Bioplus Life Sciences Medical Regulatory Expert
1 day ago
Company Overview
At Bioplus Life Sciences, we are a leading pharmaceutical company with over 75 years of experience in advanced biotechnology. Our mission is to address global unmet medical needs through innovative therapies.
We are currently expanding our research team and inviting talented professionals to join us in shaping the future of healthcare.
About the Role
This exciting opportunity exists for a seasoned Medical Regulatory Expert to lead our medical regulatory writing efforts. As part of our global research team, you will play a pivotal role in ensuring compliance with regulatory requirements from various regions, including FDA, EU, MHRA, and others.
You will be responsible for developing medical expertise within medical regulatory writing, coordinating medical activities related to marketing authorizations, and working closely with management, medical affairs teams, clinical trial teams, and external stakeholders.
Key Responsibilities
- Provide medical assessments with relevant clinical evidence and monitor the execution of strategic documents such as PBRERs, ACOs, DSURs, Clinical Overviews, Benefit-Risk assessments, Expert statements for MDD, Responses to Health Authority Queries, Ad-hoc literature analyses, and labeling documents.
- Draft extended synopses of studies in collaboration with RWE experts and oversee their execution by operational units.
- Write key medical/clinical parts of Common Technical Documents (CTD) or Briefing packages (BP).
- Review and approve compassionate use of individual medical requests for Bioplus medicinal products.
- Secure delivery of high-quality medical documents on time and in compliance with internal and external standards.
- Collaborate effectively with global medical leads, medical product leads, global regulatory affairs, pharmacovigilance teams, managed access program teams, external stakeholders, KOLs, and vendors.
- Contribute to continuous education of the field force.
- Custodian of new treatment guidelines and updates in medicine.
- KOL management and engagement.
Requirements
To be successful in this role, you will need:
- A minimum of 5 years' experience supporting international pharmaceutical companies in medical affairs, clinical development, or pharmacovigilance, with a focus on at least one therapeutic area: metabolism, diabetes, lipid, ophthalmology, pediatric, gynecology, or internal medicine.
- Strong stakeholder management and communication skills.
- Ability to work independently and collaboratively as part of a team.
- Medical degree (M.D.) or equivalent, preferably in Ophthalmology or Pharmacology.
- Excellent English language proficiency (spoken and written).
Why Join Us?
Become part of a dynamic team that makes a significant impact on global healthcare. Enjoy opportunities for professional growth and development in a collaborative, innovative work environment.
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