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Regulatory Program Manager, Pharma Technical Regulatory (CMC)

Company: Genentech
Location: Oceanside
Posted on: November 24, 2022

Job Description:

The Position

We currently have an opportunity for a Regulatory Program Manager to join our global Pharma Technical Regulatory team.

Job Responsibilities:

* Responsible for the development, communication and execution of sound regulatory strategies that meet global regulatory requirements and enable business objectives, including identification and communication of regulatory risks and development and execution of risk mitigation strategies in concert with technical functions.

* Responsible for submissions of high quality CMC regulatory documents to health authorities in accordance with current Good Manufacturing Practices (cGMP), Roche corporate standards and the requirements of applicable health authorities and other regulatory agencies.

* Management of regulatory changes throughout the product life cycle. Provide regulatory support for relevant quality systems such as change control, discrepancy management, as well as Health Authority inspection support as required.

* Coordinating health authority interactions for assigned projects; representing Technical Regulatory at multidisciplinary meetings.

* Representation of PTR on cross-functional technical and regulatory project teams.

* Contributing to regulatory excellence by identifying opportunities, mitigating risks and supporting continuous improvement.

* Leading regulatory projects in collaboration with other technical regulatory professionals.

* Contribute to driving efficiency by assertively simplifying, taking risk and cutting out waste.

Job Qualifications:

* Must have a Bachelor's degree - preferably in a scientific field; an advanced degree is a plus.

* A minimum of 5 years work experience in the pharmaceutical, biotechnology or related industry and CMC, quality, regulatory or related experience.

* A regulatory professional with a depth of technical experience and knowledge and the ability to manage complex issues with efficiency.

* Experience in CMC regulatory considerations for biologics is preferred; other modalities including small molecules, device/combination products, etc. as well as Marketed Products are an advantage.

* You should bring experience in technical (CMC) development, sound knowledge of global regulations and successful management of complex regulatory submissions. Interaction with Health Authorities is a plus.

* Leader who is an agile strategic thinker with exceptional communication skills.

* Possesses the ability to work effectively both within a team environment and independently.

* Ability to influence teams and functions in defining global technical regulatory strategies.

* You are comfortable with taking risks, experimentation and ambiguity


Please note the positions can be located in South San Francisco CA, as well as Vacaville CA, Oceanside CA or Hillsboro, OR. *Flexible work arrangements and remote work from a US-based location outside of commuting distance from a Genentech location, will be considered

For Colorado-based applicants, the expected salary range for this position is $94,500-$106,000. Actual pay will be determined based on experience, qualifications, and other job-related factors permitted by law. A discretionary annual bonus may be available based on individual and Company performance. This position also qualifies for the benefits listed below.


* Roche offers highly competitive benefit plans and programs, including:

* Medical, dental and vision insurance

* 401(k) and 401(k) matching

* Paid time off

* Roche Long Term Incentive Plan (available at certain position levels)

Support Genentech's mission of advancing and boldly championing diversity, equity, and inclusion

Genentech is an equal opportunity employer, and we embrace the increasingly diverse world around us. Genentech prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity or expression, national origin or ancestry, age, disability, marital status and veteran status.

Genentech requires all new hires to be fully vaccinated against COVID-19 as of their start date. This requirement is a condition of employment at Genentech, and it applies regardless of whether the position is located at a Genentech campus or is fully remote. If you are unable to receive the vaccine due to a disability or serious medical condition, or because it is prohibited as a result of your sincerely held religious beliefs, you will have an opportunity to request a reasonable accommodation.

Keywords: Genentech, Oceanside , Regulatory Program Manager, Pharma Technical Regulatory (CMC), IT / Software / Systems , Oceanside, California

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