Manager, Regulatory Affairs

Company Info

Job Description

As the Manager, Regulatory Affairs you will be responsible for 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 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 the manager will have responsibility for assisting the GRL 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:

• The manager will assist in 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.
• Assist the GRL to pro-actively 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.
• Assist the GRL for 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 regulatory agencies and proven skill at developing and implementing successful global regulatory strategies

Qualifications

What you will bring to the role:

• Bachelor’s degree in Pharmacy, Biology, Chemistry or other related life science
• Minimum 7 years of experience in the biotech/pharmaceutical industry
• 5 years of experience in regulatory

Preferred Qualifications:

• Advanced degree
• Minimum 2 years management experience
• 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
• Experience working in a complex and matrix environment
• Experience in working with cross-functional teams and with multiple stakeholders

Function

Sub Function

Reports To

Director Regulatory Affairs Global Biosimilars

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.

Teva Pharmaceuticals USA requires all U.S. new hires to be fully vaccinated for COVID-19 prior to the first date of employment. As required by applicable law, however, Teva will consider requests for reasonable accommodations.