[Close] 

Director of Regulatory Affairs & Quality Assurance

Director of Regulatory Affairs & Quality Assurance



For more than 85 years, our client has been a visionary leader in whole food philosophy! They offer over 350 high-quality supplements with whole food ingredients. The organization is vertically integrated - farm to fork - seed to supplement! We have been retained to fill the critical role of Director of Regulatory Affairs & Quality Assurance for this rapidly growing company!



Under the direction of the VP, General Counsel, the Director of Regulatory Affairs & Quality Assurance will be responsible for providing strategic leadership for regulatory strategy including agency interactions, regulatory compliance, regulatory advice and counseling, advertising and promotion review. In addition, S/he will have responsibility for product labeling practices across the life cycle of the product portfolio. An integral part of this role is to foster strong relationships and advocacy with FDA and other regulatory agencies as well as strong collaboration across internal departments and stakeholders.



This position will be based in Palmyra, WI. Many candidates commute from the greater Milwaukee or Madison areas to Palmyra. We will relocate candidates for this role.



Essential Functions




  • Research and advise cross-functional partners regarding industry-specific regulatory compliance and requirements.


  • Provide regulatory strategic leadership supporting commercialization and marketing activities and requirements for approved products in the US and Canada.


  • Provide regulatory guidance to support internal and external audits.


  • Assess regulatory intelligence to identify impact upon products, internal processes and projects.


  • Manage a team of regulatory & quality assurance staff.


  • Keep peers and superiors apprised of expected changes to the regulatory landscape affecting existing and future Company products and provide strategic and tactile direction to drive cross-discipline consistency in regulatory approach and planning.


  • Act as primary strategic contact with the FDA and other regulatory agencies to enable execution of company regulatory goals.


  • Develop and design robust regulatory structures, processes and procedures and budget forecasting based upon expert understanding, industry experience, and insight into future direction.


  • Support medical affairs and corporate activities including review of publications and other legal or public disclosures.


  • Provide guidance to business development regarding critical evaluation of potential product opportunities and the necessary steps or cautions about the activities.


  • Maintain solid understanding of current and pending supplement labelling regulatory requirements that may affect existing nutrition and labelling compliance programs or necessitate new programs or requirements.


  • Lead the team to apply scientific principles and knowledge to evaluate ideas and opportunities relative to the business strategies and opportunities (competitive insights, brand positioning/standards, health& wellness nutritional platforms, emerging issues) for key innovation projects; synthesize point of views/positions that are best for the business.


  • Ensure formula changes and label revisions comply with regulatory requirements.


  • Foster individual team member development and build strong, effective teams by setting clear goals and establishing success measures.


  • Provide technical regulatory guidance to Marketing and Innovation teams in collaboration with the Legal department to ensure regulatory compliance of marketing and practitioner education materials.




Qualifications:




  • Master?s Degree or PhD in a related field of study preferred


  • Minimum of 10 years of relevant experience in the dietary supplement, pharma, food or nutrition industry


  • Knowledge of current FDA regulation and enforcement policies within the food and dietary supplement industries


  • Demonstrated leadership competency



see job description




Don't Be Fooled

The fraudster will send a check to the victim who has accepted a job. The check can be for multiple reasons such as signing bonus, supplies, etc. The victim will be instructed to deposit the check and use the money for any of these reasons and then instructed to send the remaining funds to the fraudster. The check will bounce and the victim is left responsible.

More Jobs

Director of Regulatory Affairs & Quality Assur...
Madison, WI The Carlisle Group
Director of Regulatory Affairs & Quality Assur...
Milwaukee, WI The Carlisle Group
Regulatory Affairs Policy Director
Beloit, WI Kerry Inc.
Assistant Director of Nursing (ADON)
Brookfield, WI Ascension Living
Director of Managed Care
Oconomowoc, WI Rogers Memorial Hospital