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.
The opportunity
As the Senior Manager, Regulatory Affairs you will be responsible for indirectly supporting the Global Regulatory Lead (GRL) in executing the GRL's strategic vision and innovative scientific and regulatory leadership to support biosimilar (BioS) projects. You will be accountable to support the Global Regulatory Affairs (GRA) Team for assigned projects to ensure execution of the regulatory strategy. In addition you will have responsibility for ensuring and assisting GRLs in ensuring collaboration with key internal stakeholders of the Core Project Team (CPT), Clinical Development Team (CDT), and CMC Team to ensure successful execution of the global regulatory strategy for assigned projects.
How you'll spend your day
As Sr. Manager, CMC Regulatory Affairs you will be responsible for managing the day-to-day chemistry, manufacturing, controls (CMC) regulatory activities for all assigned marketed products, as well as those products that are currently in development. You will be responsible for compiling, organizing, and assessing documents for regulatory submissions to health authorities (e.g., FDA, Health Canada) as well as working with global regulatory colleagues in preparing dossiers for products for global registration. You will be responsible for maintaining and updating CMC sections of submissions for assigned products.
As Sr. Manager CMC Regulatory Affairs you will also be responsible for identifying and evaluating CMC issues associated with development products, including product and process development, analytical methods, formulation development, manufacturing, and labeling. You will interface with development and manufacturing groups, as well as with internal regulatory departments, provide for support cross functional product teams for CMC specific projects and may assist in the planning and conduct of meetings with FDA.
Other duties:
Provide CMC regulatory guidance to teams engaged in the development of new products by assessing and interpreting FDA/ICH/EMEA regulatory guidance and directives, and evaluating and communicating their applicability to the development teams.
Coordinate, author and review the CMC sections of IND, BLA (351k) and CTA filings. Compile and review CMC regulatory documents, including but not limited to Development Reports, Validation Protocols and Reports, BLA supplements, IND and BLA Annual Reports, and Responses to FDA information requests. Assist in the submission of regulatory correspondence to the FDA.
Support the global registration initiative for marketed products by liaising with Regulatory counterparts in the Europe, Israel, Canada and Rest of World assisting with preparation of complete registration dossiers to be submitted to foreign Health Authorities.
Perform change management to establish the regulatory impact of changes and ensure compliance of registered commitments.
Assist in planning and conducting meetings with regulatory agencies for routine meetings and interactions.
Provide pro-active support of 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.
Accountable for supporting the strategic regulatory decisions and execution of successful global regulatory strategies, submissions and approvals for assigned biosimilar project(s).The Sr. Manager is accountable for interface with project teams and regulatory agencies and proven skill at executing global regulatory strategies.
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 participating in 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
Experience in leading and managing matrix teams (Minimum 5 years)
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?
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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.
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