Regulatory Officer, CMC

at  ProPharma Group

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 world’s 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 R&D 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.

We celebrate our differences and strive to create a workplace where each person can be their authentic self. We are committed to diversity, equity, and inclusion. Employees are encouraged to unleash their innovative, collaborative, and entrepreneurial spirits. With a holistic approach as an Equal Opportunity Employer, we provide a safe space where all employees feel empowered to succeed.
*ProPharma Group does not accept unsolicited resumes from recruiters/third parties. Please, no phone calls or emails to anyone regarding this posting.

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
• Trainin

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