California Institute of Genetics
Website:
calgenetics.org
Job details:
Job Title: Lead – Regulatory, Clinical & Bioprocess Training Programs
Company: ANCONS
Location: Remote (India)
Type: Full-Time
About the RoleANCONS is hiring a Lead – Regulatory, Clinical & Bioprocess Training Programs to design and build industry-aligned certification programs targeting global life sciences careers, with a strong focus on EU regulatory and pharma industry standards.
This is a high-impact, foundational role responsible for creating structured, job-oriented training programs across Regulatory Affairs, Clinical Operations, and Biopharmaceutical Manufacturing.
Key Responsibilities- Lead the design and development of 3 certification programs:
- Regulatory Affairs & Quality (RA/QA)
- Clinical Operations & Pharmacovigilance (ClinOps/PV)
- Bioprocessing & Validation (CSV/CQV)
- Develop:
- Curriculum frameworks and module structures
- Learning outcomes and competency mapping
- Case studies, assignments, and capstone projects
- Ensure alignment with global regulatory and industry standards:
- EU regulatory frameworks (EMA)
- US FDA regulations (21 CFR)
- ICH guidelines (Q9, Q10, E6 GCP)
- Create high-quality training content:
- Presentations and learning materials
- SOP-style documentation
- Real-world industry scenarios
- Coordinate with external Subject Matter Experts (SMEs) for specialized modules
- Design programs to prepare candidates for roles such as:
- Regulatory Affairs Associate / QA Specialist
- Clinical Research Associate / Drug Safety Officer
- Validation Engineer / Bioprocessing Associate
Required Qualifications- Bachelor’s or Master’s degree in:
- Life Sciences / Pharmacy / Biotechnology / Biomedical Sciences
- 5–10 years of industry experience in ONE of the following domains:
- Regulatory Affairs / Quality Assurance (preferred)
- Clinical Research / Pharmacovigilance
- Biopharmaceutical Manufacturing / Validation
- Strong understanding of:
- GMP principles
- ICH guidelines
- Clinical trials or validation frameworks
- Prior experience in:
- Training, teaching, or curriculum development
- Regulatory documentation, audits, or SOPs
Preferred Qualifications- Exposure to EU regulatory environment
- Experience with CROs, pharma, or biotech companies
- Background in EdTech, training programs, or workforce development
What We’re Looking For- Ability to translate industry knowledge into practical, job-ready training
- Strong ownership mindset with ability to build programs from scratch
- Structured thinking and attention to detail
CompensationCompetitive, based on experience
Click on Apply to know more.