Regulatory Affairs Jobs in Arkansas

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;

At least 15 years of Global Regulatory Affairs leadership experience.

Extensive knowledge of ICH, FDA, EMA, HSA, PMDA, MFDS, and international regulations/guidelines.

Provide global regulatory leadership supporting global development.

Proactively participate in the design of US and ex-US regulatory strategies for the development of precision oncology therapies.

Direct and negotiate submissions (IND, CTA, NDA, MAA etc..) and approvals with regulatory authorities.

Form partnerships across the Science Units to provide/facilitate provisions of the appropriate regulatory affairs advice to each area.

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;

Excellent interpersonal skills and experience working with different personalities, cultures and levels of management.

Many years in complex projects or programs including first experience in portfolio management.

Strong analytical, multitasking, time management, and organizational skills with focused attention on detail.

Strong knowledge of project management concepts, tools, templates and methodologies and when to employ them.

Experienced in strategic planning and risk management.

MS Project and project management tools.

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

Maintaining a working knowledge and thorough understanding of federal and institutional regulations and polices relating to human subjects research

2+ years of experience in clinical research

Experience using electronic regulatory platforms a plus

Experience with industry-sponsored clinical trials preferred

Conducting internal auditing and monitoring activities to ensure compliance with study protocols and applicable regulations

Assisting investigators and clinical research coordinators in preparing for site monitoring visits and audits

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.

Experienced financial management including budgets, forecasting, recoverability

Experience managing a variety of medical communications tactics

Manages resourcing needs across the team in conjunction with the VPs

Manages and inputs into the career development of direct reports and their teams, closely reviewing goals and objectives

Line manages multiple team members of varying levels, providing constructive and actionable feedback to team members

Extensive experience working within regulatory affairs and/or the medical communications industry

· 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

7-10+ years Regulatory Affairs experience

Experience in development and commercial product lifecycle (Phases 1-3, Marketed Products)

Relevant experience with regulatory applications (IND / CTA / NDA / MAA etc.)

Success in filing IND's/CTA's in Oncology

Educated (MSc, PhD, or PharmD) in the Life Science, Pharmacy or similar field.

Direct exposure to FDA/EMA etc. Interactions

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.

May participate in continuous improvement activities related to role including supplier payment management, external agreement process, etc.

Maintains organizational charts for both departments and maintain email distribution lists.

Supports expense reporting for leadership in GRA and GCA.

Experience with documentation and lifecycle management within the biotechnology industry preferred

Effectively communicate the regulatory strategy, risks mitigation, and overall plans to program teams and senior management

Knowledge of regulatory requirements across development stages

Manage filings of necessary regulatory documents and manage lead meetings with regulatory agencies and other reviewing bodies

Identify applicable regulatory requirements for conducting clinical trials

Manage and help negotiate the regulatory activities of contract research organizations, consultants, and contractors in the preparation of regulatory submissions

Expert knowledge of regulations, and experience with interpretation and application

Strong negotiation skills and significant experience in interacting with regulatory authorities

Experience in the development and implementation of CMC regulatory strategies throughout the lifecycle of pharmaceuticals/devices

Experience in a pharmaceutical manufacturing facility/development laboratory preferred.

Exp withGlobal responsibility for regulatory submissions and registrations preferred

Risk identification in terms of CMC regulatory strategy

Bachelor’s Degree (May be substituted with paralegal certification or experience)

Review and provide interpretation of proposal requirement

Gather information regarding education laws, ordinances, and regulations

Adding new program offerings or modifying program offerings on already approved state and regional ETPL approvals

Experience as a Certified Nursing Assistant

Fully remote working environment with equipment provided by MedCerts

Strong management and leadership skills; experience leading/managing a team/project and/or supervising staff preferred.

Works closely with project management to mitigate/resolve issues and/or deviations from target timelines.

Provides regulatory and project management support for projects as needed.

Superior organizational skills and customer service abilities.

Strong working knowledge of Microsoft office; experience with SharePoint a plus.

Supervises and manage Regulatory Team staff members, as assigned.

Knowledge or experience with regulatory requirements in other regions and familiarity with GMP regulations is a plus.

In-depth knowledge of ICH requirements and regulatory requirements in the US/EU.

Proficiency in authoring complex technical documents, including CTD M2 and M3 sections, and life cycle management.

8+ years of experience in regulatory CMC within the pharmaceutical or biopharmaceutical industry.

Excellent oral and written communication skills are essential.

Detail-oriented, self-motivated, and comfortable handling broad responsibilities in an entrepreneurial, fast-paced environment.

Knowledge/experience with regulatory requirements for other regions is desirable.

Independently plan and manage regulatory activities related to assigned projects, covering areas such as clinical, non-clinical, and CMC, with minimal supervision.

Manage the preparation, review, and timely submission of regulatory dossiers required for investigation and registration of products in relevant markets.

BA/BS degree or equivalent experience in a pharmaceutical or health science field is required.

Minimum of 7 years of related experience in regulatory affairs is required.

Familiarity with CTD/eCTD and experience in publishing documents using Adobe Acrobat Professional.

Create and manage IVDR Technical Files.

It would be a plus if you also possess previous experience in: 510k author.

Work with international colleagues on establishing design dossiers for their intended market for new product development and design changes.

Subject matter expertise in registration and commercialization of medical devices.