Description
The EH Associate, Sr. Associate is responsible for providing operational regulatory support for designated countries, clusters and/or regions.
This role supports submission logistics and technical aspects, ensuring development and delivery of X-regional, regional and/or national regulatory dossiers from initial application and subsequent lifecycle updates, guaranteeing regulatory compliance throughout the submission process.
The individual serves as a trusted partner to global, regional, cluster and local stakeholders, ensuring the timely delivery of high-quality regulatory submissions and operational regulatory support that enables patient access and business objectives.
Responsibilities:
- Planning regulatory submission timelines ensuring regulatory systems are up to date.
- M1 dossier components (authoring, delivery and/or coordination of local, submission-ready documents), excluding labeling and artwork components.
- Simple local only HA query responses authoring.
- Promptly escalate any submission plan delays and develop mitigation strategies aligned with the assessed impact and associated risks.
- The quality review/approval of the Dossier structure for applicable submissions, when required.
- Provide support for general x-functional activities to country Regulatory teams for tenders, out-of-stock reporting, Annual Product Quality Review, risk minimization plans, and coordination of regulatory input for launch planning.
- Identify opportunities to streamline the end-to-end regulatory process, applying digital tools when applicable.
Associate:
- Manages and coordinates lower complexity regulatory activities for assigned products and/or at required dossier execution process workflow as appropriate.
- Accountable for delivering designated tasks with quality and timely as per applicable policy, SOP/Work Instructions, guidelines, or service level agreement.
- Authors, reviews, and maintains local regulatory documents (Module 1 dossier components) for the submission categories / markets or products assigned.
- Coordinates components receipt, translation management, dossier compilation, local ancillary legalization, and submission readiness to facilitate timely Health Authority submissions.
- Ensures the timely delivery of high-quality regulatory submissions and dossier components, monitoring them against milestones to meet business-critical timelines and regulatory requirements.
Senior Associate (cumulative from above):
- Leads and coordinates lower to medium complexity regulatory activities for assigned products and/or at required dossier execution process workflow as appropriate.
- Coordinates with relevant SMEs/functions to address more complex HA queries, based on CRS query response strategy.
- Leads project management activities for regulatory submissions, including development of timelines, work plans, deliverables, risk assessments, and mitigation strategies.
- Monitors' submission progress and proactively identify, escalate, and resolve issues impacting quality, compliance, resource requirements, or regulatory timelines, and support of CAPAs for Quality Events affecting their processes, deliverables, or areas of responsibility.
Qualifications:
- Bachelor’s degree (or equivalent) in Pharmacy, Life Sciences, Business or Information Technology (desirable) required, with at least 2 years for Associate and 3+ years for Senior Associate.
- Fluent English language required. Multilingual skills desirable (including Portuguese in LatAm EH).
- Proven technical aptitude and ability to quickly learn and use new software, regulations and quality standards.
- Advanced Microsoft Office Suite skills.
- Familiarity with pharmaceutical organizational structures, systems, and culture is preferred.
- An understanding of country/cluster regulatory requirements and trends is preferred.
- Relevant experience within pharma, in Regulatory, quality and/or compliance fields preferred.