Regulatory Affairs Cmc Jobs

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)

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.

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;

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

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.

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.

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;

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

· Experienced in authoring of assessment reports and Part2/ Expert reports for Dossiers

· Knowledge ofregulatoryguidelines and relevant applications.

· Demonstrate effective leadership, communication, interpersonal skills, and soft skills.

Inviting applications for the role of CMC 3 Manager-RegulatoryAffairs !

Qualifications we seek in you!

• Proven and relevantregulatoryaffairs experience in pharmaceutical, vaccine, or biological products; or related fields

Professional experience in regulatory project management/program management and regulatory agency interactions.

Demonstrated life-long learner; eagerness to obtain new skills and knowledge.

Reviews and approves advertising and promotion material to ensure consistency with approved claims and regulatory requirements.

Proved work experience in heavily regulated fields such as medical devices, pharmaceuticals, or biologics.

Professional experience in Regulatory Affairs / Quality Assurance.

Experience with Software as a Medical Device (SaMD), cybersecurity, and other non-device software products.

Communicate to the Operations Manager, Director of Quality, or other Senior Management as appropriate any potential issue.

An experienced formulation and applications team

Prior experience working with documentation pertaining to nutritional supplements and ingredients

Good analytical problem-solving skills. Meticulous with follow-up

Good communication skills. Able to give clear directions to others.

Quality Assurance, Compliance, Labelling, Documentation, and Regulatory Requirements

BS in a quantitative or scientific discipline with 4+ years of relevant data science/analytics experience in the pharmaceutical industry

Experienced with computer languages (R, Python, SQL, etc.) and statistical software packages (JMP, Statistica, Minitab, etc.) to manipulate and analyze data

Experienced with business informatics tools (e.g. Tableau, Power BI, Spotfire)

Prior experience working in a GMP environment and understanding of bioprocessing unit operations is a must

Drive and support data pipeline initiatives

Engage with the delivery of new process analytics tools cross-functionally

Experience with prep and filing of the following applications: FDA IND/ANDA/NDA/BLA applications and maintenance submissions

Experience with leading cross-functional teams

As the roles can range, it would be ideal to have experience with the following:

5+ years in Regulatory Affairs (ex: generics, prescription drugs and biologics)

May require up to 10% travel

This would be a contract role, and they are open to either full-time or part-time capacity.

Project management experience with excellent interpersonal, presentation and communication skills.

Three or more years complex worldwide CMC regulatory strategies/requirements and demonstrated ability to influence the global internal/external regulatory environment. 

Two or more years of experience managing and directing multiple projects/teams in a high matrix environment.

One or more years of experience fulfilling a key role in major filing activities.

Experienced in supervising and training junior staff and the ability to motivate and lead others.

Managing the global CMC regulatory activities for multiple projects/teams simultaneously and respond readily to changing events and priorities.

8 to 12 years’ experience working in a regulated, life science environment with Strong project management interpersonal skills.

Experienced in defining Organizational Strategy, Process and Change Management, KPIs and Metrics, Project Management, Resource Forecasting.

Develop and manage day-to-day operations through the use of project management and planning tools, create and maintain detailed project timelines.

Responsible for Product lifecycle management & plan for global regulatory filings and assessments as required by the individual project.

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

Should have demonstrated ability to manage the product life cycle submissions in key regulated markets like US, Canada, UK & EU.