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Description
Assoc Dir Regulatory Affairs Job Details | Teva Pharmaceuticals Find a Career With Purpose at Teva Search by Postal Code Select how often (in days) to receive an alert: Select how often (in days) to receive an alert: Assoc Dir Regulatory Affairs Who we are The opportunity This is a senior position within the regulatory team supporting the International Markets business unit. The individual will be responsible to lead and proactively manage a team of Regulatory Managers who work on regulatory life cycle management activities for a mature innovator portfolio covering EU, US and other International Markets. This is a leadership position that is accountable for hiring, training and retention of regulatory staff in the team in alignment with the objectives of the Global Regulatory Organization. The Lead is also involved in continuous improvement and looking at new tools/technologies to improve efficiencies in ways of working. How you ll spend your day Accountable to support all activities related to Regulatory Life Cycle Management activities in Worldwide Markets (EU, US, Other Markets: CMC Variations, Renewals, PSUR, RMP, safety variations etc) Hiring, Training and Retention of Staff in the team Work closely with Worldwide markets, assesses dossier suitability and creates a submission tracker for all assigned products to ensure appropriate planning and prioritization. Work closely with global regulatory teams in the EU/US/Other International Markets to support Life Cycle Management activities within Regulatory Affairs Coordinate responses to Health Authorities, with appropriate personnel and departments to resolve outstanding regulatory issues. Ensure that cross-functional activities to support submissions and works collaboratively with Market RA to ensure all requirements are met and dossiers are submitted as per the submission plan. Establish vision for the team, team building activities, planning and prioritization of daily work and regular business updates to management. Your experience and qualifications B. Pharmacy/M. Pharmacy/MSc/Ph. Din Biology/Chemistry Experience: 12 to 15 years in RA Expertise in global regulatory strategies and life cycle management activities for Worldwide Markets Ability to work proactively and independently in a global environment Ability to plan, organize and execute projects as required within Global Regulatory Affairs Strong Leadership Experience with ability to build a collaborative environment within the team with positive work culture and develop junior staff members. Personal Characteristics Good leadership, project management and communication skills Excellent analytical, problem-solving, and self-learning skills. Ability to work independently and effectively in a cross-functional team environment;manage multiple projects simultaneously. Detail-oriented with a high level of accuracy in work deliverables. Strong organizational and time management skills. Excellent spoken and written English is essential. Teva s Equal Employment Opportunity Commitment Teva Pharmaceuticals is committed to equal opportunity in employment. It is Tevas global policy that equal employment opportunity be provided without regard to age, race, creed, color, religion, sex, disability, pregnancy, medical condition, sexual orientation, gender identity or expression, ancestry, veteran status, national or ethnic origin or any other legally recognized status entitled to protection under applicable laws. We are committed to a diverse and inclusive workplace for all. If you are contacted for a job opportunity, please advise us of any accommodations needed to support you throughout the recruitment and selection process. All accommodation information provided will be treated as confidential and used only for the purpose of providing an accessible candidate experience.
