Regulatory Affairs Internship Jobs in Union, 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;

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

· 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

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

In-depth knowledge of relevant national and international regulatory requirements, guidelines, and standards, such as FDA, EMA, ISO, etc.

Proficient in using regulatory databases, document management systems, and other relevant software tools.

Familiarity with quality management systems (QMS) and regulatory compliance auditing is a plus.

Coordinate and manage regulatory submissions, including applications, registrations, notifications, and reports, ensuring completeness, accuracy, and adherence to specified timelines.

Conduct thorough research and analysis of regulatory requirements, guidelines, and industry best practices as needed – to ensure regulatory compliance.

Keep abreast of changes in regulatory requirements and communicate updates and potential impacts to relevant departments within the organization.

Conduct cost/benefit/risk analyses and recommend options or proactive solutions to assure regulatory compliance of ChromaDex

Excellent oral and written communication skills

Excellent organizational skills and ability to multitask

Whip smart - we’re looking for candidates with a keen intellect who quickly learn what they don’t know

Adaptable – Able to apply yourself on a wide variety of tasks on a daily basis

Analytical - Can assess and leverage systems and processes to figure out more effective ways to get things done

In coordination with functional groups, manage policy and filing priorities.

Able to manage consultants to assist where necessary.

Experience in the renewable energy sector.

Strong experience in the regulatory process at state and federal level with a proven track record.

Exceptional analytical skills in understanding policy impacts to energy development and pricing.

Advanced level of education in policy is preferred but not required.

•Strong leadership qualities including strategic thinking, innovation, people management, project management and excellence in communication

Position - Senior Manager (SM) Regulatory Affairs CMC (Small molecules)

•Manage post approval changes where needed

Qualifications we seek in you!

•Prior experience in big (or mid-size) Pharma companies

•Robust communication and presentation skills

· Effective time management & project planning skills.

· Must have knowledge of U.S and European product submission and registration requirements.

· Ability to work independently, taking ownership of the management of processes, projects, and timelines.

· This is a remote position; the ideal candidate will work from home.

Permanent review of the labels in order to make them compliant with new regulatory requirements and chemical/physical parameters;

· 5 to 8 years hands-on submission experience including the developing and execution of regulatory strategies.

Possible expansion to assist with pre-market management of one or more product lines

You have a BS degree with 0 - 2 years of experience working with Regulatory and Compliance data

You have strong computer skills, including the MS Office suite, and have an aptitude to learn M3, or other ERP systems

You have a strong commitment to integrity, ethical business conduct, and legal compliance.

You’re familiar with researching legislation and regulatory guidance

You’re adept at managing sensitive and confidential information, and are able to balance multiple priorities and assignments when needed

Bachelor's degree in scientific discipline or equivalent experience

5+ years' working experience in pesticide regulatory experience

Experience with registrations with US EPA and/or other regulatory authorities

Knowledge of EPA regulatory process – specifically, FIFRA 40 CFR part 158

Regulatory Manager for crop protection products (North America)

Overseeing regulatory activities and submissions for crop protection chemicals

100% remote must be okay work PST hours.

1-2+ years of Regulatory affairs medical device experience (Must be post grad experience)

Global APAC regulatory submission (Japan /China experience) required

Post grad experience with regulatory submissions

Experience with IVDs is preferred

Responsible for filing necessary applications and handling all government interactions pertaining to the regulation process for products requiring governmental approval.

Provides input to the Quality Education Unit to design Regulatory Specialist trainings and continuing education.

Explains regulations, policies and procedures to guide others on regulatory and compliance matters.

Assesses regulatory activities program wide and identify areas for improvement or that require correction and provides recommendations, as needed.

Initiates preparation for interim monitoring visits, internal audits and external audits/inspections for highly complex clinical research studies.

Monitors, interprets, applies, and communicates new and revised federal and state regulations, and local/institutional policies and guidance.

Maintains established departmental policies and procedures, objectives, quality assurance programs, safety, and compliance standards.

Manage submission plans and timelines to ensure approvals are timely and development objectives are met .

Manage regulatory data and information within systems .

Strong scientific background with at least five (5) years of experience in Regulatory Affairs in the biotechnology or pharmaceutical industries.

Proven ability to successfully manage major submissions and critical projects to deadlines.

Basic knowledge of common data processing software (EXCEL, PowerPoint, Microsoft Word, Business Objects).

Represent and coordinate regulatory information as a team member, covering clinical, non-clinical, CMC, labeling, and post-approval change activities .

Participates with senior management to establish strategic plans and objectives.

Interacts with senior management, executives, and/or major customers which frequently involves negotiating matters of significance to the organization.

Directs the activities of a functional area or multiple integrated departments through lower management.

Ensures budgets and schedules meet corporate requirements.

Agenus is Delighted to Provide you With a Comprehensive Benefits Plan, Including Some of the Following:

Makes final decisions on implementation and ensures operational effectiveness.