The Associate, Regulatory Affairs Operations is responsible for the preparation and publishing of electronic regulatory documents and submissions and for ensuring these deliverables are compliant with health authority guidelines. This position is also responsible for the archiving of regulatory correspondence, the preparation and submission of Periodic Adverse Events Reports (PADERS), PADER Waivers, and maintenance of databases within the Regulatory Affairs department. Additionally, and as assigned, the incumbent will perform the essential duties and responsibilities related to pre- and post-approval submissions.
All incumbents are responsible for following applicable Division & Company policies and procedures.
Scope of Authority - span of control (work unit, site, department, division, etc.), monetary value of budget/spend authority ( capital, operating, etc.), P&L responsibility, etc.
U.S. generic and branded product portfolios
Key Accountabilities - key outcomes/deliverables, the major responsibilities, and % of time
% of Time
§ Prepare regulatory submissions to various health authorities in compliance with appropriate company business processes and external regulations/guidance/specifications.
§ Submit eCTD submissions to health authorities and track related information in department databases.
§ Publish (e.g. convert to PDF, bookmark, hyperlink) individual regulatory documents as needed.
§ Remain current on internal/external electronic submission initiatives and requirements.
§ Prepare and submit Periodic Adverse Drug Experience Reports in accordance with current FDA requirements.
§ Identify and implement enhancements in business processes with other departments to ensure all eCTD submissions meet health authority requirements.
§ Routinely assess the department’s electronic submission capabilities and processes and provide feedback to Regulatory management in order to improve efficiency.
Communication & Collaboration
§ Coordinate with Drug Safety on the preparation and submission of Periodic Adverse Event Reports (PADERS) and PADER Waivers, as applicable.
§ Interact with Regulatory colleagues at remote sites to assist with workloads and/or to troubleshoot Operations-related issues.
§ Interface with external partners to obtain submission-compliant bioequivalence/clinical study documentation (Module 2 and Module 5).
§ Collaborate with external partners to communicate PDF publishing requirements and to remediate issues, if applicable.
§ Maintain Regulatory Affairs databases with current product information (applications, submissions, Deficiency letters, etc.) and run reports (i.e. quarterly reports).
§ Archive and maintain regulatory documentation (paper or electronic) in accordance with applicable regulatory requirements and the Company’s established practices and procedures.
§ Assist in the development of training materials for internal personnel on regulatory operations topics.
§ Train colleagues on eCTD requirements and related software.
§ Train colleagues on business processes involving Module 5 document processing for BE studies.
Regulatory & FDA Guidance
§ Review FDA Regulatory Guidance related to electronic submission format and compliance to ensure ongoing compliance with eCTD requirements.
§ Provide regulatory support for pre- and post-approval submission and address all electronic and software related issues.
§ Act as regulatory liaison with all departments within the company.
Education & Experience
Minimal acceptable level of education, work experience and certifications required for the job
§ Bachelor’s degree in a scientific or other related discipline or an equivalent overall level of knowledge based upon previous work experience.
§ 1-3 years’ experience in regulatory affairs, preferably with a focus on electronic submissions.
Proficiency in a body of information required for the job
e.g. knowledge of FDA regulations, GMP/GLP/GCP, Lean Manufacturing, Six-Sigma, etc.
§ Adobe Acrobat and MS Office proficiency required.
§ Knowledge of the pharmaceutical business and regulations and drug development process is helpful.
Often referred to as “competencies”, leadership attributes, skills, abilities or behaviors that may be enterprise, functional or job specific e.g. coaching, negotiation, calibration, technical writing etc.
§ Quality - Demonstrates accuracy and thoroughness; looks for ways to improve and promote quality; applies feedback to improve performance; monitors own work to ensure quality.
§ Quantity - Meets productivity standards; completes work in timely manner; strives to increase productivity; works quickly.
§ Adaptability - Adapts to changes in the work environment; manages competing demands; changes approach or method to best fit the situation; able to deal with frequent change, delays, or unexpected events.
§ Initiative - Volunteers readily; undertakes self-development activities; seeks increased responsibilities; takes independent actions and calculated risks; looks for and takes advantage of opportunities; asks for and offers help when needed.
§ Written Communication - Writes clearly and informatively; edits work for spelling and grammar; varies writing style to meet needs; presents numerical data effectively; able to read and interpret written information.
§ Oral Communication - Speaks clearly and persuasively in positive or negative situations; listens and gets clarification; responds well to questions; demonstrates group presentation skills; participates in meetings.
§ Dependability - Follows instructions, responds to management direction; takes responsibility for own actions; keeps commitments; commits to long hours of work when necessary to reach goals; completes tasks on time or notifies appropriate person with an alternate plan.
Physical & mental requirements e.g. lift 40 pounds, walk across plant/warehouse, business travel (% of time), driving as part of work responsibilities, etc.
§ Office environment.
§ Limited overnight travel may be required.
Disclaimer: The above statements are intended to describe the general nature and level of work performed by employees assigned to this job. They are not intended to be an exhaustive list of all duties, responsibilities, and qualifications. Management reserves the right to change or modify such duties as required.