Our Team, Your ImpactThe Associate Director, Global Regulatory Affairs, will be responsible for supporting development of innovative molecules and combination products, as well as to ensure efficient management of approved and marketed products. The responsibilities of the role include compiling, organizing, and assessing documents for regulatory submissions to major market health authorities as well as coordinating with global regulatory colleagues in preparing dossiers for global registration.
Under the guidance of the Director, the successful candidate will provide the RA CMC strategy and submission support for commercial, and/ or early/late stage development programs as well as marketed products for biologics. The individual will interface with development, analytical, quality and manufacturing groups across the Teva network, as well as with internal regulatory departments. The Associate Director, Regulatory Affairs CMC will lead cross functional product teams for CMC specific projects and contribute to the planning and conduct of meetings with Health Agencies.
How You'll Spend Your Day- -As a lead within a global regulatory team, develops/coordinates/implements regulatory CMC strategy as a valued member of a multi-disciplinary project team for innovative products.
- -With guidance from the Director, plans and directs projects and provides technical background and consultation to cross-functional colleagues as well as members of the global regulatory team.
- -Critically reviews CMC aspects of submissions for accuracy of content, completeness, and compliance with applicable regulations or guidance. Perform gap analyses and work with functional areas to address deficiencies.
- -Perform change management to establish the regulatory impact of changes and ensure compliance of registered commitments
- -Manage day-to-day project activities related to assigned products. Support maintenance activities for investigational new drug applications (INDs), new drug applications (NDAs) and/or biologic license applications (BLAs).
- -Correspond with and respond to inquiries from regulatory agencies.
- -Assist in implementation of electronic document management system in the department.
- -Plan and oversee the compilation of FDA submissions, including initial INDs, original and supplemental NDAs/BLAs, annual reports, responses to Requests for Information, etc.
- -Maintains thorough knowledge of the laws, regulations and guidelines covering pre and post approval regulatory requirements and application maintenance.
Your Skills and Experience- -Bachelor degree in scientific field or equivalent combination of education and related work experience.
- -At least 5 years of regulatory affairs or relevant pharmaceutical industry experience.
- -Must be familiar with IND and/or NDA/BLA submission requirements.
- -Working knowledge of FDA/EMA regulations / guidance applicable to registration and approval of drugs or biologics.
- -Excellent communication and organizational skills.
Salary RangeHow We'll Take Care of YouWe offer a competitive benefits package, including:
• Comprehensive Health Insurance: Medical, Dental, Vision, and Prescription coverage starting on the first day of employment, providing the employee enrolls.
• Retirement Savings: 401(k) with employer match, up to 6% and an annual 3.75% Defined Contribution to the 401k plan.
• Time Off: Paid Time Off including vacation, sick/safe time, caretaker time, 13 paid Holidays and 3 paid floating holidays.
• Life and Disability Protection: Company paid Life and Disability insurance.
• Additional benefits include, but not limited to, Employee Assistance Program, Employee Stock Purchase Plan, Tuition Assistance, Flexible Spending Accounts, Health Savings Account, Life Style Spending Account, Volunteer Time Off, Paid Parental Leave, if eligible , Family Building Benefits, Virtual Physical Therapy, Accident, Critical Illness and Hospital Indemnity Insurances, Identity Theft Protection, Legal Plan, Voluntary Life Insurance and Long Term Disability and more
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