Global Regulatory Associate in Montvale, NJ at Apex Life Sciences

Date Posted: 2/28/2018

Job Snapshot

  • Employee Type:
  • Location:
    Montvale, NJ
  • Job Type:
  • Experience:
    Not Specified
  • Date Posted:
  • Job ID:

Job Description

Apex Life Sciences is in search of a Regulatory Associate for an immediate opening. Please send your resume to for consideration and reference “Regulatory Associate” in the subject line.

Individual will assist Global Regulatory Sr. associate to: 
• Develop regulatory strategies for the Category with a commercial mindset 
• Identify regulatory possibilities to shape future policy 
• Gather and disseminate regulatory & competitive intelligence for Power Brands 
• Collaborate across Regulatory to define development plans and timings of projects 

Principal duties and responsibilities will include: 
• Work collaboratively with Global Regulatory Sr. associate and other personnel in order to define and implement the regulatory strategy 
• Work collaboratively with Regulatory Compliance and Post Approval Maintenance (PAM) groups to assist with compliance for existing products. 
• Assist in monitoring, collecting, interpreting and sharing with business partners, including Policy and innovation regulatory team to map issues and trends that will impact company products, policies and procedures. Assist in the development of strategies and plans of action to address them. 
• Advise R&D personnel on data requirements for NPD/EPD projects to ensure regulatory compliance 
• With input from business partners provide Strategic Regulatory advice to Category Development regarding safety, labelling, communications and PR related issues 
• Assist in the preparation of responses to address significant regulatory and PR issues in the assigned Category 
• Provide strategic support to colleagues in Regulatory Compliance and Regulatory Operations to achieve business objectives. 
• Devise, and deliver to business partners, training materials that optimally prepare the business for the present and future regulatory environment. 
• Lead projects from reg perspective with the supervision of Sr. associate 
• Assess raw material documentation and create a gap analysis. 
• Gather feedback from Local regulatory teams and negotiate different regulatory paths to meet objectives. 
• Generate regulatory documentation e.g regulatory strategy, INCI, GPC… 

Key Challenges: 
• Keep on top of the ever changing legislative environment and ensure that all relevant parties are kept up to date with the changing legislative scene. 
• Deal with constant changes which require regulatory action with the complexities that go along with assigned Category products. 
• Meeting business / project deadlines in a pressurised environment 
• Building relationships with regulatory personnel around the world and internal and external stakeholders. 

• A minimum of a Bachelor’s degree in Chemistry, Biology or other technical discipline relevant for the assigned Category (medical sciences) 
• Prior experience in US-FDA (OTC monograph) and/ or European Biocides is a plus 
• Ability to understand and interpret directives and regulatory guidelines and communicate them effectively to the relevant stakeholders. 
• In line with company core values, the candidate will be achievement focused and able to work in a direct and often pressurized environment. Entrepreneurial skills in terms of innovation and problem solving are key along with tenacity, tough-mindedness and ability to influence and demonstrate strong team working abilities and commitment 
• Ability to work in an international and high agility environment 
• Result-oriented, entrepreneurial and self-motivating 
• Strong negotiating and interpersonal skills 
• Commercial understanding of operational business issues 
• Ability to understand of marketing strategy and planning issues 
• Ability to understand category strategy and consumer issues in relevant areas 
• Ability to transform solid thinking into action 
• Openness to change and ability to think out of the box 
• PC proficiency is needed