Cmc Regulatory Affairs Jobs in California

Level of Education and Discipline:

Participate in paid on-call rotation and other job-related duties as assigned.

May perform related duties and activities as assigned.

Adheres to and supports the Core Values of the ISO.

Required Knowledge Skills & Abilities

· Working knowledge of statistics, investments, budgeting, project management and computerized applications.

· The Regulatory Affairs Analyst requires substantial technical skill in finance, economics, and statistics.

· Utility rate-making methodologies and legal requirements.

· Excellent written and oral communication skills.

· A bachelor's degree or equivalent in finance, economics, accounting, engineering or a closely related field.

Lead and manage multiple and concurrent drug substance projects, with responsibilities including:

Excellent written and oral communication skills, including experience in technical writing in support of regulatory submissions.

Good organizational skills and the ability to manage multiple competing priorities.

Lead and manage formulation development, which may entail one or more of

Experience working, collaborating with, and managing CDMOs.

Good knowledge of formulation options and troubleshooting

Develop, lead, and drive the execution of the regulatory strategy from pre-IND to launch, commercialization and product lifecycle management

Responsible for communicating business-related issues or opportunities to next management level

Plan and oversee activities in support of all regulatory submissions

Provide regulatory guidance to the Client across all areas of regulatory affairs throughout all stages from product development

Participate as part of internal regulatory team to define and execute the regulatory strategy

Support the preparation of briefing packages, and regulatory submission documents as needed , providing insight and expertise

Strong sense of planning and prioritization, and the ability to work with all levels of management.

Ensure that CMC content is complete, well-written, and meets all relevant requirements.

Manage regulatory assessment and guidance on product compliance topics including change controls, deviations, and GMP/quality investigations throughout development.

Biologics experience required; cell or gene therapy experience strongly preferred. Medical device experience also preferred.

Excellent interpersonal skills to communicate difficult concepts and persuade others.

Strategic thinking and strong problem-solving skills with outstanding attention to detail.

Proven people management experience, with a track record of building and leading high-performing teams

Participate in the development and implementation of regulatory strategies to support product approvals, license maintenance, and lifecycle management

Collaborate with cross-functional teams to ensure that regulatory requirements are integrated into product development plans and timelines

Strong knowledge of FDA, EMA, and other global agencies' regulations related to CMC submissions for generics and NCEs

Excellent writing, communication, and interpersonal skills

Prepare and maintain CMC documentation for various applications, including NDAs, DMFs, CEPs, INDs, etc.

May require an advanced degree and 5-8 years of direct experience in the field.

Recent experience with Class III implantable medical devices

Knowledge of FDA PMA guidance documents and CFR regulations.

Relies on extensive experience and judgment to plan and accomplish goals.

Typically reports to a manager or head of a unit/department.

knowledge of FDA PMA guidance documents and CFR regulations.

Monitor current and proposed regulatory issues and trends and advise management on events of significance for Exelixis’ business interests.

Equivalent combination of education and experience.

Deep knowledge and understanding of the drug development process and regulatory requirements and environment

Strong interpersonal skills and the ability to skillfully and appropriately manage, develop and mentor personnel in a matrix environment

Provide Regulatory assessment to due diligence teams in terms of risks, requirements, and opportunities associated with potential in-licensed assets

Bachelor’s degree in related discipline and a minimum of twenty-one years of related experience; or,

Extensive experience and knowledge required of global medical device regulations, requirements, and standards;

Leading strategic AOP management to optimize revenue

10 years of people management – with a strong track-record in successfully leading a Regulatory Affairs team

Experienced in strategic relationships with external stakeholders (e.g. Notified Bodies, FDA, Competent Authorities);

*Montana employees are currently excluded from this requirement at this time.

In return, we offer you

Experience with global regulations and/or CE marking beneficial.

Relies on experience and judgment to plan and accomplish goals. Performs a variety of tasks.

Typically reports to a manager.

May lead and direct the work of others.

A wide degree of creativity and latitude is expected.

Job Title: Regulatory Affairs Associate

In-depth knowledge of global regulatory requirements

Establish and maintain relationships with senior regulatory consultants and advisors; manages regulatory vendors and budget

Ensure compliance with applicable regulatory reporting requirements, laws and regulations

Science degree (PhD, PharmD, MD, MSc) with extensive experience in regulatory leadership

Minimum of 10 years of experience in Regulatory Affairs in the biopharmaceutical industry

Prior experience in dermatology or immunology and inflammation preferred