Competitive- Above Market Average
7 days ago
In this vital role you will support one or more products from a regional regulatory perspective. As a member of the Global Regulatory Team (GRT), the Manager will achieve the desired labeling by developing and executing regional regulatory strategies and leading agency interactions.
- Ensure that Biotech acquires and maintains all the licenses in order to support clinical trials for investigational medicinal products as well as market commercially approved medicinal products.
- Ensure regulatory compliance, with a focus on patient safety.
- Provide management and leadership by supervising one or more other regional regulatory leads and/or support staff.
- Execute the approved regional strategy for assigned programs.
- Advise the GRT on regional considerations in developing strategy.
- Ensure the regional needs are well defined and implemented in collaboration with relevant regional partners.
- Plan and lead regulatory submissions (e.g. clinical trial and marketing applications) for products within Biotech’s portfolio in compliance with global filing plans and local regulatory requirements.
- Under general supervision, implement product related regulatory strategies, Regulatory Affairs processes and activity planning in accordance with national legislation and regulatory requirements.
- Provide content guidance for regional regulatory documents and meetings in accordance with GRT strategy.
- Provide regulatory guidance on regional regulatory mechanisms to optimize product development (e.g. expediting FIH studies, Orphan Drug, Fast Track, compassionate use and pediatric plan).
- Manage the development of the regional product label by collaborating with the Labeling Working Group to define commercial objectives in the context of available and expected scientific data, regulatory guidance and precedent.
- Support regional label negotiation activities.
- Under general supervision participate in the development, and execution of regional regulatory product strategies, including precedence, risk management and contingency planning.
- Consistent with GRT strategy, advise GDT on regulatory implications and requirements related to global clinical development plans and objectives
- Obtain and maintain Clinical Trial Authorizations and Marketing Application approvals including Response to Questions (RTQs)
- Communicate regulatory strategies within team (e.g. GRT, local affiliates).
- Under general supervision, develop predictions for expectations and risks associated with outcomes by regulatory agencies.
- Ensure regulatory product compliance for product (e.g. IMR, PMCs, pediatric and other agency commitments).
- Communicate and ensure alignment of regional management before GRT strategy decisions.
- Partner with management and peers to ensure consistency in procedures and agency interactions.
- Maintain an awareness of new and developing legislation, regulatory policy and technical Regulatory guidance relating to Biotech’s products.
- Perform regulatory research to acquire histories, precedence, and information pertinent to regional product advancement.
- Doctorate Degree OR
- Master's Degree & 3 years of Regulatory experience OR
- Bachelor's Degree & 5 years of Regulatory experience OR
- Associate's degree & 10 years of Regulatory experience OR
- High school diploma/GED & 12 years of Regulatory experience
- Regulatory submissions experience
- Experience interacting with regulatory agencies
- Clinical Development experience
- Cross-functional experience Knowledge and Skills
- Regulatory principles
- Working with policies, procedures and SOP’s
- Knowledge of national legislation and regulations relating to medicinal products
- Awareness of the registration procedures in region for MA, post approval changes, extensions and renewals
- Knowledge of drug development Scientific / Technical Excellence
- Communication skills – both oral and written
- Ability to understand and communicate scientific/clinical information
- Ability to anticipate and prevent potential issues
- Knowledge of and experience in regional regulatory environment in relevant product area and development stage
- Understanding of regulatory activities and their touch points
- Ability to resolve conflicts and develop a course of action leading to a beneficial outcome
- Cultural awareness and sensitivity to achieve results across both regional country and International borders