America Medic & Science Hiring for Medical Affair Specialist – Neutraceutical Job at Woodinville, WA Full Time

JOB DESCRIPTION

America Medic & Science AMS is an American nutraceutical company established in 2007 and headquartered in Seattle, Washington. We manufacture and distribute high-quality, organic natural products and dietary supplements for all individuals and age groups.

AMS is looking for Medical Affairs Specialist who will plan, organize, and implement strategies and activities required to procure regulatory approval for new and revised product lines for the pharmaceutical and nutraceutical industry. He/she will ensure regulatory compliance to all US and International requirements, corporate policies and procedures regarding submissions, and other requirements for market approval of medical products. The Manager of Regulatory Affairs will provide greater support to the group by taking on more projects of greater complexity under minimal supervision.

The Medical Affairs Specialist is responsible for regulatory oversight of and representation for medical products, maintaining up-to-date knowledge of drug regulations and domestic and international guidance, with a special focus on international regulations.

DUTIES & RESPONSIBILITIES

• · Implement regulatory strategy for registration of company products internationally, including identification of regulatory requirements in applicable foreign countries, collecting, and generating all needed documentation, including the legalization of documentation (GMP Certificates, establishment licenses, etc.), filing and communications with foreign Health Authorities or company authorized representatives as applicable
• · Provide regulatory support on product development teams through the product life cycle on product project teams (e.g., developing regulatory strategies, timeline development, change control, and preparing submission related documents)
• · Maintain up-to-date knowledge of drug regulations and guidance, both domestic and international, with a special focus on international regulations
• · Participants in internal and external Quality System Audits.
• · Responsible for coordinating the planning, preparation, assembly, review, and publication of regulatory submissions to the FDA, and other worldwide government agencies. Ensure regulatory submissions are accurate and verifiable against source documents to confirm compliance and traceability.
• · Track and maintain regulatory registrations and product blocking lists to ensure valid international regulatory clearances, sales, and commerce implications.
• · Other duties as assigned

REQUIREMENTS

• Bachelor’s Degree in life science is required or equivalent experience and training
• 5-8 years of regulatory experience in the pharmaceutical/biotech industry.
• Strong verbal and written communication and interpersonal skills.
• Creative, flexible, and innovative team player.
• Ability to work in a fast-paced, constantly changing work environment.
• Good project management and time management skills.
• Working knowledge of US and international regulations and guidelines.
• Experience managing pharmaceutical, nutraceutical, or combination product regulatory US applications, especially post-approval supplements.
• Experience in communications with International Health Authorities desired.
• Experience with regulatory compliance of drug product promotional and labeling materials preferred.
• Experience with electronic submission filings preferred.
• Proficiency on Microsoft Office.

Job Type: Full-time

Benefits:

• Dental insurance
• Flexible schedule
• Health insurance
• Life insurance
• Paid time off
• Parental leave
• Referral program
• Tuition reimbursement
• Vision insurance

Schedule:

• 8 hour shift
• Monday to Friday

Supplemental Pay:

• Bonus pay
• Commission pay

COVID-19 considerations:
Temperature screenings
Social distancing guidelines in place
Virtual meetings
Proper and continual use of a face mask at all times in the unit. Also emphasize use of all required PPE.

Education:

• Bachelor’s (Preferred)

Work Location: One location