Associate Director, Regulatory Affairs CMC

Employer
Location
Waltham, MA
Salary
Competitive salary and benefits
Posted
Jun 02, 2018
Closes
Aug 02, 2018
Education
BS
Career Fair Category
Career Fair

Associate Director, Regulatory Affairs CMC

There is nothing conditional about what we do.
Or who we are.
Or how we treat you.
We do what’s right.
We put science for patients first,
disrupting the model to go beyond
the concepts of conventional care.
We don’t treat a condition.
We treat people & partners.
We care to change the future.

Your Impact at TESARO:

ensure that TESARO is executing regulatory strategies and supporting interactions with regulatory authorities as appropriate.  Plan and coordinate regulatory submissions necessary to support clinical development, registration and commercialization plans for the biologic products to meet global regulatory requirements and company goals.

Job Responsibilities:

• Lead the regulatory Chemistry, Manufacturing and Controls (CMC) strategy for the assigned clinical and/or licensed biologic products

• Provide regulatory guidance to various departments, projects, and teams with a strong emphasis on frequent interactions with technical teams

• Contribute to the development and implementation of short and long term regulatory strategies for assigned projects and programs

• Plan, prepare and review regulatory authority submissions (CMC supplements, amendments, Agency meeting requests)  for assigned projects to ensure alignment with Health Authority requirements from a global perspective

• Review technical documentation and recommend changes as appropriate to ensure regulatory compliance and conformance with existing regulatory approvals and/or expectations

• Ensure maintenance of product license applications as assigned, by preparing pharmaceutical quality related content for Annual Reports, DSURs, and Commitment Responses using company systems and databases

• Provide interpretive analyses regarding impact of complex regulatory guidance documents, regulations, or directives that impact company products and operations

Requirements:

• BA/BS in science discipline and at least 7 years of biopharmaceutical regulatory experience.  Master’s or PhD degree is a plus 

• Solid understanding of FDA regulations and ICH guidance pertaining to biopharmaceutical product development and post marketing requirements

• Experience preparing INDs, BLAs / NDAs, and supportive amendments and supplements, including writing ICH Module 2 and Module 3 documents

• Experience with international regulatory applications is a plus

TESARO is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status.

FOR MORE INFORMATION, PLEASE CONTACT US AT
careers2@tesarobio.com