Global Director of Clinical & Regulatory Affairs
helenoftroy

Marlborough, Massachusetts

Posted in Sales


This job has expired.

Job Info


Join our Beauty & Wellness Team at Helen of Troy as our Global Director of Clinical & Regulatory Affairs (hybrid work onsite and from home), and make an immediate impact on our trusted brands; Honeywell , PUR , Braun , and Vicks . Together, we build innovative and useful products that elevate people's lives everywhere every day!

Look around your home, and you'll find us everywhere:

In your kitchen, living room, bedroom, and bathroom. We are already making your everyday lives better. We are powered by knowledgeable, enthusiastic, and forward-thinking people committed to developing a culture of inclusion. Whether you are just starting your career or in need of a challenge, we recognize, develop, and empower talent!

What you will be doing:

Oversees United States of America (US), Canada, Asia Pacific, Latin (LA), and South America (SA)

Leadership

  • Demonstrate a higher level of leadership and people management skills to address the intricate areas of issues.
  • Supervise personnel as necessary and facilitate cross-functional resolutions.
  • Collaborate with business and marketing groups to ensure regulatory and clinical activities are aligned with business needs.
  • Be proactive in resolving issues and providing insights and action plans.


Clinical Affairs
  • Clinical Trial Management: Continue to supervise Clinical trials with minimal oversight.
  • Work with IRB's and Ethics Boards to get clearance. Run Clinical Data and partner with biostatisticians to write final reports
  • Write CEP's, CER's, Post Market Surveillance Plans and Reports, Post Market Clinical Follow-up Reports, and other post-market documents as necessary.
  • Become proficient at writing and publishing articles.


Continuous Improvement
  • Serve as a regulatory expert; develop and maintain a detailed understanding of government policies, regulations, and guidelines related to labeling, promotion, and advertising
  • Work closely with US, Europe, and Asia regulatory affairs managers to provide and acquire the required documentation for product registrations.
  • Partner with the marketing product category managers on labeling development and revisions to assure compliance with government requirements.
  • Support the VP Global - Regulatory Affair in the implementation and maintenance of ISO 13485 and ISO9001 compliance and procedures and the Helen of Troy Health & Home Quality Manual Standard Operating Procedures.
  • Alert upper management of any issues or potential problems; make recommendations as appropriate.


Regulatory - Premarket and Post Market
  • Run the Regulatory registrations globally. Handle OTC Drug Annual reports.
  • Work with engineering to finalize regulatory plans.
  • Lead the Regulatory activities associated with the development and revision of labeling, advertising, promotional and scientific materials, and publications for marketed products in support of the assigned product categories.
  • Review Engineering Change Requests (ECR) and make disposition per the appropriate SOP for a full range of products for submissions and risk activities.
  • Review all artwork and make disposition per the appropriate SOP for all products of responsibility.
  • Work with marketing to substantiate product claims and with the engineering product category managers during product development and revision to assure appropriate efficacy data is acquired to support all labeling claims
  • Maintain Helen of Troy Health & Home and relevant affiliates for compliance with government requirements for the importation and distribution of products in Canada. (e.g., permits, licenses, registrations, and labeling)


Skills needed to be successful in this role:
  • High level of professionalism.
  • Ability to communicate and work with all levels of management and external agencies.
  • Results orientation, sense of urgency, good judgment, and attention to detail.
  • Must be flexible and able to optimally lead multiple challenging priorities for multiple customers.
  • Seeks assistance when addressing topics requiring risk management.
  • Track and maintain registration periods to meet registration dates and required follow-up for accuracy for a large group of registrations.


Minimum Qualifications:
  • Bachelor's or Master's Degree, or Ph.D. depending on work experience.
  • Minimum of 7-10 years of clinical study experience in a regulated industry.
  • Good understanding of most requirements pertaining to each product category (Federal Drug Administration, Environmental Protection Agency, Consumer Product Safety Commission, USA state environmental agencies, and LA/SA Health Ministries, e.g., labeling, registration, revisions, importing, exporting, distribution reporting).
  • Proficient PC skills (e.g., MS Office, Oracle, Business Objects, FileMaker).
  • Ability to travel (10-20%).


Preferred Qualifications:
  • Regulatory Certifications.


Wondering if you should apply? Helen of Troy welcomes people as diverse as our brands. Have the confidence to come as who you are because your point of view, skills, and experience will make us stronger. If you're eager to share new ideas and try new things, we want to hear from you.

#LI-AB1

#LI-Hybrid

For more information about Helen of Troy, visit www.helenoftroy.com . You can also find us on LinkedIn , Glassdoor , Facebook , Instagram and Twitter .

Helen of Troy is an Equal Opportunity/Affirmative Action Employer. We are committed to developing a diverse workforce and cultivating an inclusive environment. We value diversity and believe that we are strengthened by the differences in our experiences, thinking, culture and background. We do not discriminate on the basis of race, color, religion, sex, national origin, sexual orientation, gender identity, age, marital status, disability, protected veteran status or any protected basis.

We will provide individuals with disabilities reasonable accommodation to participate in the job application process. If you would like to request an accommodation, please contact Human Resources at (915) 225-8000.

Incorporated in1968,Helen of Troy has grown into a leadingglobal consumer products company with career opportunities in North America, South America, Europe and Asia. We offer creative solutions for our customers through a diversified portfolio of well-recognized and widely trusted brands, including OXO®, Hydro Flask®, Osprey®, Honeywell®, PUR®, Braun®, Vicks®, Hot Tools®, Drybar®. Most of these brands rank #1 or #2 in their respective categories.

We boldly bring brands into our family, where we nurture what makes them great.We collaborate internally and externally, always striving to provide the consumer-centricinnovation, operational excellence, scale, global reach, and stellar shared services tomake them soar.

The above statements are intended to describe the general nature and level of work performed by people assigned to this classification. They are not intended to be construed as an exhaustive list of all responsibilities and duties required of personnel so classified. Management retains the right to add or to change duties of the position at any time.


This job has expired.

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