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Sr. Mgr., Global Regulatory Operations in Ronkonkoma, NY at The Nature's Bounty Co.

Date Posted: 1/7/2019

Job Snapshot

  • Employee Type:
    Full-Time
  • Job Type:
  • Experience:
    At least 7 year(s)
  • Date Posted:
    1/7/2019

Job Description


Company Description  

For more than 70 years, The Nature’s Bounty Co. has enriched the lives of consumers around the world and stood as the leader in health and wellness by introducing innovative products and solutions to the marketplace. Putting science and the highest quality standards at the heart of our business, the brands of The Nature’s Bounty Co. are some of the most trusted in the world. Always motivated by nature’s bountiful effects on people’s health, our vision for health and wellness has inspired leading brands such as Nature’s Bounty®, Sundown Naturals®, Solgar®, Osteo Bi-Flex®, Ester-C®, MET-Rx®, Pure Protein®, Balance®, Body Fortress®, Puritan’s Pride® and Organic Dr.®, among others. As a leading global manufacturer, marketer, distributor and retailer of vitamins, nutritional supplements, sports & active nutrition and ethical beauty products, The Nature’s Bounty Co. is committed to supporting wellness in all its forms.


Job Description  

The Nature's Bounty Co.  is currently seeking a seasoned regulatory professional with experience of Regulatory Operations (RO) including label development and documentation management, ideally in a global capacity.  This is an exciting opportunity for the incumbent to transform the existing Regulatory Operations shared service functions into a global function recognized for its regulatory competence and ability to meet compliance obligations around the world in an efficient and effective way.  The role will be responsible for oversight of all Regulatory Operations teams including Label Development, Data Management & Compliance and Product Vigilance. 

Responsibilities include, but are not limited to:

  • Demonstrate strong people management skills, leading a team of ~20 people across multiples levels of experience.
  • Manage the activities of regulatory operations team responsible for functional activities, including label development, data management & compliance, and product vigilance. 
  • Label Development:  Have oversight and responsibility for the development, revision, review and maintenance of primary labeling documents for US, EU and other International markets.
  • Minimize service times and ensure quality of labeling deliverables (e.g., alignment of manuscript text with regulatory requirements, number of iterations, version control, consistency between labeling documents).
  • Data Management and Compliance:  Responsible for supplier and co-manufacturer document procurement and management ensuring finished product compliance.
  • Conduct raw material reviews versus regulatory standards and internal positions/policies ensuring compliance.
  • Responsible for the compilation of product dossiers enabling registration, re-registration, exportation or resolution of inquiries/issues as appropriate
  • Provide access to documentation enabling response to technical inquiries or providing the responses to technical inquiries.
  • Support the global change control process and coordinate global regulatory input on proposed changes.
  • Provide support on corporate positions and approaches to the regulatory affairs region teams responsible for the regulatory submissions or registrations enabling in market compliance.
  • Product Vigilance:  Responsible for the review, assessment and reporting of all adverse events,  post market surveillance and product lifecycle contributions in line with regulatory obligations for The Nature’s Bounty Co.’s products.
  • Develop and implement criteria for escalation to Nutrition and Scientific Affairs and clear roles and responsibilities for conducting such risk assessments and make business recommendations to the broader R&D/ Quality/Legal community.
  • Develop and implement regulatory positions/ Guidance / SOPs consistent with corporate policy and global regulatory requirements.
  • Develop and maintain strong partnerships with critical functions such as quality and product development as well as broader regulatory affairs team globally.
  • Provide monthly ‘service’ reports for all teams providing visibility of throughput, productivity & efficiency
  • Maintain proficient levels of knowledge and understanding for applicable laws and regulations across the team, as applicable, most notably  FDA requirements for Foods, Dietary Supplements and Cosmetics, ensuring compliance obligations are met
  • Lead efforts to continuously improve RO to ensure speed of delivery whilst maintaining accuracy and compliance

Qualifications  

  • A recognized expert in dietary supplement regulations the incumbent should have a minimum of 7+ years deep regulatory and compliance experience.
  • Management of a regulatory compliance function in at minimum a US market capacity is essential; the lead candidate will be able to demonstrate his/her ability to lead a team supporting additional markets globally.
  • Solid understanding of the consumer healthcare/nutraceutical industry landscape and market trends.
  •  Demonstrated leadership skills in leading a dynamic, high-performing team by setting and meeting goals and motivating cross-functional teams.
  • Operational experience: Proven ability to build regulatory processes and systems. Quality experience/background is a plus.
  • Bachelor degree required; Advanced degree desirable.
  • Shape strategy: Pro-active, creative, forward-thinker with the ability to think innovatively about integrated strategies for regulatory operations while accurately anticipating future consequences and trends.


Additional Information  

The Nature's Bounty Co. is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status. 

The Nature's Bounty Co. offers a competitive salary and a comprehensive benefits package, which includes health and dental plans, voluntary short-term and long-term disability, life insurance, flexible spending accounts, 401(k), tuition reimbursement, generous associate discounts and more! 

Please contact Human Resources at 631-244-2120 if you should need a reasonable accommodation to submit your information for our on-line job postings.