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Regulatory Affairs Manager II Job

Company Name:
Yoh
Regulatory Affairs
manager
II
job
Regulatory Affairs Manager II needed for a contract opportunity with Yoh's client located in Thousand Oaks, CA. The Big Picture: - To ensure that Client acquires and maintains all the required licenses in order to support clinical trials for investigational medicinal products as well as market commercially approved medicinal products - To ensure regulatory compliance, with a focus on patient safety - Ensuring the regional needs are well defined and implemented in collaboration with relevant regional stakeholders What You'll Be Doing: - As a member of the Global Regulatory Team (GRT), you will achieve the desired labeling by developing and executing regional regulatory strategies and managing effective agency interactions. - As requested this role may provide management and leadership by supervising one or more other regional regulatory leads and/or support staff (dependent on grade) - Advising the GRT on regional considerations in developing strategy - May manage one or more regional leads or support roles - May participate as a member of: - Global Regulatory Team (GRT), Global Development Team (GDT), Clinical Study Team (CST), Label Working Group (LWG), Regional Teams (eg IMT, IBT, NAMT) Health Authority Interactions - Act as a contact with national regulatory agencies in fulfilling local obligations by product assignment - Document and communicate details and outcomes of regulatory agency interactions to GRT and relevant sr. management - Under general supervision participates in core regulatory activities to ensure effective regional agency interactions consistent with the Global Regulatory strategy-includes contingency regulatory planning/risk assessment Region Specific Activities - US: Advises and supports promotion group regarding applicability of data for product communication in the US - EU: Review and approve promotional and non-promotional materials for use in the region - EM: Manage the product life cycle for individual countries per national agency requirements - EM: Work through the regional leads to manage distributor markets Strategy and Execution - Plans and manages regulatory submissions (eg clinical trial and marketing applications) for products within Client's portfolio in compliance with global filing plans and local regulatory requirements. - Under general supervision, implements product related regulatory strategies, Regulatory Affairs processes and activity planning in accordance with national legislation and regulatory requirements. - Provides content guidance for regional regulatory documents and meetings in accordance with GRT strategy - Provides regulatory guidance on regional regulatory mechanisms to optimize product development (eg expediting FIH studies, Orphan Drug, Fast Track, compassionate use and pediatric plan) - Manages in 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. - Supports 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 What You Need to Bring to the Table: - 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. - 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 - Knowledge of drug development - Experience and Skill in the following: - Regulatory principles - Working with policies, procedures and SOP's - Team work - Communication skills - both oral and written - Cultural awareness and sensitivity to achieve results across both regional country and International borders. - Planning and organizing - Managing multiple activities - Problem solving - Setting priorities - Action orientated - Working in teams - Presentation Skills - Leadership skills What are you waiting for? Apply Now! Recruiter: Salima Hakim Yoh, a Day and Zimmermann company, is an Equal Opportunity Employer, M/F/D/V. J2W: SCIENTIFIC; J2W: CLINICALJ2WSWSCI Ref: SFSF: LS MYK62683JR

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