Regulatory Affairs Operations Associate Jobs

Detail-oriented with good organization and time management skills.

Make decisions related to work processes or operational plans and schedules in order to achieve program objectives established by senior management.

Develops regulatory processes and procedures aligned with global regulatory requirements and train key personnel in accordance with these processes and procedures.

Develops and maintains product labeling (e.g. technical information summaries, instructions for use etc.), advises team on labeling requirements.

Utilize technical regulatory skills to propose strategies on complex issues.

Determine submission and approval requirements.

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

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.

EDUCATION AND EXPERIENCE YOU’LL BRING

Strong organizational and follow-up skills, as well as attention to detail.

Experience writing clear and concise technical documents.

Conducts reviews of product and manufacturing changes for compliance with applicable regulations.

May interface directly with FDA and other regulatory agencies.

Work with cross-functional team to support product release process.

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 .

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.

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.

Provide leadership to maintain compliance with domestic and international regulations as well as management of the Avanos Mexico facilities’ State Licenses.

Continue to increase education/knowledge in the area of Regulatory Affairs.

Making a difference in our products, services and offers, never ceasing to fight for groundbreaking solutions in everything we do;

Eight to ten years experience in Regulatory Affairs.

Exceptional written and verbal communication skills.

Team player with excellent organizational skills.

Management Strong management with depth of experience working for global health authorities.

Experience with project lifecycle and management

Strong management with depth of experience working for global health authorities.

Interacts with the assigned Project Assistant (PA) to ensure accurate financial management and for general project support.

Interacts professionally at multiple levels including senior management within a client organization.

Successfully penetrates executive management levels or other business units within a client organization.

NOTE: Higher education may compensate for years of experience. Years of experience may also compensate for lower education

Liaises with vendors to communicate and coordinate legalization of documents in accordance with country requirements.

Receives projects from manager but has responsibility for managing own projects with oversights

Reviews project progress with manager on a regular basis and escalates issues

Required Education: Bachelor’s Degree in life sciences

Required Experience: 2 years pharmaceutical or industry related experience

NOTE: Higher education may compensate for years of experience. Years of experience may also compensate for lower education

Liaises with vendors to communicate and coordinate legalization of documents in accordance with country requirements.

Receives projects from manager but has responsibility for managing own projects with oversights

Reviews project progress with manager on a regular basis and escalates issues

Required Education: Bachelor’s Degree in life sciences

Required Experience: 2 years pharmaceutical or industry related experience

Bachelor’s degree with a strong academic record. Relevant internship or professional (e.g., public policy, economics, finance) experience.

We are proud to offer the following featured benefits

Excellent communication, both written and oral, and analytical skills.

FSA and Commuter benefit programs

Working with members of the ISS Regulatory Affairs team and internal stakeholders to identify policy risks and opportunities.

Tracking, synthesizing, and summarizing legislative and regulatory developments and proceedings, including for non-technical audiences.

Proven organized and solid time management skills

2+ years of direct Medicaid and Medicare pharmacy licensing/enrollment experience

Experience with interacting and collaborating with a variety of stakeholders and in a team setting

Ability to comprehend state and federal requirements and regulations

Experience in a pharmacy or clinical setting

Proven solid problem solving and analytical skills

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

Communicates cross-functionally and cross-company as well and presents CMC management-approved regulatory strategy and opinion to project teams is required.

Works with other CMC RA personnel to assure compliance with local regulatory requirements and commitments per the GRT.

Prior drug development, analytical development, or manufacturing experience is required.

Demonstrated ability to communicate regulatory requirements is required.

Good verbal and written communication skills, good organizational skills and strong attention to detail is required.

Working knowledge of global HA laws, regulations, and guidances is required.

Strong time management skills with ability to effectively prioritize tasks

Updating internal project trackers and project management systems

Strong written and verbal communication skills

Assist with day-to-day regulatory operations (formula review, filings, formula testing, sample shipping, document organization, etc.)

Help collect formulas and documents from manufacturers to support the product safety and regulatory review process

Assist with international product registrations and global compliance reviews

Years Experience: 1+ years experience in a medical device or similarly regulated industry

Skills: Ability to schedule and organize multiple projects

Education: BS Engineering or Scientific

Duties: Manager regulatory submissions to ensure timely regulatory approval of medical devices.

Monitor changing regulations in geographies and translate/communicate these requirements to project development and/or continuous improvement project teams.

Ensure all client products and procedures comply with applicable regulatory agency requirements and guidelines.

Rate $40-45 an hour depending on experience.

100% remote – CST hours preferred.

A bachelor’s degree in a life science discipline and 3+ years of relevant regulatory experience, including FDA and Health Canada regulations.

Regulatory experiences on Class I Medical Device or Consumer Products or Cosmetic Products.

Provide regulatory support on Labeling and Ad Promo (Artwork/copy doc.) reviews and approvals.

Provide regulatory support with procedures/SOP development and continuous improvements.

KEY SUCCESS FACTORS: EDUCATION, EXPERIENCE, KNOWLEDGE AND SKILLS

• Manage the application and communication of all *** policies, procedures, and *** Way of Management.

• Effective personal time management.

LOCATION: Can be 100% Remote (or Hybrid/Plainsboro, NJ)

• Experience with submission work in VaultRim

• Experience with RA compliance reports including (NDA, BLA, ODD, DSUR, PBRER

Gain working knowledge of North American cosmetic regulations and product claims substantiation as part of the North America regulatory team

Strong organizational skills with the ability to meet project deadlines

Prepare and submit product notification/registration and updates ensuring accuracy, completeness, and timeliness

Track and maintain accurate records of submissions

Help update and maintain product master database

Provide support with products survey reporting as needed