Senior Associate, Regulatory Affairs

📋 Description

• Serve as the data steward for regulatory information within the RIM system, ensuring data accuracy, completeness, and timeliness through entry, updates, and maintenance.

• Create, archive, and manage regulatory submissions, Health Authority correspondence, and commitments in the RIM system, adhering to internal standards.

• Maintain submission trackers and timelines, and monitor submission history and Health Authority commitments to ensure milestone visibility.

• Collaborate with cross-functional teams and Regulatory Operations to facilitate US submission planning, compilation, and the prompt delivery of regulatory documentation.

• Assist in the preparation and organization of regulatory submission components, including INDs, CTAs, and amendments.

• Conduct quality control activities, including eCTD QC for US submissions where applicable, to guarantee completeness, consistency, and technical readiness.

• Support inspection readiness efforts, such as TMF health checks and document completeness reviews.

• Facilitate department meetings and cross-functional communications by developing agendas, coordinating materials, and documenting outcomes.

⛳️ Requirements

• Bachelor’s degree (or equivalent) in a relevant scientific field.

• Over 2 years of experience in the pharmaceutical or biotechnology sectors, preferably in regulatory affairs.

• Strong organizational abilities, meticulous attention to detail, and the capability to juggle multiple tasks simultaneously.

• Excellent written and verbal communication skills to effectively convey operational considerations and collaborate with both internal and external stakeholders.

• Demonstrated proficiency in MS Word, Excel, and PowerPoint; familiarity with SharePoint/Teams is preferred.

• Experience with the Veeva Regulatory Information Management (RIM) platform and eCTD submissions is preferred.

• Consistently demonstrate Apogee’s C.O.R.E. values: Caring, Original, Resilient, and Egoless.

• This position may require up to 10% travel, including mandatory in-person attendance at All Hands meetings typically held twice a year.

🏝️ Benefits

• A vibrant culture, rooted in our C.O.R.E. values: Caring, Original, Resilient, and Egoless.

• Opportunity to thrive in a fast-paced, dynamic environment where you can influence the culture and the company, take on various roles, and learn rapidly.

• Competitive market compensation and benefits package, which includes a base salary, performance bonuses, equity grant opportunities, and health and retirement benefits.

• Generous time off policies, featuring three weeks of PTO, two company-wide shutdowns each year, and dedicated paid sick leave.

• A commitment to your professional growth, with access to resources to advance your development.

• Apogee organizes regular all-team, in-person meetings to foster relationships and encourage problem-solving.