Senior Regulatory Affairs Associate
New
J
JobgetherLife Sciences
Based in IndiaFull-TimeSenior
Salary not disclosed
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Job Details
- Experience
- 5+ years
- Required Skills
- Project ManagementStakeholder managementRisk Management
Requirements
- Bachelor’s degree in Life Sciences, Pharmacy, or a related discipline.
- 5+ years of relevant industry experience within pharmaceutical, clinical research, CRO, or a comparable life sciences environment.
- Demonstrated experience managing Clinical Trial Application submissions across EU CTR and Rest of World regions.
- Strong project management experience, ideally within global, matrixed, or multinational organizations.
- Solid understanding of clinical trial processes and regulatory requirements.
- Practical knowledge of regulatory submission planning, execution, documentation, and compliance.
- Strong risk and issue management skills, with the ability to anticipate challenges and implement effective solutions.
- Excellent stakeholder engagement and communication skills, with the ability to work effectively across functions and geographies.
- Strong analytical, organizational, problem-solving, and decision-making abilities.
- Adaptability and resilience when managing changing priorities, complex projects, and tight regulatory timelines.
- Collaborative mindset with the ability to work independently while contributing effectively within global teams.
Responsibilities
- Lead end-to-end Clinical Trial Application project management across multiple studies, countries, and regulatory environments.
- Plan, coordinate, track, and deliver clinical trial submissions in accordance with regulatory requirements and agreed timelines.
- Apply strong knowledge of EU Clinical Trials Regulation (EU CTR) and relevant Rest of World CTA requirements to support compliant submissions.
- Manage submission documentation, dependencies, risks, issues, and complexities across global regulatory projects.
- Coordinate effectively with cross-functional and geographically distributed teams to ensure submission deliverables are complete, accurate, and delivered on schedule.
- Build and maintain productive relationships with internal and external stakeholders, facilitating alignment and resolving conflicts when required.
- Monitor key performance indicators related to submission timelines, deliverable quality, and project execution.
- Identify potential risks proactively and lead or support quality investigations and corrective actions where necessary.
- Maintain clear project tracking and communication throughout the submission lifecycle.
- Contribute to continuous improvements in regulatory submission processes, tools, and ways of working.
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