Cmc Regulatory Affairs Jobs in Bowie, Texas

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

Leads interactions with FDA and other Health Authorities for CMC-related topics (including management of regulatory deliverables and commitments).

Provides CMC Regulatory leadership, serving as an expert for global regulatory CMC requirements and emerging trends for cell therapy products.

Plans, execute, and manages regulatory CMC submissions, including BLA/MAA, INDs, CTAs/IMPDs, briefing documents, and responses to queries.

Minimum of 10 years of pharmaceutical/biotech experience, including five years of Global Regulatory Affairs (CMC) experience.

Experience as a RA CMC product lead.

Experience in Cell or Gene Therapy.

-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.

Skilled in the use of clinical trials and electronic document management systems

Assure the proper management, retention, and version control of all applicable regulatory documentation including master files and amendments.

Assist with sponsor monitoring visits remotely and onsite as needed.

Perform other responsibilities as assigned.

Bachelor’s Degree in a related field or equivalent experience

Knowledge of US FDA regulations and guidelines that govern clinical research (GCP/ICH and IRB)

2) Appropriate full-time work experience is mandatory (no students or fresh graduates please)

3) Recent experience in the nutraceuticals industry is strongly preferred

4) Preference will be given to candidates with recent experience in regulatory affairs

4) Help the Regulatory Affairs Team apply complex regulatory concepts to projects in an easy-to-understand manner

5) Understand the interrelationship between labeling, artwork, and product regulations

8) Maintain regulatory records and files

Science (biology, chemistry etc.) preferred. (Or Equivalency, special qualifications, certifications, licenses, etc.)

Specific Responsibilities Receive documents from various sources and review for completeness and suitability for submission to FDA.

Review regulatory documents to assure FDA requirements are met and are ready for submission

With the manager's guidance, prepares new IND, NDA and SNDA submissions, amendments and supplements.

Needs to be able to organize and prioritize tasks and work independent of manager.

With more complex tasks/submissions, work with the manager to accomplish goals/tasks.

5-7 years of experience in regulatory affairs, policy, trade compliance, strategy or business development in the power market industry

Experience in PJM, MISO or NYISO power markets

Experience in managing external consultants and deriving/approving external scopes of work

Experience representing power generation in ISO/RTOs

Extensive work experience beyond the 5-year minimum.

Lead ISO/RTO Regulatory Affairs Activities for FERC jurisdictional electricity markets, including formulation of internal policy goals and external representation

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;

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.

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

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.

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)