Andor Tech
Website:
andortech.com
Job details:
Shift timings : 06:00 AM - 03.00PM
· Responsible for independently supporting and contributing to regulatory activities required to obtain and maintain product registrations for biological and advanced therapy medicinal products in compliance with international regulatory requirements and company policies. · The role contributes to the successful delivery of global regulatory strategies through hands-on authorship and lifecycle management of high-quality regulatory submissions, proactive identification of regulatory risks and gaps, and effective collaboration with internal and external stakeholders. · The Senior Regulatory Affairs Associate is expected to operate with a high degree of autonomy, exercise sound regulatory judgement, and work productively with BioOra colleagues, partners, customers, and suppliers across multiple regions.
Minimum 5+ years’ experience in Regulatory Affairs within the pharmaceutical or biotechnology industry, with demonstrated experience in biological and/or cell and gene therapy products. · Proven hands-on experience contributing to major regulatory submissions (e.g. BLA, NMA, IND), within CMC, clinical, or non-clinical modules. · Experience supporting responses to regulatory questions and post-approval changes. · Strong working knowledge of FDA, EMA, ICH, and other relevant international regulatory frameworks; experience with TGA and/or Medsafe desirable. · Advanced proficiency in Microsoft Word, with demonstrated experience formatting and managing complex regulatory documents; experience with regulatory publishing or submission management systems (e.g. Lorenz, Accumen or equivalent) is an advantage. · Experience working in global, cross-functional teams, ideally across multiple time zones.
Knowledge &
Attributes · Excellent understanding of ICH guidelines and FDA/EMA guidances, particularly as applied to cell and gene therapies (including CAR T-cell products). · Strong scientific and regulatory writing skills, with the ability to draft clear, regulator-facing documentation independently. · Excellent written and verbal English communication skills, with the ability to convey complex technical concepts clearly and concisely. · Highly organised, detail-oriented, and able to manage multiple deliverables simultaneously. · Demonstrated ability to work independently with minimal supervision in a remote environment. · Confident engaging with SMEs, identifying data gaps, and constructively challenging assumptions where required. · Proactive, solutions-oriented mindset with strong problem-solving skills. · Collaborative team player with a professional and adaptable approach.
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