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Senior Specialist, Regulatory Affairs (Remote Based)

Location: 

Allendale, NJ, US

Req ID:  2251
Job Type: 
Edgewell is a global team of over 6,000 visionaries, doers and makers. Our secret is people, and we have an inspiring and collaborative global force of them. Our portfolio of over 25 brands touches lives in more than 50 countries by making useful things joyful. Together, we reimagine good mornings and endless summers, strive for more sustainable ways to beautify and bond, and do it all with not only confidence but determination.

Position Summary:

With light supervision, provide regulatory input and technical guidance for Edgewell’s OTC Drugs and Cosmetic business segments with focus in the region of North America (US – CANADA). Works on regulatory submissions, registrations, supports new product development and commercial teams, along with regulatory work.

 

Accountabilities

  • Develop Regulatory Affairs strategic and tactical plans in accordance with Department and Company objectives. 
  • Provide regulatory guidance, risk assessment and management throughout the product lifecycle. 
  • Prepare regulatory submissions to health authorities, pre-market registration, notification, ensuring submissions meet relevant in-country regulatory requirements. Develop strategic and tactical submission plans. Ensures all governmental and industry reporting systems and documentation comply with regulatory requirements for OTC and Cosmetic products.  
  • Provide on-going regulatory support to New Product Development and Commercial project teams on regulatory issues and questions. Assess regulatory pathways for new products, as well as for amendments to existing products.
  • Support new and currently marketed products, including label review and approval of artwork for the US and Canada. 
  • Confirm product or formula acceptability in local markets. 
  • Research and monitor changes in regulations and standards that may impact the business. 
  • Complete Government and retailer regulatory surveys. 
  • Attend NPD meetings and collaborate with Marketing, Program Management, Operations and other cross-functional team members to meet required deadlines. 
  • Prioritize and guide the work of colleague(s) to ensure commitments are met. 
  • Author Internal Guidance Documents, Protocols, Working Tools, Standard Operating Procedures for routine Regulatory transactions and work processes. 
  • Maintain matrices and tracking sheets for Regulatory transactions. 
  • Represent Regulatory to Core Team Meetings as assigned. 
  • Build library and network of regional regulatory resources. 
  • Maintain specialized product category knowledge.

 

Required Education, Skills and Experience

  • Bachelor’s degree in regulatory affairs, chemistry, engineering, life sciences, international business, business economy or other related field.
  • A minimum of 6 years of related experience within the OTC and Cosmetic Products regulatory platforms. 
  • Sound knowledge of and demonstrated experience with product registrations or notifications regulatory procedures and submissions with focus on North America markets. 
  • Sound knowledge of the Regulatory framework for OTC Drugs and Cosmetic Products, required. 

 

Desirable Education, Skills and Experience

  • Experience in regulatory compliance standards for Personal Care Products in North America a plus
  • Skin care products (OTC or Cosmetics) experience a big plus
  • Demonstrated proficiency with regulatory planning/strategy & submission planning / preparation. 
  • Strong knowledge of relevant laws, regulations, standards and guidelines affecting personal care consumer products.
  • Assessment, evaluation and critical thinking skills. 
  • Good negotiation skills, diplomacy and professional judgement.
  • Effective verbal / written communication, interpersonal, and influencing skills. 
  • Ability to interface with internal and external contacts at all levels. Ability to clearly communicate technical and non-technical information via verbal presentations and in writing. 
  • Good computer skills. Proficiency with Word, Excel, Access/databases e-mail and internet applications. 
  • Strong attention to detail and good record-keeping skills. 
  • Excellent organizational, prioritization and follow up skills. Ability to handle multiple tasks / projects simultaneously. 
  • Ability to think and act independently and to make sound decisions. 
  • Demonstrated ability to juggle multiple competing priorities and to complete projects on time. Service-oriented. 
  • Good analytical and problem-solving skills. 
  • Demonstrated ability to complete projects on time. 

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Working Relationships

Key relationships internally will include Product Safety, Research and Development, Technical Services, Legal, Quality, between others.

 

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Edgewell is an equal opportunity employer. We do all we can to create a collaborative and diverse global team, where good ideas can thrive, and our colleagues can learn and lead. We prohibit discrimination based on age, color, disability, marital or parental status, national origin, race, religion, sex, sexual orientation, gender identity, veteran status or any legally protected status in accordance with applicable federal, state and local laws. We listen deeply and speak directly to create an environment that’s open to difference. We aim to bring joy to not only the products we create and the people we serve, but our colleagues across the globe too.


Nearest Major Market: New Jersey