Regulatory Affairs Intern 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.

Management review of quality and regulatory team.

Manage the preparation and development of regulatory submission packages.

Oversee document control, internal and external audits, complaint system, CAPA, NCMRs, and key supplier qualifications.

Prior experience authoring and filing of regulatory documents.

Responsible for regulatory submission strategies to support product development and approval of various medical device products.

Interface with regulatory authorities and internal technical teams on regulatory submissions.

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.

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

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.

Support 510(k) reviews (if sufficient experience)

Excellent verbal and written communication skills

Experience in a collaborative cross-functional development environment

Experience with FDA’s ecopy submission template a plus

Assist with 510(k) IDE drafting/compilation

Assist with 510(k) ecopy and submission

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

Proven experience in regulatory management of centrally approved products

Manage the Labelling and packaging material supply

2-5 years of pharmaceutical industry regulatory experience

Experience in New Drug Applications

Experience in the preparation of CTAs to support clinical trials

Keep up to date with regulatory and legal changes across all markets

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

3-5+ years of professional OUS EUMDR Regulatory Affairs experience

Experience with Medical Device Reg Affairs for implantable

Working knowledge of 21 CFR 820, ISO 13485, MDD, EU MDR, and MDSAP

Full Benefits: Medical, Dental, Vision for employee and all dependents!

Bleeding Edge Technology = smart device to control pain relief!

Maintain licenses/registrations in existing territories

BA/BS or equivalent education with 1-3 years of relevant experience in Regulatory Affairs or related area. Advanced degree desirable.

Knowledgeable of GCP requirements and FDA guidelines

Demonstrates strategic thinking skills, and has the ability to drive projects based on group objectives

Excellent writing and organizational skills, and an ability to generate clear, concise documents

Strong planning and multitasking skills.

Essential Functions and Job Responsibilities:

Assists in the management of CalOptima Health’s daily relationship with the DHCS for CalOptima Health’s Medi-Cal program.

Assists in the management of CalOptima Health’s daily relationship with the DMHC.

Maintains open lines of communication to ensure the ongoing trust and confidence of regulators in the program and management.

3 years of experience in government, public or government affairs role in health care compliance or health plan requirements required.

Assists the team in carrying out department responsibilities and collaborates with others to support short- and long-term goals/priorities for the department.

Experience working with regulatory agencies in California.

Provides strategic guidance on global regulatory requirements to management and project teams

Detailed knowledge of FDA/EMA/ICH regulations and guidance for global drug development, preparation and management of IND/CTA/MAA/BLA/NDA applications

Regulatory experience and detailed knowledge outside the US (Japan and/or EU) is preferred

Manages preparation of all regulatory submissions (IND/CTA/MAA/BLA/NDA)

Master's degree preferred and 15+ years of related experience, OR

PhD and 12+ years of related experience OR

Understanding of product life cycle process, design control and/or risk management.

Participate on product development core teams as regulatory representative and provide guidance on global regulatory requirements for new/existing products.

Interpret and clearly explain regulatory requirements and standards for IVDs and medical device products to cross-functional stakeholders.

Prepare/manage internal procedures for continuous process improvement. Provide guidance on new or revised procedures and policies (as assigned).

Bachelors with 1 years of experience or Masters with 0 year of industry experience or equivalent

Technical knowledge including (but not limited to) Biomedical/Life Sciences/Engineering/Clinical.

Interfaces with management and department.

Complies with management direction. Seeks assistance from supervisor in identifying and reporting problems or concerns relating to job functions.

Conducts self in a professional manner with colleagues, management, customers, and others. Models the corporate values.

Maintains contracts and invoice coordination with respect to Regulatory requirements.

No significant travel. Occasional requirements to attend offsite meetings.

Have attention to detail with organizational skills

Direct experience with Medical Device Software regulations IEC 62304 / 82304, IEC 60601.

5+ year's validated experience with regulated medical device development.

Validated understanding of QMS, demonstrating experience in supporting QMS process implementation using methodologies that promote compliant and agile software development practices.

Minimum of 5 years’ validated experience working with US 510(k)/PMA and CE Tech Files including software-driven medical devices and related products.

Knowledge of hardware-based device development, compliance testing, and documentation (i.e., traceability, integration, verification) a plus.

Certifications (RAC, CQA, CQM, etc.) preferred.

Good project management skills, as evidenced by ability to manage multiple assignments simultaneously without compromise to timelines or quality.

Knowledgeable with the drug development process, cell therapy industry, and Regulatory practices; eCTD submission experience highly preferred

Helps expedite and improve regulatory administrative activities by training and advising new or less experienced colleagues.

Ensures own work complies with established practices, policies and processes, and any regulatory or other requirements.

Master’s and 2+ years of relevant experience OR

Bachelor’s and 4+ years of relevant experience OR