- Bachelor of Science degree in Nutrition, Food Science, Biology, Chemistry, or related discipline
- 0-2 years professional experience; preferably in food, beverage, or dietary supplement industry.
- Working knowledge of food and nutrition regulations for US, Canada and EU preferred.
- Strong written and verbal communication skills.
- Self-motivated with ability to drive projects with minimal guidance.
- Able to manage multiple projects and tasks.
- Ability to work under tight deadlines and changing priorities.
- Ability to follow SOPs and the know how to provide improvement recommendations of existing SOPs.
- Detail oriented with strong analytical, problem-solving, and organizational skills.
- Proficient in Microsoft Office suite. Experience with Microsoft SharePoint a plus.
- Majority of work is completed in an office setting working inside a controlled office environment. The noise level in the work environment is generally low.
- The employee will on occasions be required to enter the warehouse, lab, and/or production environment requiring the use of personal protective equipment such as safety glasses, ear plugs, hair and/or beard nets and meet other GMP policies and guidelines.
- Position requires the ability to sit for a minimum of 6 hours per day.
- Ability to stand, walk, bend over, and reach above head on a regular basis.
- Ability to lift or carry up to 20 pounds occasionally and repetitive use of hands/arms for writing, filing, and computer work.
- Ability to understand and follow GMP guidelines when in manufacturing environment area.
- Performs routine research and administrative functions to ensure company products are following US and Canadian medical food regulations and third-party certification requirements.
- Contribute to completion of routine technical tasks such as proof-reading product packaging and nutritional information.
- Work closely with product development and graphics teams to ensure technical accuracy and compliance of packaging and labelling artwork.
- Works closely with RAM to make decisions pertaining to claims, callouts, and third-party certifications.
- Assists with maintaining nutrition information for U.S. and international products, confirm appropriate calculation methods by country, verifying rounding rules, acceptable use regulations for ingredients, standards of identity.
- Review product claims and substantiation documents for compliance in the US and Canada
- Assist RAM with cross functional labelling review process.
- Assist RAM and QA team in maintaining and acquiring product certifications necessary to support the business.
- Monitor US FDA and Health Canada food and medical nutrition regulations through newsletters, government websites, and other methods
- Assist with raw material reviews for regulatory conformity based on industry guidance in the US their compatibility with FSMP regulations and other international restrictions.
- Collaborate with International RA team as necessary to provide documentation needed for international product registrations.
- Adhering to all company SOPs with regards quality and safety.
- Other duties as assigned.
-
Associate Director Regulatory Affairs Oncology
2 weeks ago
EMD Serono Billerica, United StatesWork Your Magic with us Start your next chapter and join EMD Serono. · Ready to explore, break barriers, and discover more? We know you've got big plans '" so do we Our colleagues across the globe love innovating with science and technology to enrich people's lives with our solut ...
-
Associate Director, Regulatory Affairs, Labeling
2 weeks ago
Gilead Sciences Boston, United StatesFor Current Gilead Employees and Contractors: · Please log onto your · Internal Career Site · At Gilead, we're creating a healthier world for all people. For more than 35 years, we've tackled diseases such as HIV, viral hepatitis, COVID-19 and cancer - working relentlessly to dev ...
-
Associate Director, Multicultural Affairs
2 weeks ago
InsideHigherEd Lowell, United StatesJob no: 522430 · Position type: Staff Full Time · Benefit Status: Benefited-Union · Campus: UMass Lowell · Department: Multicultural Affairs · Salary: Salary commensurate with experience and grade/range · Applications Open: Feb · Applications Close: Open until filledGeneral Summ ...
-
Regulatory Affairs Associate
3 weeks ago
WHITE COLLAR TECHNOLOGIES INC Boston, United StatesJob Description · Job DescriptionJob Description · We have multiple openings for Life Science Quality Assurance Analysts, Regulatory Affairs Specialist, and Quality Control Analysts. All of these roles will interface with clients on different projects to provide consulting servic ...
-
Associate Director, Medical Affairs
4 weeks ago
Apellis Waltham, United StatesJob Description · Job DescriptionPosition Summary: · The Associate Director, Ophthalmology is a key member of the Global Medical Affairs team who will work closely with medical affairs and cross-functional stakeholders to implement key aspects of the Global Medical strategy for o ...
-
Associate Director, US Medical Affairs
1 week ago
Apellis Pharmaceuticals Waltham, United StatesPosition Summary: · The Associate Director of Medical Affairs, Ophthalmology is a key member of the medical affairs team who will work closely with medical affairs and cross-functional stakeholders to implement key aspects of the US strategy for ophthalmology and pegcetacoplan f ...
-
Proclinical Staffing Cambridge, United StatesAssociate Director, US Regulatory Affairs, Advertising & Promotion - Permanent - NJ & MA · Proclinical is seeking an Associate Director, US Regulatory Affairs, Advertising & Promotion for a large global pharmaceutical company with locations in New Jersey and Massachusetts. · Pr ...
-
Associate Director, Medical Affairs
4 weeks ago
Apellis Pharmaceuticals, Inc. Waltham, United StatesPosition Summary: · The Associate Director, Ophthalmology is a key member of the Global Medical Affairs team who will work closely with medical affairs and cross-functional stakeholders to implement key aspects of the Global Medical strategy for ophthalmology and potential global ...
-
Associate Director, Multicultural Affairs
3 weeks ago
UMass Lowell Lowell, United StatesGeneral Summary of Position: · The Office of Multicultural Affairs (OMA) is the hub for intercultural advancement, diversity, community development, and inclusion efforts at the University of Massachusetts Lowell. The office serves as a resource on topics related to diversity, eq ...
-
InsideHigherEd Boston, United States Administrative Jobs ,DIRECTOR OF GRADUATE STUDENT SUPPORT, Associate Provost for Graduate Affairs Tracking Code Job DescriptionThe Director of Graduate Student Support is a leader in Graduate Affairs, responsible for developing and maintaining University-wide partnerships, overseeing strategic projec ...
-
Associate Director of Regulatory Affairs
2 days ago
PSG Global Solutions Careers Cambridge, United StatesApply now and our proprietary system will quickly have you in front of a live recruiter. · The Opportunity · Description · We're looking for an Associate Director of Regulatory Affairs, working in Pharmaceuticals and Medical Products industry in Cambridge, Massachusetts, Unite ...
-
Associate Director Regulatory Affairs
3 weeks ago
Sherlock Biosciences Watertown, United StatesJob Description · Job DescriptionSalary: · Overview · Sherlock Biosciences is dedicated to providing global access to the simplest and most accurate diagnostic tests that empower individuals to control their own healthcare. We are creating a new generation of CRISPR and Syntheti ...
-
Fresenius Medical Care North America Watertown, United StatesThis position can be fully remote · Global Regulatory experience needed. · Demonstrated project management experience needed. · PURPOSE AND SCOPE: · Ensures company products meet regulatory requirements by supporting all assigned regulatory aspects of product approval and pos ...
-
Remote - Regulatory Affairs Associate II Pharma
7 hours ago
Fresenius Medical Care North America Watertown, United StatesThe ideal candidate should have US Advertising and Promotion experience. · This position can be fully remote. · PURPOSE AND SCOPE: · Ensures company products meet regulatory requirements by supporting all assigned regulatory aspects of product approval and post-marketing compl ...
-
Associate Director, Regulatory Affairs
3 weeks ago
Relay Therapeutics Cambridge, United StatesThe Opportunity: · We are looking for a strategic regulatory leader to join our growing regulatory team at Relay Tx. You will have the opportunity to define and implement innovative regulatory strategies to expedite the development and approval of our transformative pipeline. Yo ...
-
Ipsen Pharma Cambridge, United StatesTitle: · Associate Director, Medical Affairs, Adult Cholestatic Diseases · Company: · Ipsen Biopharmaceuticals Inc. · Job Description: · Associate Director, Medical Affairs, Adult Cholestatic Diseases · Summary / purpose of the position · Reporting to the Director, Medical A ...
-
Regulatory Affairs Senior Associate
4 days ago
The Judge Group Inc. Boston, United StatesLocation: REMOTE · Salary: $30.00 USD Hourly - $37.00 USD Hourly · Description: Our client is currently seeking a Regulatory Affairs Senior Associate · Day to Day Responsibilities:Support the implementation of Veeva Vault, IDMP, EU CTR, and other regulatory initiatives. · Wor ...
-
Biogen Cambridge, MA, United StatesThe Associate Medical Director - Alzheimer's role is a part of US Medical, a strategic partner within Biogen, that helps inform medical practice across our therapeutic areas and pipeline to improve meaningful patient outcomes. As a key member of the US Specialty Care Medical Dire ...
-
Biogen Cambridge, MA, United StatesJob Description · About this role · The Associate Medical Director - Alzheimer's role is a part of US Medical, a strategic partner within Biogen, that helps inform medical practice across our therapeutic areas and pipeline to improve meaningful patient outcomes. As a key member ...
-
Associate Director, US Medical Affairs
2 weeks ago
Apellis Watertown, United StatesPosition Summary: · The Associate Director of Medical Affairs, Ophthalmology is a key member of the medical affairs team who will work closely with medical affairs and cross-functional stakeholders to implement key aspects of the US strategy for ophthalmology and pegcetacoplan f ...
Regulatory Affairs Associate - Ayer, United States - Ajinomoto Health & Nutrition North America, Inc.
Description
About Us:
Eat Well, Live Well. At Ajinomoto Cambrooke, we build careers grounded in helping improve peoples health through nutritional therapies.
Ajinomoto Cambrooke (ACI) was founded by parents looking to develop better solutions for their children with PKU. Over the subsequent 20+ years, we have expanded into additional therapeutic areas with a focus on enjoyable nutrition as a core part of normalizing the life for people living with medical conditions.
Joining ACI means becoming part of a diverse team of talented people who want to build their careers while contributing back to society in a positive way. We seek individuals who bring an entrepreneurial mindset with a bias for action and finding solutions. We provide an environment based in mutual respect and collaboration to support you and give you opportunities to learn and develop.
Join us to find a rewarding work experience that lets you be at your best and have an impact on our patient communities.
Overview:The Regulatory Affairs Associate is a key contributor to the regulatory affairs team at Ajinomoto Cambrooke, Inc. This position is responsible for assisting the Regulatory Affairs Manager (RAM) with research, review and approval of product packaging and labelling materials. The Regulatory Affairs Associate will work on ensuring product formulations and claims are compliant with US FDA, Health Canada, and EU Food for special medical purpose (FSMP) regulations as well as Ajinomoto quality guidance.
Qualifications:EDUCATION, CERTIFICATIONS AND EXPERIENCE:
KNOWLEDGE, SKILLS, AND ABILITIES:
WORKING CONDITIONS:
PHYSICAL REQUIREMENTS:
Ajinomoto Cambrooke, Inc. is an Equal Opportunity Employer-Vets/Disabled, committed to a diverse workforce. If you need assistance with completion of an application for employment, please contact Human Resources Department at
