Cmc Regulatory Affairs Jobs in Folsom, Sacramento, 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

Past Management Experience is a MUST

Will work and manage in-house and outsourced lab activities

Experience working amongst CMC leaders such as Regulatory, Analytical, and Quality

Experience overseeing outsourced vendors (CMOs/CDMOs)

Experience overlooking multiple drug candidates within the company's pipelines

M.S. or Ph.D. in Pharmaceutical Sciences or a related scientific field with ideally 10-15 years of industry experience

Develop and manage budgets for CMC operations, ensuring cost-effectiveness while maintaining high-quality standards

Forecast and manage the supply of drug product for clinical trials

A minimum of 10-12 years experience in pharmaceutical or biotechnology CMC development with regulatory interactions experience

Excellent cross-functional leadership, team building, and communication skills

Proven experience in tech transfer, manufacturing scale-up, and validation of biotechnology products

Hiring Manager Interview (45 minutes)

Critical thinking skills and ability to acquire and apply knowledge quickly;

Lead, manage and prepare clinical trial submissions;

Lead, manage, prepare, and submit meeting requests and meeting information packages to health agencies;

Lead, manage, prepare, and submit controlled correspondence to regulatory agencies;

8+ years of regulatory experience in an industry setting;

Strong knowledge of drug development and regulatory policy;

Compile materials required in submissions, license renewal and annual registrations and maintains updated information about national/regional/global regulatory requirements.

Maintain and updates information about global regulatory requirements.

4+ years of Regulatory Affairs experience

Post-graduate and/or certification/ license may be required.

Review product labeling and marketing materials for accuracy and compliance with regulations.

Respond to customers and/or authorities requests/inquiries dealing with regulations and product compliance.

Provide training to company managers and other relevant team members in areas related to regulatory compliance and associated best practices;

Conduct thorough research and stay up-to-date with US regulatory requirements, guidelines, and industry best practices pertaining to healthcare products and pharmaceuticals.

Minimum of 5 years of experience as a Regulatory Affairs Consultant in the healthcare industry, with a focus on US regulations;

In-depth knowledge of US FDA regulations and guidelines for drug and medical device development and approval processes;

Exceptional research, analytical, and problem-solving skills;

Excellent written and verbal communication skills;

Offer strategic regulatory counsel to senior management.

Management of a large, global product portfolio with a demonstrated ability to manage a wide array of simultaneous activities.

You must have at least 15 years of managerial experience in the medical devices sector.

Head a skilled, diverse regulatory affairs team adept at navigating global regulations.

Devise and execute strategies for prompt global product launch while adhering to regulations.

Assure comprehensive and lawful post-launch product backing.

Bachelors degree in a scientific discipline or relevant experience (post-graduate degree is preferred but not a requirement)

Experience working within US regulatory affairs within the pharmaceutical or healthcare industry

Experience of regulatory submissions and approvals, including new BLAs/NDAs

Experience with licensing including negotiating directly with the FDA

Salary - $150,000 to $160,000 plus excellent bonus and benefits

across their entire business. As part of this growth, the business is looking to hire an experienced

Develop and manage day-to-day operations using project management and planning tools, create and maintain detailed project timelines

Support delivery in performing project management activities or as an individual contributor for a deliverable, managing relationships with all stakeholders

Sound understanding of regulatory information management concepts and tools needed to perform regulatory operations priorities in support of all business areas

Ensure development programs are compliant with ICH regulatory requirements and all local country regulatory requirements

There is a travel requirement of up to 10%

Knowledge of IND/NDA/BLA submissions and life cycle submissions for the US market

Ensure sustained quality and efficiency through modern artwork management systems

Extensive experience working with Healthcare/Pharmaceutical product labelling

Consistently drive continuous improvement related to global Pharmaceutical labelling

Work highly cross-functionally with wider global teams, and educate global stakeholders of labelling best practices

Strong understanding of Pharmaceutical Regulatory Bodies across a global remit

Degree from a leading college

Minimum 12 years relevant experience out of which more than 5 years of people manager role

Responsible for Noram regulatory strategy of both products approved and products under development.

Will serve as the point of contact for the Agency’s interactions and act as local regulatory representative

Supports development of Noram regulatory policy priorities, generates policy positions, develops action plans.

Responsible to prepare, review and approval of module 1 sections in partnering with GRL and make them available for NDS submission

Assist North America head on product development strategy and participate in building the regulatory strategy.

Assist departmental management in providing regulatory guidance to other departments (QA, QC, Manufacturing, Technical Services, etc.) for planned changes.

Position functions autonomously and consults with departmental management on an as-needed basis.

Position is remote, but expected to be a normal office situation occurring during typical US business hours.

Access – Providing high quality trusted medicines regardless of geography or circumstance;

Leadership – Advancing sustainable operations and innovative solutions to improve patient health; and

Partnership – Leveraging our collective expertise to connect people to products and services.

Provide training to company managers and other relevant team members in areas related to regulatory compliance and associated best practices;

Conduct thorough research and stay up-to-date with US regulatory requirements, guidelines, and industry best practices pertaining to healthcare products and pharmaceuticals.

Minimum of 5 years of experience as a Regulatory Affairs Consultant in the healthcare industry, with a focus on US regulations;

In-depth knowledge of US FDA regulations and guidelines for drug and medical device development and approval processes;

Exceptional research, analytical, and problem-solving skills;

Excellent written and verbal communication skills;

Identify claims issues and lead/offer alternatives to comply with regulatory guidelines while supporting business needs.

Must be a solution oriented, self-starter with demonstrated problem solving skills.

Skilled in Excel and demonstrate accuracy with collecting and analyzing data.

Responsibilities include but are not limited to:

Lead regulatory functions and collaborate with cross-functional partners in support of the marketing review and documentation proofing process.

Regulatory Claim Subject Matter Expert (Marketing Support and Review)

Knowledge of FDA and Health Canada eCTD submissions lifecycle management and associated guidance’s/specifications/regulations.

Reports to labeling management in Regulatory Operations and Innovation.

Enters and monitors project and data in Regulatory Label Management systems (LIFT, SPL, ALiCE, novoGlow, etc.).

May be responsible for managing projects, processes, or programs with manager oversight.

Experience and/or Familiarity with Structured Content is preferred

Excellent verbal and written communication and skills.

Clinical experience and great customer service skills.

Medical knowledge in pediatric patients and vaccines.

The LVN is responsible for the direct and indirect care of the clinic patients.

The LVN assists the physician and/or mid-level provider providing care to patients.

Assist departmental management in providing regulatory guidance to other departments (QA, QC, Manufacturing, Technical Services, etc.) for planned changes.

Position functions autonomously and consults with departmental management on an as-needed basis.

Position is remote, but expected to be a normal office situation occurring during typical US business hours.

Key responsibilities for this role include:

The minimum qualifications for this role are:

Access – Providing high quality trusted medicines regardless of geography or circumstance;

Effectively monitor and track information and requirement changes

Maintain compliance with regulatory requirements and regulatory databases for generic drugs for the US market.

Adhere to all health, safety & environmental (HSE) requirements in support of departmental and site HSE goals

Excellent oral and written communication skills

Pharmaceutical or generic drug experience in a regulatory capacity

Lab experience and familiarity with Abbreviated New Drug Application (ANDA) and/or Electronic Common Technical Document (eCTD)

Deep knowledge of the relevant Regulatory requirements

Opportunity for international career development: a global network offering seminars and training sessions, expert and manager career paths

8+ years relevant experience within the Regulatory Affairs discipline

Ability to develop innovative strategies and creative solutions within the Regulatory context and within the scope of requirements/available resources.

Proven analytical skill and technical/scientific competence.

Strong initiation and organizational skills

-Thorough knowledge of relevant regulatory laws, guidelines, and industry standards in Products Certification and Inspection Activities.

-Excellent communication and negotiation skills to articulate regulatory requirements and advocate on behalf of Tabseer.

-Good relationship with top level of Saudi Regulators’ Management Team.

Job Title: Regulatory Affairs Manager

-Clarify any ambiguous regulatory points or requirements by engaging with regulators and coordinating with internal teams.

-Stay informed about changes in regulatory landscape and assess their impact on Tabseer's certification and inspection operations.