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Position : Regulatory Affairs Specialist

Location : Fort Lee, NJ

DUTIES AND RESPONSIBILITIES:

1. Ensures Regulatory compliance within KEDPLASMA organization to cGMP, Standard Operating Procedures and other applicable Standards and Protocols to meet the regulatory requirements of the FDA, EMEA, Customer Specifications, and other regulatory bodies as required.

2. Reviews operating procedures from a regulatory perspective to ensure procedures as designed, are in compliance with all regulatory standards and requirements (including FDA/EU/PPTA) to ensure proper function, safety and quality.

3. Prepares regulatory filings for FDA and assists with government interactions pertaining to the regulatory process.

4. Researches compliance with regulations when new procedures, policies, changes, and programs are being considered. Prepares analysis of findings and when appropriate uses a wide degree of creativity and latitude to provide strategic guidance for filing in order to achieve the business objective.

5. Performs GAP analyses of new regulatory requirements and customer specifications against current processes/procedures. Submits findings to the appropriate Departments and recommends/initiates the applicable changes to ensure compliance.

6. Prepares and distributes the annual Site Master File (SMF) for each collection center. Compiles information and communicates with Global RA as required to ensure accurate completion of the Product Master File submission.

7. Prepares correspondence and maintains communication files for external customers, suppliers, vendors, etc. including any routine and mandatory reports or updates.

8. Develops and maintains a regulatory reporting calendar of all current filing requirements, i.e. certifications, permits, filings, registrations, licenses, for each individual location, corporate entity, regulatory and governmental agency. Subsequently, tracks renewal/expiration dates for all. Develops a centralized database for all information and ensures the appropriate entities receive the documentation as necessary.

9. Reviews audit reports, provides feedback, along with recommendations for corrective action that can be implemented to assist in addressing audit report findings.

10. Reviews Center deviation reports (Quality Incidents, Post Donation, etc.) to determine biological product deviations (BPD) reporting requirements that may affect the safety, purity, or potency of a distributed product in accordance with 21 CFR, Part 600.14 or 606.171. Provide guidance to Centers to ensure deviation reports provide clear, concise information to capture the event.

11. Prepares and submits BPDRs to FDA. Develops standardized response and formats for the requirements to ensure consistency and accuracy in all submissions. Works with Centers as necessary to ensure that information is thorough and accurate when received by Regulatory. Communicates/advises Centers when discrepant information is submitted so that corrective action is taken for consignee notification. Maintains regulatory files of all BPDR submissions.

12. Assesses need and develops/revises procedures to support the Regulatory department.

13. Participate in software validation, as necessary, by developing, and/or documenting execution of test scripts.

14. Manages assists and/or performs various projects within the operations, regulatory and quality groups as requested. Acts as liaison with designated Project Manager. In instances of performing as Project Manager, acts as liaison with appropriate Department Head.

15. Provide assistance to other departments as needed.

16. Provides support and assistance (on- or off-site) to donor centers during inspections by customers and regulatory agencies.

17. Provide individual training to assist with Regulatory department needs, as well as, assisting Corporate Training department with clarification of regulatory requirements, customer specifications, processes/procedures, as necessary.

JOB SPECIFICATIONS:

1. Bachelor's degree in science required and a minimum of 2 years plasma center experience. 2 years' experience in a regulatory role preferred. Minimum 5 years' work experience demonstrating decision making ability, ability to effectively communicate with and positively influence people, familiarity with fiscal operations, supervisory responsibility, conflict resolution, and customer service.

2. Excellent communication skills and ability to conduct oral and written presentations.

3. Excellent people skills which extends to a diverse group of individuals and demographics.

4. Three to five years of working experience in a biomedical field preferred.

5. Ability to speak read and write in English. Professional appearance and demeanor.

6. Ability to operate computer software including a donor management system (with training), electronic questionnaire, and Microsoft Office.

PHYSICAL REQUIREMENTS :

1. Ability to sit at workstation for extended periods of time.

2. Ability to lift or carry at least 25 lbs.

3. Be able to travel by plane and/or car to various locations including donor centers.

4. Ability to exercise universal precautions for occupational exposure to Blood Borne Pathogens.

5. While performing the duties of this job, the employee is regularly required to stand, stoop and kneel; use hands to handle or feel objects, tools or controls, see, talk and hear.

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status.