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FDA- Process Advisor IV

3 months ago

Frederick, United States Diaconia LLC Full time
Diaconia is looking for a talented Process Advisor IV to join our Amazing team

If you're looking to join a company that truly appreciates you and your talents, look no further At Diaconia, we are committed to serving and caring for our colleagues, our clients and our community. Our team is made up of talented individuals who appreciate having the opportunity to contribute their knowledge and experience to further the growth and development of our industry. Our ideal candidates embrace diverse thinking, enjoy partnering with others and are seeking to make a difference

We are currently searching for a new, full-time member for our team for the position of:

Process Advisor IV

We are seeking a highly qualified Process Advisor IV to join our team. The ideal candidate will possess a high level of expertise in regulatory affairs, with a focus on pharmaceutical development and medical product compliance. The Process Advisor IV will be responsible for developing and implementing regulatory strategies, overseeing regulatory filings, and providing critical review of documentation supporting regulatory applications. Additionally, the successful candidate will have a deep understanding of relevant drug, biologics, devices, and combination medical product laws, regulations, and policies.

U.S CITIZENSHIP REQUIRED

Key Responsibilities
  • Develop and implement regulatory strategies for pharmaceutical development projects
  • Oversee regulatory filings for various regulatory pathways (e.g. INDs, NDA, BLAs, PMA, 510(k), EUA)
  • Provide critical review of documentation supporting regulatory applications
  • Maintain a strong understanding of FDA regulations, ICH guidelines, and other relevant regulatory authorities' requirements
  • Stay current on commercial advanced pharmaceutical development and intellectual property management best practices
  • Coordinate with cross-functional teams to ensure compliance with cGxPs (cGLP, cGMP, cGCP) and other quality assurance/compliance standards
  • Apply expertise in Quality Assurance/Compliance and Auditing for medical product development and marketing
  • Provide guidance on clinical study development and implementation, as well as post-marketing activities
  • Support products made available through normal approval processes or emergency use mechanisms
Disclaimer "The responsibilities and duties outlined in this job description are intended to describe the general nature and level of work performed by employees within this role. However, they are not exhaustive and may be subject to change or modification at any time to meet the evolving needs of the organization.

Minimum Qualifications:
  • PhD in Engineering, Science, Systems Management, Business Management, or related discipline with 10 years of general experience and 6 years of relevant experience.
OR
  • Master's degree with 12 years of general experience and 8 years of relevant experience
  • Experience with regulatory strategies and filings for pharmaceutical development.
  • Proficiency in FDA and other relevant regulatory authorities' requirements for medical products
  • Strong knowledge of cGxPs and regulatory affairs related to pharmaceutical development.
  • Expertise in Quality Assurance/Compliance and Auditing for medical product development and marketing
  • Ability to apply expert knowledge to complex technical problems with minimal supervision.
  • Preferred certification in Chemistry, Manufacturing, and Controls


"Preference may be given if you live in a Hubzone Area (go to to check your status) which is a United States Small Business Administration (SBA) program for small companies that operate and employ people in Historically Underutilized Business Zones (Hubzone)."

Applicant selected will be subject to a government security investigation and must meet eligibility requirements for access to classified information. Diaconia is an Equal Opportunity Employer, Minorities/Females/Veterans/Disabled. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, or national origin.

MUST be willing to consent to a background check including a criminal record check, employment, and education verification. No Exceptions

MUST be willing to consent to a background check including a criminal record check, employment, and education verification. No Exceptions