TruMinds Clinical
Senior Regulatory Affairs Specialist
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Senior Regulatory Affairs Specialist
Senior Regulatory Affairs Specialist – Remote
About the Company
TruMinds Clinical is a global Functional Service Provider (FSP), clinical staffing, and Contract Research Organisation (CRO) partner. We serve pharmaceutical, biotech, medical device, and healthcare companies—alongside CROs—across the USA and internationally. Our expertise spans customised life sciences services, ensuring tailored processes, reporting, and visibility across all therapeutic areas throughout the full development lifecycle.
We specialise in supporting:
- Clinical trial monitoring
- Clinical trial management
- Drug safety
- Data management
- Statistical programming
Through managed resources, FSP, and project-based outsourcing models, we deliver efficient, cost-effective clinical trials globally (USA, Canada, UK, and India), with eight years of experience executing Phase I–IV trials for organisations of all sizes—including many top pharmaceutical companies.
About the Role
We are seeking a Senior Regulatory Affairs Specialist for a full-time remote position. This role leads global regulatory activities, ensuring seamless support for clinical development and product lifecycle management.
Key Responsibilities
- Prepare, review, and coordinate regulatory submissions to health authorities, ensuring accuracy, compliance, and adherence to guidelines.
- Oversee documentation processes to maintain regulatory files and tracking systems.
- Monitor updates to global regulatory frameworks.
- Collaborate cross-functionally with clinical, quality, pharmacovigilance, and data management teams to interpret regulations and influence strategic decision-making.
- Manage regulatory submission timelines, coordinate responses to queries, and maintain compliance reporting.
- Support study design and development plans with regulatory input.
- Contribute to process improvements and mentor junior team members.
- Represent regulatory strategy to client stakeholders.
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Qualifications
We are looking for a candidate with:
Essential Qualifications
- 6–8 years of experience in Regulatory Affairs, preferably in:
- Pharmaceutical, biotech, CRO, or medical device sectors
- Global clinical trials and lifecycle management
- Strong expertise in regulatory requirements and compliance for major health authorities (FDA, EMA).
- Hands-on experience in preparing and managing regulatory documentation and submissions for clinical trials and product registrations.
- Bachelor’s or Master’s degree in:
- Life sciences
- Pharmacy
- Regulatory affairs
- Or a related field
- ICH-GCP familiarity, along with knowledge of regional regulations and guidelines governing clinical research.
- Attention to detail, analytical problem-solving, and strong documentation skills.
- Excellent organisational skills, with proven project time management and prioritisation.
- Medical device experience (strong preference) to support MDD and MDR requirements, including:
- Understanding of ISO 13485 and EU medical device regulations
- Experience reviewing and approving product labelling
- Intermediate-level proficiency in Microsoft Office Suite (Word, Excel, Outlook) and familiarity with relational database systems (e.g., Agile Project Management tools).
- Ability to work independently or collaboratively in multinational/multicultural teams.
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Desirable Skills
- Advanced knowledge of electronic submission platforms.
- Experience evaluating manufacturing changes for regulatory impact.
- Strong network-building and communication abilities (written and verbal).
- Experience with electronic document management systems.
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