What will you do?

PROVIDE STRATEGIC REGULATORY GUIDANCE TO MANAGEMENT AND INTER-DISCIPLINARY PROJECT TEAMS

• Provide guidance to inter-disciplinary project teams on regulatory requirements on projects at Phase 1 to 4 of drug development/life cycle.
• Represent independently and proactively regulatory requirements and RA departmental positions to core/projects teams.
• Generate formal written regulatory strategy documents, primarily for combination drug-device products, but also for prescription pharmaceutical products. The strategy document should offer multiple potential solutions but include a recommendation on the best option and why.
• Interact and coordinate with Clinical staff to facilitate clinical studies regulatory compliance and compilation of clinical submission documents.
• Interact and coordinate with R&D staff to ensure compliance with regulatory requirements throughout drug development phases.

PREPARE AND FILE HIGH-QUALITY SUBMISSIONS TO REGULATORY AUTHORITIES

• Compile and file high-quality CTD/eCTD submissions to regulatory authorities (e.g., briefing books, INDs and IND amendments, NDAs and NDA supplements, CTN/CTA, IMPDs, annual progress reports in different formats etc).
• Prepare submission content check list and eCTD Module 1
• Review Module 2 and Module 3 (including technical documents)
• Review Module 4 for completeness per regulatory requirements
• Review Module 5 i.e., clinical study reports and protocols.
• Hold submission kick-off meetings (KOMs) and prepare driver reports for submission deliverables and follow-up with team members, ensuring that all applications are filed in accordance with predetermined timelines.
• Maintain accurate and timely regulatory records and logs.

INTERACT WITH REGULATORY AGENCIES, PRIMARILY US & EU, REGARDING STRATEGY AND RESOLUTION OF COMPLEX ISSUES

• Interact with regulatory agencies (i.e., FDA, EMA) to facilitate the review and approval regulatory submissions and resolution of agency queries.

MANAGE AND PRIORITIZE ASSIGNED PROJECTS IN ACCORDANCE WITH DEPARTMENT AND COMPANY GOALS

• Ensure that multi-disciplinary project teams work effectively and productively and have proper coordination in contributing to regulatory submissions.
• Motivating the project team and assure their focus on departmental or project objectives and deliverables.

STAY ABREAST OF US & INTERNATIONAL REGULATORY INITIATIVES; CONTINUALLY INNOVATE AND ADAPT PRACTICES TO ENSURE BEST PRACTICES

• Stay current on new regulatory or other industry initiatives that could have a significant impact on the company's current or development products.
• Share best practices for planning, organization and time management.
• Gain deep insight into the industry (pharma and/or device) by actively participating in professional organizations.
• Ensure that department management is aware of team activities and progress.
• Project professionalism and a courteous, cheerful and cooperative demeanor.
• Perform other duties as assigned.

How will you get there?

• A Bachelor's Degree in a scientific discipline from an accredited university is required.
• An advanced degree is preferred.
• A minimum of 6 years in pharmaceuticals with 4 years of experience supporting regulatory submissions in drug development.
• Demonstrated experience with health authority submissions in CTD format Modules 1-5 (i.e., INDs, amendments/supplements, NDAs, CTAs, IMPD, MAA, etc.).
• Knowledge of regulatory requirements (FDA/EMA regulations/guidance and ICH guidelines) throughout clinical/drug development and lifecycle management for pharmaceuticals products.
• Experience in representing regulatory affairs on development project teams.
• Thorough understanding of GxPs (i.e., cGMP, GLP, GCP).
• Background in Clinical regulatory affairs: Clinical study reports, protocols, Investigator Brochure, investigator updates, ICF, IRB, site initiation, sponsor/investigator responsibilities etc.
• Knowledge of drug-device combination/device, international regulations/guidance a plus.
• Excellent organizational, project management and writing skills with good understanding of drug development.
• Experience with review and submission of promotional materials a plus.
• Knowledge of post-marketing Pharmacovigilance a plus.
• Regulatory Affairs Certification (RAC) beneficial.