Offer summary

Qualifications:

Bachelor's Degree in a life science field, 3+ years of clinical regulatory experience, Strong understanding of regulatory compliance and guidelines, Excellent organizational and communication skills.

Key responsabilities:

Prepare and submit regulatory documents for INDs, NDAs, and MAAs to health authorities

Ensure compliance with regulations and guidelines from various regulatory agencies

Maintain accurate and organized regulatory documentation and records

Provide guidance to research teams on regulatory matters and participate in audits.

Job description

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. 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 Clinical Regulatory Specialist ensures compliance with regulations and standards for clinical trials and research, managing regulatory submissions, maintaining documentation, and providing regulatory guidance to research teams.

Responsibilities

Prepare and submit regulatory documents for INDs, NDAs, MAAs to health authorities.
Ensure compliance with regulations and guidelines, as well as those of other regulatory agencies.
Maintain accurate and organized regulatory documentation, records, and databases.
Provide guidance and support to research teams on regulatory matters, including protocol development, informed consent forms, and other study documents.
Manage and maintain regulatory information
Participate in internal and third-party audits

Requirements

Bachelor's Degree in a life science field.
3+ years of clinical regulatory experience

*6 month contract opportunity; full-time hours, remote working

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.***

Required profile