Sitero is an emerging leader in Clinical services and software solutions for the life sciences industry. We have experience and expertise in a diverse range of therapeutic areas and focus on innovative, technology-enabled solutions that allow our clients to focus on their core strengths. For early phase studies through Phase III clinical trials, our experienced team delivers high-touch services and technology to ensure the safety of all stakeholders across the clinical research community with an emphasis on ethics, compliance, and innovation.
Job Title: Regulatory Consultant
Location: Portugal, Remote
Function: Clinical Services
ESSENTIAL DUTIES AND RESPONSIBILITIES:
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Regulatory Strategy Development
- Develop and implement global and regional regulatory strategies for product development, clinical trials, and market submissions.
- Advise clients or internal teams on regulatory pathways (e.g., FDA, EMA, PMDA) for investigational and marketed products.
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Regulatory Submissions Management
- Prepare, review, and coordinate regulatory submissions such as INDs, NDAs, BLAs, CTAs, MAAs, and amendments.
- Ensure regulatory documents are accurate, complete, and submitted in compliance with applicable regulations.
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Client and Cross-functional Collaboration
- Act as the primary regulatory point of contact for clients or project teams.
- Collaborate with clinical, nonclinical, CMC, and quality assurance teams to align regulatory strategies and submission timelines.
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Regulatory Intelligence and Compliance
- Monitor changes in global regulatory environments and communicate relevant updates to stakeholders.
- Provide regulatory guidance to ensure compliance with local, regional, and international regulatory requirements.
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Health Authority Interactions
- Support or lead the preparation of briefing documents, responses to queries, and meeting requests with health authorities (e.g., FDA Type B/C meetings, EMA scientific advice).
- Attend and facilitate meetings with regulatory agencies as needed.
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Documentation and Quality Review
- Conduct regulatory review of study protocols, investigator brochures, clinical study reports, and labeling materials.
- Ensure high-quality regulatory writing aligned with ICH and agency expectations.
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Project and Timeline Management
- Manage multiple regulatory projects, ensuring deliverables are met on time and within scope.
- Track and report project progress to stakeholders and address risks proactively.
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Training and Mentorship
- Provide regulatory training to internal staff or clients as necessary.
- Mentor junior regulatory staff and contribute to team knowledge sharing.
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Business Development Support (if applicable)
- Assist in the preparation of proposals and presentations for potential clients.
- Participate in client calls and meetings to discuss regulatory services and capabilities.
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Lifecycle Management
- Support post-marketing regulatory activities including labeling updates, annual reports, variations, and renewals.
EDUCATION AND EXPERIENCE REQUIRED:
- Bachelors degree in a science related field is required; MBA or higher education preferred
- 10 years minimum previous experience with a CRO, Biotech, or Pharmaceutical manufacturer
- Proven ability and experience to provide Regulatory Consulting required
- Existing knowledge of Portugal regulatory laws and compliance required
COMPENSATION & BENEFITS:
Sitero proudly offers a competitive hourly compensation rate package for our contracting staff
EMPLOYMENT TYPE:
Contractor, Part Time
COMMITMENTS:
- Part-Time hours as needed
- Willing to work in shifts as and when needed.
DISCLAIMER:
Sitero is an equal opportunity employer and welcomes all job applicants. All qualified applicants will receive consideration for employment without discrimination on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability, or any other factors prohibited by law.
