Top 76 Holistic wellness Jobs in Grand Rapids, Mi

Regulatory Affairs Professional/Sr. Regulatory Affairs Professional
Grand River Aseptic Manufacturing, Inc. —Grand Rapids, MI
- Full-time
- 6 years
- Bachelor's degree
- Senior level
- Paid holidays
- Health insurance
Quick Apply
Licensed Practical Nurse (LPN)
The Oaks at Belmont —Belmont, MI
- $28.39 - $37.06 an hour
- Full-time
- CPR Certification
- Management
- BLS Certification
- Paid parental leave
- Health savings account
HR Administrator
Trane Technologies —Grand Rapids, MI
- $25.77 - $30.43 an hour
- Overtime
- Microsoft Word
- Microsoft Excel
- Microsoft Access
- Paid holidays
- Health insurance
1d
Order Management Representative
Trane Technologies —Grand Rapids, MI
- $29.90 an hour
- Full-time
- Microsoft Excel
- Microsoft Outlook
- Pass drug screening
- Paid holidays
- Health insurance
1d
Host
BJ's Restaurants —Grand Rapids, MI
- $14 - $16 an hour
- Part-time
- 18 years or older
- Restaurant
- Entry level
- Health insurance
- Dental insurance
Patient Coordinator
AlignWell Chiropractic —Holland, MI
- $18 - $20 an hour
- Part-time
- Hospitality
- Spanish
- Google Workspace
- Health insurance
- Paid time off
Quick Apply
6d
Dishwasher
BJ's Restaurants —Grand Rapids, MI
- $16 - $18 an hour
- Part-time
- Hospitality
- 18 years or older
- Entry level
- Health insurance
- Dental insurance
Janitorial
BJ's Restaurants —Grand Rapids, MI
- $18 - $20 an hour
- Part-time
- In person
- Hospitality
- 18 years or older
- Sanitation
- Health insurance
- Dental insurance
Take Out
BJ's Restaurants —Grand Rapids, MI
- $14 - $16 an hour
- Part-time
- 18 years or older
- Communication skills
- Entry level
- Health insurance
- Dental insurance
Server
BJ's Restaurants —Grand Rapids, MI
- $5.49 an hour + tips
- Part-time
- Casual dining restaurant
- Mid-level
- 21 years or older
- Health insurance
- Dental insurance
Contracting Project Administrator
Trane Technologies —Grand Rapids, MI
- $48,101.66 - $67,689.99 a year
- Overtime
- Pass drug screening
- Mid-level
- Office
- Paid holidays
- Health insurance
Material Handler 1st Shift
Trane Technologies —Grand Rapids, MI
- $20 an hour
- Full-time
- Computer literacy
- Pass drug screening
- English
- Paid holidays
- Health insurance
Project Manager
Granger Construction —Grand Rapids, MI
- Full-time
- Mid-level
- Bachelor's degree
- Experience equivalent to degree accepted
- Health insurance
- Paid time off
Material Handler 2nd Shift
Trane Technologies —Grand Rapids, MI
- $22 an hour
- Full-time
- Computer literacy
- Pass drug screening
- English
- Paid holidays
- Health insurance
Massage Therapist - Campus Health Center (Temporary)
Grand Valley State University —Allendale, MI
- $34 an hour
- Part-time
- CPR Certification
- Mid-level
- University
Team Lead 1st Shift - P5
Trane Technologies —Kentwood, MI
- $27.71 an hour
- Overtime
- Basic math
- Pass drug screening
- Mid-level
- Paid holidays
- Health insurance
6d
Sales Enablement Administrator
Trane Technologies —Grand Rapids, MI
- $24.76 an hour
- Full-time
- Microsoft Outlook
- Engineering
- Pass drug screening
- Health savings account
- Paid holidays
Occupational Health Nurse
Trane Technologies —Grand Rapids, MI
- $56,300.00 - $101,394.99 a year
- Full-time
- CPR Certification
- Nursing
- RN License
- Paid holidays
- Health insurance
Busser
BJ's Restaurants —Grand Rapids, MI
- $10 - $12 an hour
- Part-time
- 18 years or older
- Guest services
- Restaurant
- Health insurance
- Dental insurance
Shipping Team Lead
Trane Technologies —Grand Rapids, MI
- $27.71 an hour
- Overtime
- Pass drug screening
- Mid-level
- CDL
- Paid holidays
- Health insurance
7d

I want to receive the latest job alert for holistic wellness in grand rapids, mi

By signing in to your account, you agree to SimplyHired's Terms of Service and consent to our Cookie and Privacy Policy.

Explore jobs in more locations

holistic wellness jobs near grand rapids, mi

Regulatory Affairs Professional/Sr. Regulatory Affairs Professional

Grand River Aseptic Manufacturing, Inc. -
Grand Rapids, MI

Quick Apply

Job Details

Full-time

Benefits

Paid holidays
Health insurance
Dental insurance
Paid time off
Vision insurance
Benefits from day one
Life insurance

Qualifications

FDA submissions
USP standards
Content creation for technical audiences
Technical writing experience within manufacturing
FDA 21 CFR Part 11
Investigational new drug (IND) applications
ICH guidelines
Bachelor's degree
Pharmaceutical company experience
Biomedical regulatory compliance
Pharmaceutical manufacturing facility experience

Full Job Description

Agility, Impact, Methodology. Do you exhibit these values and wish to be around others that do too? Do you thrive in fast-paced environments where agility, adaptability, and high standards go hand in hand? Are you driven to make a meaningful impact, whether through your work, your support of others, or your commitment to your community? Are you motivated by a disciplined, science-based approach that ensures consistent excellence, safety, and integrity in everything you do? If these statements resonate with you, Grand River Aseptic Manufacturing (GRAM) welcomes you to apply to join our community of dedicated individuals improving lives every day!

Overview of this Position:

The Regulatory Affairs Specialist oversees regulatory affairs activities for the contract development and manufacturing organization (CDMO) where GRAM’s clients are the sponsors, application- and license- holders for sterile injectable products, from clinical through commercial phases. Manages a broad spectrum of projects to support the regulatory needs of GRAM and GRAM’s clients. This position interacts with all internal departments within GRAM and with external clients, suppliers, contractors, and regulatory agencies. This position does not oversee direct reports. This is not a remote role.

Non-Negotiable Requirements:

Bachelor’s degree in Life Sciences or a related field
10+ years of experience in the pharmaceutical industry and 6 years of hands-on experience in Regulatory Affairs with increasing responsibilities.
Working knowledge of regulatory requirements (e.g., FDA/ICH/EUGMP regulations, GDUFA) and familiarity with regulatory submissions for INDs, ANDAs, NDAs, DMFs, CRL/DRL/IR ANDA,EU variation review responses, post-approval supplements and pre-submission meeting packages.
Knowledgeable in regulatory science and submission data requirements of all phases of product development for sterile parenteral products.
Knowledge of cGMP, ICH, and USP regulations or guidelines.
Excellent technical writing skills.
Prior experience preparing FDA correspondence.

Preferred Requirements:

Candidate with prior or current roles within or working closely with a CMO/CDMO preferred.
Experience with international pharmaceutical regulations desired (TGA, ANVISA, JP, EMA, Health Canada, etc.).
Regulatory Affairs Certification (RAC).
Member of pharmaceutical trade associations such as RAPS, ISPE, PDA, etc.
Advanced knowledge of quality standards (FDA 21 CFR 11, 210, 211, 600; EudraLex vol 4, Annex 1, PIC/S) statistical analysis, root cause analysis, quality measurement, CAPA, SPC, FMEA.

Responsibilities Include (but are not limited to):

Maintain current knowledge of all relevant regulations (21CFR Parts 11, 210, 211, 600, 820 and applicable guidance documents, EudraLex Volume 4) while also monitoring any changes that occur which may impact products manufactured as well as access and communicate regulatory requirements to stakeholders in order to maintain compliance without delay to business due to regulatory issues.
Provide regulatory CMC support to GRAM clients, including providing documents for filings and review of client submissions on behalf of GRAM; ensure submissions are aligned with GRAM’s supply agreements (e.g. clinical, commercial, markets).
Submit and maintain letters of authorizations (LOA) for GRAM’s clients to reference a Type V Drug Master File in submissions.
Maintain and manage existing FDA establishment registrations and product listings (NDC, SPL), filing/obtaining new registrations as required.
Generate and maintain NDC codes for GRAM’s FDA approved commercial products for Cares Act Reporting.
Facilitate GRAM Client quality agreements, providing input and ensuring alignment with regulatory requirements.
Responsible for submitting annual GDUFA self-identification(s) to FDA.
Maintenance of GRAM’s Type V Drug Master File (sterile processing facility), including amendments, annual reports.
Maintenance of Site Master Files for GRAM’s facilities.
Support BD due-diligence evaluation of new business opportunities and provide meaningful contributions to the new-business selection process.
Develop and maintain SOPs, work instructions, forms and other documentation and training materials related to Regulatory Affairs.
Perform Regulatory Assessments for GRAM’s holistic change control process.
Write, revise, review relevant departmental SOPs, SWIs and associated documents.
Support Agency, customer and vendor audits as needed.

Full job description available during formal interview process.

What Sets GRAM Apart from Other Employers:

MEDICAL BENEFITS starting day 1: Medical, prescription, dental, vision, life insurance, and disability benefits are available to you and your family on your first day of work, with the company paying a portion of the cost! Once eligible for the 401(k) program, all your contributions are immediately 100% vested, and you are immediately vested in GRAM contributions as well. We also offer generous off-shift premiums!

Paid VOLUNTEERISM starting day 1: GRAM encourages giving back to our community by offering 16 hours of paid volunteer time per calendar year!

PTO: Full-time employees accrue up to 13 days of time off per calendar year. You choose how to use this time for your vacation, sick, or mental health needs!

WELLNESS TIME OFF: Employees earn 1 hour of time off for every 30 hours worked to use how you choose.

PAID HOLIDAYS: We offer 10 paid holidays per calendar year with immediate eligibility!

PAY: Depends on Experience and is discussed during the interview process.

If you meet the required criteria listed above, GRAM welcomes you to apply today!

Quick Apply

Refine Your Search

holistic wellness jobs in grand rapids, mi

Regulatory Affairs Professional/Sr. Regulatory Affairs Professional

Licensed Practical Nurse (LPN)

HR Administrator

Order Management Representative

Host

Patient Coordinator

Dishwasher

Janitorial

Take Out

Server

Contracting Project Administrator

Material Handler 1st Shift

Project Manager

Material Handler 2nd Shift

Massage Therapist - Campus Health Center (Temporary)

Team Lead 1st Shift - P5

Sales Enablement Administrator

Occupational Health Nurse

Busser

Shipping Team Lead

I want to receive the latest job alert for holistic wellness in grand rapids, mi

Related Searches

Explore jobs in more locations

Job Seeker Tools

Employer Tools

Browse

Stay Connected