Regulatory Affairs Manager V

Goldbelt, Inc. • $100K — $130K *
Frederick, MD 21702In-Person
Pharmaceuticals & Biotech
11 - 15 years of experience
3 weeks ago
Job Overview by Ladders

Qualifications

  • Bachelor's or Master's degree in Life Sciences, Public Health, Medical, Nursing, Pharmacy, Veterinary, Epidemiology, or related discipline.
  • 15 years of general experience and 10 years of relevant experience in regulatory affairs.
  • Expertise in regulatory strategies and filings (INDs, NDA, BLAs, PMA, 510(k), EUA, etc.).
  • Mastery of relevant laws and regulations regarding drugs, biologics, devices, and combination medical products.
  • Knowledge of FDA Animal Rule regulatory pathway and its application to product development.
  • Experience in clinical study development and marketing regulations with a strong grasp of emergency use mechanisms.
  • Ability to obtain and maintain a Secret security clearance.

Responsibilities

  • Serve as the liaison between regulatory office and product leads for compliance with laws and regulations.
  • Act as a subject matter expert to advocate innovative regulatory strategies for Medical Countermeasures (MCMs).
  • Address critical regulatory challenges by communicating with senior regulatory offices.
  • Conduct training sessions on regulatory requirements and documentation for Department of Defense staff.
  • Review and prepare submissions for regulatory authorities like the FDA, ensuring compliance with eCTD formats.
  • Maintain organized, accurate regulatory documentation in accordance with business rules and electronic systems.
  • Plan and conduct meetings and negotiations with regulatory agencies regarding complex issues.

Benefits

  • Competitive benefits package including medical, dental, and vision insurance.
  • 401(k) plan with company matching and tax-deferred savings options.
  • Paid time off and supplementary benefits offered.
  • Opportunities for professional development and continued education.
Full Job Description
Summary:

The Regulatory Affairs Manager V will work products related to the development and management of regulatory affairs strategic planning and guidance within current and planned vaccine, therapeutic, and/or device/diagnostic advanced development and acquisition contracts.

Responsibilities

Essential Job Functions:

  • Serve as a liaison between the AJPEO MRAS regulatory office and product leads to ensure DoD funded regulatory Sponsors developing MCMs are complying with relevant laws, regulations, and current guidance.
  • Serve as a subject matter expert in regulatory affairs at the working group-level to inform
  • innovative regulatory approaches to develop MCMs against emerging threats.
  • Elevate critical programmatic and project level regulatory challenges to the AJPEO MRAS
  • regulatory office on critical programmatic and project level regulatory challenges.
  • Provide training and advisement to DOD staff on regulations, authoring regulatory documents, and interactions with regulatory authorities
  • Provide input to Sponsors' regulatory documents for submission to FDA or other National
  • Regulatory Authorities (NRAs) and coordinates/prepares and maintains FDA filings (such as INDs, NDA, BLAs, PMA, 510(k), EUA, etc.) in accordance with US FDA or other National
  • Regulatory Authority requirements and with the eCTD submission format, as applicable.
  • Review, draft, manage, maintain and retain regulatory documentation (e.g. TPPs, regulatory strategies, regulatory assessments or whitepapers, study protocols/reports, correspondence with Regulatory Agencies, official briefing packages, submissions, and other relevant regulatory documentation) in accordance with approved business rules in the assigned electronic document management system.
  • Contribute to the modification, development and implementation of internal policies and procedures.
  • Represent the regulatory team, provide regulatory guidance to assigned product teams, and facilitate cross-communication with the interdisciplinary team. In addition, the contractor shall present, orally and in writing, the outcome of these efforts in a timely manner and participate in regulatory audits/inspections as required.
  • Plan, prepare and execute meetings with regulatory agencies on complex and strategic programs; negotiate complex issues with regulatory bodies
  • Provide advice and aid in the implementation of quality systems and procedures to ensure compliance with all applicable laws, regulations, and organizational quality standards in support of advanced development activities.
  • Conducts quality audits and oversight, as assigned for non-clinical and/or clinical and/or manufacturing activities in compliance with relevant laws, regulations and policies.
  • Create and/or review acquisition and contract documents ((e.g., Requests for Proposals (RFPs), Source Selection Evaluation Boards (SSEBs), etc.).) to ensure regulatory and quality requirements are appropriate and consistent with FDA regulations and assess the impact of these requirements to the product development timeline.
  • Collaborate and network with internal/external regulatory professionals and clinicians, as well as investigators and researchers, and other scientific and technical disciplines to maintain current knowledge in the Chemical, Biological, Radiological, and Nuclear (CBRN), Emerging Infectious
  • Disease (EID), and other relevant emerging and re-emerging threat spaces.
  • Travel for presentations and seminars, and to observe and provide regulatory assessments of supplier evaluation visits (e.g., due diligence, mock audits, vendor qualifications, etc.).
  • The contractor shall receive debriefs at the Secret level on Biannual Threat Briefs and be able to assist on course of action development in support of IPT's.

Qualifications

Necessary Skills and Knowledge:

  • Strong communication skills, effectively communicating ideas, requirements, and scientific knowledge; and self-starter.

Minimum Qualifications:

  • Bachelor's or Master's degree in Life Sciences, Public Health, Medical, Nursing, Pharmacy, Veterinary, Epidemiology or a related discipline, as well as fifteen (15) years of general experience and ten (10) years of relevant experience.
  • Experience in developing and implementing regulatory strategies and overseeing regulatory filings (such as INDs, NDA, BLAs, PMA, 510(k), EUA, etc.).
  • Experience with providing critical review of documentation supporting regulatory applications.
  • Possess and maintain a mastery of relevant drug and/or biologics and/or devices, and/or combination medical product laws, regulations and policies (e.g. FDA regulations, ICH guidelines).
  • Experience with medical product development requirements under the FDA Animal Rule regulatory pathway, including animal model development, pharmacokinetics, pharmacodynamics, and toxicity.
  • Mastery of FDA and other relevant regulatory authorities' requirements for clinical study development and implementation and marketing and post-marketing. Contractors shall have experience applying this expert knowledge to products made available through normal approval processes or emergency use mechanisms.
  • Clearance: Secret

Preferred Qualifications:

  • Certification in Regulatory Affairs or other certification relevant to medical product development and/or auditing is desired and will be at no cost to the Government.


Pay and Benefits
At Goldbelt, we value and reward our team's dedication and hard work. We provide a competitive base salary commensurate with your qualifications and experience. As an employee, you'll enjoy a comprehensive benefits package, including medical, dental, and vision insurance, a 401(k) plan with company matching, tax-deferred savings options, supplementary benefits, paid time off, and professional development opportunities.

About Goldbelt, Inc.

Goldbelt, Inc. Careers

Joining Goldbelt, Inc. presents a prime opportunity to be part of a team that values innovation, leadership, and diversity. As a recognized leader in providing innovative solutions, Goldbelt, Inc. offers a variety of job opportunities that cater to professionals seeking growth and development in their careers.

Explore Career Opportunities

Goldbelt, Inc. is actively hiring and offers a range of positions that suit different skills and career aspirations. From internships that provide real-world experience to full-time positions that challenge and expand professional capabilities, Goldbelt, Inc. ensures that every team member can find a path that suits their career goals.

Professional Growth and Development

Goldbelt, Inc. is committed to the professional growth of its employees. With comprehensive training programs and leadership development opportunities, employees are equipped to take on leadership roles within the company. The emphasis on continuous learning and development ensures that every employee has the tools needed to succeed and innovate within their field.

Diversity and Inclusion

At Goldbelt, Inc., diversity is more than just a buzzword. The company fosters an inclusive culture where diverse perspectives are valued and contribute to the company's success. Diversity training programs are integral, ensuring that all team members understand and appreciate the strength that lies in differences.

Benefits and Culture

The benefits at Goldbelt, Inc. go beyond standard employment perks. Employees enjoy a supportive culture that promotes work-life balance, alongside benefits that cater to both personal and professional needs. This supportive environment ensures that employees feel valued and motivated to contribute their best work.

Networking and Career Advancement

Goldbelt, Inc. encourages networking within the industry, providing employees with numerous opportunities to connect with peers and leaders who can influence their career trajectory. These connections are vital for professional development and can lead to new opportunities within the company.

Applying for a Position

To apply for a position at Goldbelt, Inc., candidates are encouraged to submit a resume that highlights relevant experience and skills. The interview process is designed to assess not only professional qualifications but also a candidate's fit within the company culture and their potential to contribute to the team’s success.

Stay Connected with Goldbelt, Inc. Careers

Interested candidates can stay updated on new job opportunities and company news by subscribing to job alert emails. This personalized subscription keeps potential applicants informed about positions that match their skills and career interests.

Join Goldbelt, Inc.

Explore the career opportunities at Goldbelt, Inc. and discover how joining this team can enhance professional skills, foster personal growth, and provide a rewarding career path in a dynamic and supportive environment.

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Learn more about Goldbelt, Inc.
Industry
Aerospace & Defense
* Ladders Estimates

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