RA Associate II PharmaApply Now Current Employee? Job ID 17000R3H
PURPOSE AND SCOPE:
Assists in ensuring that all company pharmaceutical products meet regulatory requirements by supporting all assigned regulatory aspects of product approval and post-marketing compliance. Under general supervision, coordinates, prepares/authors, and reviews submissions for FDA, primarily Chemistry, Manufacturing, and Control (CMC). Assists in collecting and preparing documentation packages for US drug submissions, periodic updates, and compliance submissions to regulatory agencies for FMCNA pharmaceutical products. Assists in organizing regulatory information and tracking submissions.
- AuthorsPRINCIPAL DUTIES AND RESPONSIBILITIES: , coordinates, collects and prepares documentation packages for US drug submissions, periodic updates, and compliance submissions to regulatory agencies. Organizes regulatory information resources and tracks and controls submissions. Reviews and advises on labels, labeling, protocols, and (CMC) changes for compliance with regulatory filings.
Under general supervision, collects and coordinates information to prepare regulatory documentation packages for review and submission to regulatory agencies ensuring compliance with all applicable policies, procedures and regulatory requirements and guidelines.
- Authors eCTD sections (primarily CMC) for FDA submissions necessary for drug approval, including New Drug Applications (NDAs), Abbreviated New Drug Applications (ANDAs), Investigational New Drug Applications (INDs), and related amendments and supplements.
- Coordinates and reviews the documentation received from cross-functional team members for accuracy, completeness and to ensure compliance with applicable regulations and requirements. Identifying issues and addressing them with team members and/or management for resolution prior to submission.
- Compiles materials for periodic submission updates for Annual Reports and assembles/coordinates submission of Periodic Adverse Event Reports (PADERs); analyzes and reviews for accuracy and compliance for approved products. Submits annual drug registrations,
- Monitors submissions to ensure adherence to established/proposed timelines, investigates and addresses identified discrepancies.
- Acts as a liaison with the relevant groups and organizations. Researches information for responding to various questions or requests for information from groups including the FDA and other FMCNA departments. Prepares all the necessary forms and completes the response documentation according to the required specifications.
- Researches, develops and recommends submission strategies.
- Monitors and maintains regulatory files/database and chronologies in good order. With other team members maintains system for tracking changes in documents submitted to agencies. Contributes to development of systems, as needed, to improve tracking and documentation needs.
- Maintains current knowledge of drug regulations, guidance, and standards applicable drug product submissions. Analyzes the information regarding changes and updates, advises and makes recommendations as needed to management and potentially impacted personnel/departments.
- Assists with compliance activities and regulatory research of competitor products as necessary.
- Participates in departmental continuous improvement activities. Makes recommendations for process improvements to improve efficiency and accuracy of drug submissions and other procedures.
- May provide assistance to junior level staff with general tasks that require a better understanding of functions, as directed by immediate supervisor.
- May refer to senior level staff for assistance with higher level problems that may arise.
- Escalates issues to supervisor/manager for resolution, as deemed necessary.
- Review and comply with the Code of Business Conduct and all applicable company policies and procedures, local, state and federal laws and regulations.
- Other duties as assigned.
Additional responsibilities may include focus on one or more departments or locations. See applicable addendum for department or location specific functions.
PHYSICAL DEMANDS AND WORKING CONDITIONS:
- The physical demands and work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
- Reviewing of archival paper submissions to FDA may involve lifting multiple volumes each weighing up to 5 lbs.
- 10 – 15% domestic and international travel required.
Bachelor’s Degree required
EXPERIENCE AND REQUIRED SKILLS:
- 2 – 5 years’ related experience; or an advanced degree without experience; or equivalent directly related work experience.
- Demonstrated working knowledge of scientific principles and domestic regulatory requirements.
- A self-starter, with the ability to work independently, and as part of a team.
- Experience working in CMC and post-approval changes desired.
- Very detail oriented, well organized, and driven to meet deadlines and program goals.
- Strong verbal and written communication skills including the ability to make effective and persuasive presentations.
- Strong computer skills with working proficiency of Microsoft Office. Microsoft project and experience with word templates a plus.
- Prior experience with eCTD submissions preferred. Basic knowledge of CTD required.
EO/AA Employer: Minorities/Females/Veterans/Disability/Sexual Orientation/Gender Identity