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Bactolac Pharmaceutical Inc
Hauppauge, NY | Full Time
$70k-91k (estimate)
2 Weeks Ago
Regulatory Affairs Associate
$70k-91k (estimate)
Full Time | Pharmaceutical 2 Weeks Ago
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Bactolac Pharmaceutical Inc is Hiring a Regulatory Affairs Associate Near Hauppauge, NY

Job Summary: Coordinate and document internal regulatory processes, such as internal audits, inspections, license renewals or registrations. May compile and prepare materials for submission to regulatory agencies.

Duties and Responsibilities

Position responsibilities may vary dependent on specific personnel and training completed.

  • Assessment of formulas, claims, and labeling to ensure compliance with domestic and international laws and regulations.
  • Prepare domestic and international documentation to support clients with registration submissions or premarket clearance.
  • Prepare and keep current domestic and international facility registrations.
  • Stay up-to-date of regulatory changes in the U.S. and foreign countries and ensure appropriate personnel are updated on such changes.
  • Create supplement facts panel, review, and approve product labels.
  • Responsible for domestic product certifications (e.g., organic, non-GMO, kosher, halal, etc.)
  • Work collaboratively with appropriate company personnel to identify regulatory requirements for products and labels.
  • Provide regulatory support and advice for clients in response to questions.
  • Uphold and enforce company’s quality policies, assist in performing internal, customer, and regulatory audits.
  • Ensure compliance to relevant regulations and standards by evaluating and addressing product/process changes and deviations
  • Review and write documentation including Standard Operating Procedures and product specifications
  • Assist with other clerical, administrative, or assigned duties as required.

Qualifications

  • Education: BS degree in Regulatory, Food Science, Nutrition, or related discipline or 1-3 years of experience in the technical aspects of food labeling, dietary supplement labeling, or Quality Assurance.
  • Training: Must satisfactorily complete all in-house training
  • Experience: Not required if employee has science background
  • Other: Strong oral, written, organizational, and critical thinking skills. Basic computer literacy. Ability to effectively prioritize and complete multiple tasks in an efficient and timely manner.

Job Type: Full-time

Pay: From $62,400.00 per year

Education:

  • Bachelor's (Preferred)

Experience:

  • relevant: 1 year (Preferred)

Ability to Commute:

  • Hauppauge, NY 11788 (Required)

Work Location: In person

Job Summary

JOB TYPE

Full Time

INDUSTRY

Pharmaceutical

SALARY

$70k-91k (estimate)

POST DATE

05/16/2024

EXPIRATION DATE

05/20/2024

WEBSITE

bactolac.com

HEADQUARTERS

HAUPPAUGE, NY

SIZE

500 - 1,000

FOUNDED

1995

CEO

PAILLA M REDDY

REVENUE

$50M - $200M

INDUSTRY

Pharmaceutical

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About Bactolac Pharmaceutical Inc

Bactolac Pharmaceutical is a nutritional supplement manufacturer led by a team of experienced scientists and pharmacists. Founded in New York in 1995, the companys goal has always been to provide high-quality vitamins and supplements at competitive prices to help customers become successful in the health and wellness supplementation market. A full-service health supplement manufacturer and vitamin supplier, we offer everything from product manufacturing to product testing, packaging, labeling, and distribution. These processes are all carried out in our high-tech, 350,000 square foot facility ...which houses innovative equipment and state-of-the-art laboratories. This facility is cGMP certified and meets all FDA requirements for nutritional supplement manufacturing. As a leading nutritional supplement manufacturer, Bactolac offers customers a wide variety of nutraceutical capsules, sublingual, soft gels, liquids, chewables, tablets, and powders for private label manufacturing. Our company provides turnkey services to clients for the creation, production and marketing of nutritional supplements for large, medium and small sized businesses. Whether youre looking to develop a single product or an entire product line, our technicians and scientists will provide the quality and service required from a high quality supplement manufacturer. Bactolac has been enabling our customers to reach their goals and is dedicated to giving you top quality products at affordable prices. We invite you to visit Bactolac in person. We are happy to arrange a tour and meeting for our potential partners. Come see why Bactolac is the future of private label contract manufacturing for the vitamin and nutraceutical industry. Visit our website, www.bactolac.com for further information, or give us a call at 631-951-4908 More
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The job skills required for Regulatory Affairs Associate include Standard Operating Procedures, etc. Having related job skills and expertise will give you an advantage when applying to be a Regulatory Affairs Associate. That makes you unique and can impact how much salary you can get paid. Below are job openings related to skills required by Regulatory Affairs Associate. Select any job title you are interested in and start to search job requirements.

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The following is the career advancement route for Regulatory Affairs Associate positions, which can be used as a reference in future career path planning. As a Regulatory Affairs Associate, it can be promoted into senior positions as a Regulatory Affairs Specialist II that are expected to handle more key tasks, people in this role will get a higher salary paid than an ordinary Regulatory Affairs Associate. You can explore the career advancement for a Regulatory Affairs Associate below and select your interested title to get hiring information.