Apsida Life Science | Regulatory Affairs Manager
3 weeks ago
Regulatory Submission Manager (Immediate start)
Collaborate with Global Regulatory Team Leads, and submission teams to ensure timely, high-quality regulatory submissions that comply with global guidelines and company SOPs. Provide mentorship and training to team members, fostering excellence and first-time-right submissions.
Responsibilities/Experience
- Deliver marketing, investigational, and lifecycle maintenance submissions in compliance with regulatory timelines and standards.
- In-depth knowledge of the pharmaceutical industry, regulatory affairs, and drug development (pre-IND through Phases I-IV).
- Proven ability to interpret regulations and align on complex strategies.
- Lead submission teams for renewals, label harmonization, PBRERs, and other regulatory activities.
- Experience managing projects and working within matrix environments.
- Develop delivery strategies and accelerate timelines through scenario planning for multiple regulatory approaches.
- Liaise with regulatory agencies to address queries and resolve submission-related issues.
- Act as the POC, maintaining workplans and tracking milestones aligned with product development phases.
- Support teams with expert advice on submission processes and market-specific requirements, while mentoring and coaching team members.
- Process Optimization: Lead or contribute to initiatives aimed at improving workflows and ensuring regulatory compliance.
- Identify and address risks, escalating issues when needed to ensure seamless progress and transparency.
- Lead multidisciplinary discussions on submission strategies, timelines, and resource management.
Immediate start
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