Regulatory Affairs Operations Associate Jobs in Union, Arkansas

Excellent project management skills. Must be incredibly efficient while also exercising judgment in allocating limited resources.

1-2 years experience in the energy sector preferred, with some working knowledge of the wholesale markets.

Master our business by working across the organization (Operations, Energy Markets, Engineering) and use that knowledge in advocacy.

Excellent written and verbal communication skills, effectively distilling complex ideas. Comfortable with basic data analysis.

Graduate degree (e.g., J.D. or Masters Degree) strongly preferred, or equivalent experience, with 0-2 years of post-degree work experience.

Work with cross-functional teams, especially Energy Markets, to develop these communications.

Project management and process improvement experience

Proficiency in designing and improving workflows, and demonstrative project management experience.

5+ years of healthcare industry regulatory analysis experience, in the health plan/managed care space.

Project manage the internal tracking and monitoring of Regulatory Operations team deliverables related to our Legislative processes.

A bachelor's degree in a legal, healthcare-related or humanities field, or 4 years commensurate experience.

Be the EOC SME for the regulatory operations ecosystem and current strengths, weaknesses, and gaps within important region(s)

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.

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 .

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

• Administrative and project management skills

What are your top three to five technical skill requirements?

• Maintain awareness of regulatory requirements and ensure continued learning

• Maintain regulatory files in a format consistent with requirements

• Interpersonal and communication skills

• Technical system skills (e.g. word processing, spreadsheets, databases, online research)

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.

Experience with vendor and supplier management and engagement

Experience with contract management systems for legal agreements and contracts

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

Bachelor's Degree in Business Administration, Economics, or related field preferred or a combination of education and experience.

Experience working in a fast-paced remote environment preferred as well as experience working with highly matrixed global organizations

A minimum of 3 years' experience in clinical regulatory affairs highly preferred.

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.

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)

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)

Regulatory experience in the cosmetic industry, with a particular focus of EU fragrance allergens is a plus.

IT Skills (Microsoft Office, SAP, etc.)

Analytical skills and understanding technical scientific information

Strong written and oral communication skills are required. Strong interpersonal skills are important for working in fast-paced and matrix driven environment

Gathering, generating, and managing technical fragrance information

Provide Regulatory guidance, and support, including but not limited to:

Skills: Knowledge of US and/or Canadian regulation relating to product and/or device clearance

Communicates issues to management through project management tracking and issue briefings.

Minimum of 3 years’ experience

Ability to manage and track broad and strategic projects.

Responsible for effective communication of regulatory requirements to project teams and internal customers.

Position is highly visible to internal and external stakeholders.

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.

• Serves system administrator for the client's US Regulatory electronic document management system

Location: Deerfield IL Or 100% Remote

Job Title: Publishers (US Submissions)

Pay Range: $25.00/hr to $30.00/hr on W2

• He/she will serve as the primary publisher of US Regulatory submissions (Drug and Device)

7. Report protocol deviations and serious adverse events to the IRB according to protocol and IRB requirements.

2. Exceptional planning/organizational skills and attention to detail.

3. Strong verbal and written communication skills.

1. 1 year of clinical research experience preferred.

1. Prepare regulatory documents for new study submissions to the IRB and sponsor.

Track the status of new submissions and inform clinical operations of relevant updates for study activation planning.

2+ years of experience in a clinical research environment.

Perform initial and subsequent IRB submissions.

Create and maintain the Investigator Site File for all studies awarded to Pharmaron CPC.

Generate all essential documents (i.e., Form FDA 1572, Financial Disclosure Forms, etc.) for submission to sponsor.

Report deviations/violations and Serious Adverse Events to the IRB.

Ensure IND safety reports are submitted to the PI and IRB for review.