Associate Director, Regulatory Affairs CMC (Biologics, Combination Products)

Teva Pharmaceutical; West Chester (Chester County); Vor Ort; USD 140.000 - 185.000; Vollzeit

Benefits dieser Stelle

Health insurance

401(k) plan

Paid time off

Life and disability insurance

Employee stock purchase plan

Zusammenfassung

Teva Pharmaceuticals USA seeks an Associate Director, Global Regulatory Affairs CMC to lead regulatory CMC strategy for innovative and marketed products. You will interface with development, analytical, quality and manufacturing teams across Teva’s network and guide cross-functional projects in a multi-disciplinary setting.

The role involves coordinating with Health Agencies, planning FDA submissions (INDs/NDAs/BLAs), and ensuring regulatory compliance across global registration activities for

Qualifikationen

• Bachelor degree in scientific field or equivalent.
• 5+ years of regulatory affairs experience.
• Familiar with IND and/or NDA/BLA submissions.
• Knowledge of FDA/EMA regulations/guidance.

Aufgaben

• Develop/regulatory CMC strategy as part of a global team.
• Plan and direct regulatory projects; provide technical guidance.
• Review CMC submissions for accuracy and compliance.
• Coordinate with Health Agencies and cross-functional teams.
• Lead preparation of FDA submissions (INDs, NDAs, BLAs) and related reports.

Kenntnisse

Regulatory affairs

IND/NDA/BLA

FDA/EMA knowledge

Communication

Ausbildung

Bachelor's degree in science

Jobbeschreibung

We Are Teva

We're Teva, a leading innovative biopharmaceutical company, enabled by a world-class generics business. Whether it's innovating in the fields of neuroscience and immunology or delivering high-quality medicine worldwide, we're dedicated to addressing patients' needs now and in the future. Here, you will be part of a high-performing, inclusive culture that values fresh thinking and collaboration. You'll have the room to grow, the flexibility to balance life with work, and the opportunity to better health worldwide, together.

Our Team, Your Impact

The 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.

How We'll Take Care of You

• 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

Teva's Equal Employment Opportunity Commitment

Teva Pharmaceuticals is committed to equal opportunity in employment. It is Teva's policy that equal employment opportunity be provided without regard to age, race, creed, color, religion, sex, disability, pregnancy, medical condition, genetic information, marital status, sexual orientation, gender identity or expression, ancestry, national or ethnic origin, citizenship status, military status or status as a disabled or protected veteran, or any legally recognized status entitled to protection under applicable federal, state, or local laws.

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. Request a reasonable accommodation by sending an email to [e-mail] with the nature of your request and your contact information. Only inquiries concerning a request for a reasonable accommodation will be responded to from this email address.

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.