
• Provides signatory approval for supplements and amendments to INDs/BLAs, assuring submissions are completed within specified regulatory time limits. Reviews and approves all materials to be included in submissions for accuracy and completeness, which include stability, validation and investigation reports, product testing data and information packages prepared by SMEs.
• Act as an authorized official for the organization and correspond with regulatory agencies as necessary to discuss regulatory strategies and request FDA guidance. Participate and provide regulatory support during audits and FDA inspections, as necessary.
• Responsible for providing regulatory guidance regarding investigational and marketed products and provide regulatory support as needed to clients and affiliates.
• Oversee Regulatory Operations by tracking submissions, Post Marketing requirements/commitments, maintenance of investigational and marketing applications and SOPs (standard operating procedures). Appropriate knowledge of eCTD format and submission software systems.

Additional Essential Functions and Responsibilities

• Advises Management of any potential regulatory risks and/or delays in submissions for investigational and marketed products.
• Participates in company projects, project-based tasks and/or special projects as assigned by the Head of Regulatory Affairs.
• Reviews and evaluates Change Controls and Critical Deviations to determine regulatory impact and reporting requirements. Evaluates, prepares, and submits Biological Product Deviation Report, as necessary.
• Advises Project Teams regarding regulatory requirements; serve as Project Team member to ensure primary and alternate strategies are appropriately explored.
• Serves as advisory roles to project teams regarding regulatory requirements and strategy development; keep management and team members abreast of project status and adherence to project deadlines.
• Ensures corporate policies and procedures are in full compliance with regulatory obligations.
• Serves as liaison with the FDA, company personnel, corporate partners, and other regulatory agencies to ensure regulatory activities are completed accordingly within the required timelines.

Education and Experience Requirements

Education Requirements: Bachelor’s degree in Pharmaceutical, Biological or Chemical Science or related field.

Experience Requirements: Ten plus years plus of practical pharmaceutical development regulatory experience at a management level in Regulatory Affairs with an emphasis on Biologics and BLA submission experience.

Compliance Requirements

The minimum compliance expectation for this role entails strict adherence to FDA regulations and company policies governing sales and marketing activities. This includes completion of required compliance training, accurate documentation of sales interactions, and adherence to data privacy regulations. Additionally, the role requires proactive participation in compliance reviews, prompt reporting of any potential issues, and ongoing education to stay updated on relevant FDA regulations.

Job Description Footer

In addition to competitive compensation, we offer a comprehensive benefits package including:

• 401K plan with employer match and immediate vesting
• Medical, Vision, Life and Dental Insurance
• Pet InsuranceCompany paid STD and LTD
• Company Paid Holidays
• 3 Weeks’ Paid Time Off (within the first year)
• Tuition Assistance (after the first year)
• Easily accessible to Tri-Rail
• Free shuttle to the Boca Tri-Rail station

ADMA Biologics uses E-Verify to confirm the employment eligibility of all newly hired employees. To learn more about E-Verify, including your rights and responsibilities, please visit www.dhs.gov/E-Verify.

ADMA Biologics is an Equal Opportunity Employer.