Regulatory Officer, CMC

For the past 20 years, ProPharma has improved the health and wellness of patients by providing advice and expertise that empowers biotech, med device, and pharmaceutical organizations of all sizes to confidently advance scientific breakthroughs and introduce new therapies. As the worlds largest RCO (Research Consulting Organization), ProPharma partners with its clients through an advise-build-operate model across the complete product lifecycle.With deep domain expertise in regulatory sciences, clinical research solutions, quality compliance, pharmacovigilance, medical information, and RD technology, ProPharma offers an end-to-end suite of fully customizable consulting solutions that de-risk and accelerate our partners most high-profile drug and device programs.

The Regulatory Sciences Officer, Lifecycle Management has responsibilities and inputs into the following core areas:

Client Experience

Regulatory Affairs Activities (strategic operational)

Contracts and Time Management

Finance Invoicing

Quality Team performance metrics

Training

Responsibilities:

• Regulatory CMC writing of pharmaceutical quality documentation (CTD-Modules 2.3 3, IMPD, ASMF).
• Ensure all regulatory documents are accurate and comply with relevant regulations.
• Act as a client liaison and represent ProPharma in a professional and effective manner.
• Coordinate and manage multiple projects simultaneously while ensuring deadlines are met.
• Collaborate with cross-functional teams and stakeholders to ensure project success.
  
  
  

Requirements:

• 1-2 years of regulatory CMC experience working in the biotech or pharmaceutical industry.
• Experience working across different projects concurrently.
• Understanding of the pharmaceutical product life cycle.
• Experience in preparing documentation for regulatory authorities.
• Organised, proactive and self-motivated individual with a keen eye for detail, ability to prioritise tasks effectively and ability to delegate to team members.
  
  
  

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