Global Medical Regulatory Strategist

As a Medical Regulatory Specialist, you will play a key role in ensuring the compliance of medical products with regulatory requirements. You will be responsible for developing and maintaining medical expertise within the organization, coordinating activities related to marketing authorizations, and collaborating with stakeholders to ensure seamless communication.

• Develops and maintains medical expertise within the organization on contents, methods, and processes.
• Ensures compliance with regulatory requirements from various regions (FDA, EU, others) for activities supported.
• Coordinates and supports medical activities related to the maintenance of marketing authorizations of Established and Generic products in different therapeutic areas.
• Works in close collaboration with Global Medical Leads, Global Regulatory Affairs, Global Pharmacovigilance, and vendors.

1. Provides a medical assessment with relevant and updated clinical evidence and monitors 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 for the corresponding therapeutic area or products or any other activities which are the core activities of GMLs.
2. Drafts the extended synopsis of studies in collaboration with RWE experts. Oversees the execution of such plans by the respective operational units in compliance with SOP, GCP, and other regulations.
3. Writes Key medical clinical parts of Common Technical Documents (CTD) or Briefing packages (BP).
4. Reviews and approves compassionate use of individual medical requests for use of medicinal products for serious or life-threatening diseases for treatment outside of clinical trials.
5. Secures delivery of high-quality medical documents on time and in compliance with internal and external standards.
6. Collaborates effectively with stakeholders, global medical leads, medical product leads, global regulatory affairs, medical regulatory writing global or local teams, pharmacovigilance teams, managed access program teams.

• Maintains effective relationships with end stakeholders (Medical, regulatory, pharmacovigilance community) within the allocated business unit and product with an end objective to develop medical regulatory content as per requirement.
• Interacts effectively with stakeholders in medical and pharmacovigilance departments.
• Constantly assists the medical regulatory writing team in developing knowledge and sharing expertise.

• Secures deliverables (PBRER, ACO, SO, CSR, ID Cards, Investigator brochure, clinical evaluation report, briefing packages, medical section of CTA, CTD, SBRAs, MDD, HAQs or any other activities which are core activities for GMLs) are supported as per agreed timelines and quality.
• Provides medical strategic insights and evaluation related to the portfolio.
• Contributes to the management of the marketing authorization dossiers of the current related portfolio.
• Acts as an expert in the field of medical regulatory writing and maintains the regulatory requirement for countries and teams supported.
• Assists the assigned medical team in conducting comprehensive medical regulatory writing-needs analysis.
• Implements relevant elements of the medical regulatory plan and associated activities for the year identified for the region.
• Works with selected vendors when required within the region to deliver the required deliverables as per the defined process.
• Assists the head of scientific communications in designing an overall plan of action based on end-customers feedback improving course content and delivery.