Intern - Product Development - Regulatory Program Management

Job description

  Job facts

Start Date: ASAP or May/June 2018
Length of Assignment: 6 months - 1 Year

Regulatory Program Management is part of the broader Product Development
Regulatory (PDR) organization that interprets the needs of worldwide health authorities
and provides regulatory intelligence necessary to generate and present information that
meets the needs of health authorities, patients, purchasers and prescribers for Roche's
global Pharma Medicines Division, which includes all therapeutic areas and all phases of
product development from early development to post-marketing. PDR is responsible for
the timely submission of applications to health authorities for approval of new products
and line extensions. PDR is committed to regulatory strategies that are the most
innovative, ethical, and influential in the industry. Like others in Regulatory Program
Management, interns are assigned their responsibilities by therapeutic area, and are
assigned projects for different product development phases, as business needs dictate.

Regulatory Program Management interns support regulatory program management for
one or more development projects. Regulatory Program Management interns participate
in and support the development and implementation of regulatory strategies to facilitate
the development and approval of Roche medicines for human use. Interns are expected
to perform their responsibilities with supervision. Regulatory Program Management
interns may work cross-functionally and help coordinate regulatory-related activities
across PDR functions and with other internal partners.

Interns participate directly with a Regulatory Team within one or more of our current
molecular teams. This is an opportunity to explore the regulatory clinical and non-clinical
parts of R&D in a business environment. The internships are typically 6 months duration
with possible extensions, therefore students should have completed or nearing
completion of their degree when applying. This position is based in South San
Francisco, California.

About PDR
In PDR, we seek to deliver global regulatory strategies, intelligence and knowledge. We
propose innovative solutions that balance risk and reward for all stakeholders and shape
the regulatory environment. We do this by translating Health Authorities (HAs)
requirements into dossiers and labels, by providing advice on interactions with HAs, and
by taking care of molecules globally from labs to commercialization.

Our PDR Functions (Regulatory Business Office, Regulatory Regions & Policy,
Regulatory Strategic Support and Regulatory Therapeutic Areas) contribute to the
development of our regulatory strategies and our interactions with Health Authorities.
Regulatory colleagues work closely within PDR teams and with teams outside PDR to
ensure we support the overall goals of the Product Development organization.

·  Who we are

A member of the Roche Group, Genentech has been at the forefront of the biotechnology industry for more than 40 years, using human genetic information to develop novel medicines for serious and life-threatening diseases. Genentech has multiple therapies on the market for cancer & other serious illnesses. Please take this opportunity to learn about Genentech where we believe that our employees are our most important asset & are dedicated to remaining a great place to work.

Roche is an equal opportunity employer and strictly prohibits unlawful discrimination based upon an individual's race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, mental/physical disability, medical condition, marital status, veteran status, or any other characteristic protected by law.

If you have a disability and need an accommodation in connection with the on-line application process, please email us at .
EEO is the Law

PAY TRANSPARENCY NONDISCRIMINATION PROVISION
The contractor will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor's legal duty to furnish information. 41 CFR 60-1.35(c)

Desired profile

Who you are

In hiring new employees, we look for people who are also inspired by our mission and who would fit in well with the collaborative, rigorous and entrepreneurial spirit of the company culture. Because we know that employees are critical to our success in bringing novel medicines to patients, we are dedicated to remaining a great place to work and to providing employees with programs, services and benefits that allow them to bring the best to the business and to their personal lives.

The successful candidate will be nearing completion of a regulatory degree or science
(preferably in life sciences) degree; and/or is a graduate student or has recently
completed graduate studies (required to have academic studies within 2 years of
applying for this position).

·  Self-motivated/pro-active and with ability to multi-task.
·  Attention to detail and accuracy.
·  Excellent oral and written communication skills.
·  Proficient in Microsoft Office and general on-line research.
·  Excellent planning and organizational skills
·  Can learn and adapt quickly.
·  Works well with others and within teams
·