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Associate Director, Regulatory Affairs
4 months ago
Who we are Together, we're on a mission to make good health more affordable and accessible, to help millions around the world enjoy healthier lives. It's a mission that bonds our people across nearly 60 countries and a rich, diverse variety of nationalities and backgrounds. Working here means working with the world's leading manufacturer of generic medicines, and the proud producer of many of the products on the World Health Organization's Essential Medicines List. Today, at least 200 million people around the world take one of our medicines every single day. An amazing number, but we're always looking for new ways to continue making a difference, and new people to make a difference with. How you'll spend your day As the Associate Director, Regulatory Affairs you will be responsible for acting as and supporting the Global Regulatory Lead (GRL) in strategic vision and innovative scientific and regulatory leadership in defining the global regulatory strategy for biosimilar (BioS) projects. You will be accountable to lead and/or support the Global Regulatory Affairs (GRA) Team for assigned projects to ensure alignment of the regional, clinical and Chemistry Manufacturing and Controls (CMC) regulatory strategies with the overall global strategy. In addition you will have responsibility for ensuring and assisting other GRLs in ensuring collaboration with key internal stakeholders of the Core Project Team (CPT), Clinical Development Team (CDT), and CMC Team to ensure successful planning and execution of the global regulatory strategy for assigned projects. Other duties: * Spearhead the delivery of successful investigational and regulatory license applications and product life cycle management submissions with the Global Regulatory Affairs Team from initial filing through post-approval management * Provide proactive support the regional strategic leads on the establishment and maintenance of high quality working relationships with the FDA, EMA, PMDA and other global regulatory agencies as appropriate for assigned products * Drive regulatory strategic decision making necessary to ensure planning and execution of successful global regulatory strategies, submissions and approvals for assigned biosimilar project(s) * Interface with project teams and regulatory agencies and proven skill at developing and implementing successful global regulatory strategies * Effectively manage a team/direct reports to ensure successful planning and execution of the global regulatory strategy for assigned projects Your experience and qualifications Required: * Bachelor's degree in Pharmacy, Biology, Chemistry or other related life science * Minimum 7 years of experience in the biotech/pharmaceutical industry (or equivalent) * Minimum 5 years of experience in regulatory (or equivalent) * Minimum 3 years of experience in leading and managing matrix teams (or equivalent) Preferred: * Advanced degree (MS/PhD in pharmacy, biology, chemistry, pharmacology or related life science, MBA, or MD) * Minimum 10 years of experience in the biotech/pharmaceutical industry * Minimum 7 years of experience in regulatory and minimum 3 years in commercial organization * Minimum 5 years of experience in leading and managing matrix teams * Minimum 3 years of experience working with biologics/biosimilars * Minimum 3 years of experience working with sterile products/manufacturing within biotech/pharmaceutical industry * Knowledge and understanding of pharmaceutical/biological/biosimilar product development and regulatory requirements for product development and approval in more than one key region (EU, US, Canada, Japan) as well as life cycle management of products * Experience working in Regulatory Affairs in a global environment across two or more geographic areas (preferentially US and EU) * Experience in evaluating Change Requests/Change Controls for regulatory documents and providing accurate regulatory assessments Enjoy a more rewarding choice We offer a competitive benefits package, including Medical, Dental, Vision, and Prescription coverage starting on the first day. We also offer Disability and Life Insurance, Paid Time Off, 13 paid Holidays, 6% match on the 401(k), Employee Stock Purchase Plan, and Tuition Assistance. Already Working @TEVA? If you are a current Teva employee, please apply using the internal career site available on "Employee Central". By doing so, your application will be treated with priority. You will also be able to see opportunities that are open exclusively to Teva employees. Use the following link to search and apply: Internal Career Site The internal career site is available from your home network as well. If you have trouble accessing your EC account, please contact your local HR/IT partner. Teva's Equal Employment Opportunity Commitment Teva Pharmaceuticals is committed to equal opportunity in employment. It is Teva's 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. Important notice to Employment Agencies - Please Read Carefully Teva Pharmaceuticals USA does not accept unsolicited assistance from agencies for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.
