Senior Regulatory Affairs Associate

The purpose of this role is to execute OTC regulatory activities for new product registrations and life-cycle and maintenance for the portfolio of products defined by the US Business Units.

Key Responsibilities:

• Represent USRA on assigned projects, provide guidance on OTC drug regulatory pathways (monograph, NDA).
• Develop regulatory strategies and documents for new product launches and maintenance of current products, aligned with the regulations
• Develop a regulatory label for OTC products, review claims and copy
• Participate in the review of promotional materials
• Support end-to-end regulatory compliance of products in remit.
• Applies system and procedure updates to maintain up to date technical product records
• Identifies and participates in process improvements within US Regulatory Affairs
• Interact with colleagues in other global functions to support global programs
• Effectively communicates regulatory technical requirements and guidelines, facilitating timely and complete submissions
• Develop up-to-date knowledge of guidelines and regulatory requirements, as well as technical trends

QUALIFICATIONS

• Bachelor’s degree in Pharmaceutical or Life Sciences or equivalent regulatory experience
• 2-4 years’ experience in regulatory affairs including chemistry, manufacturing and controls, and over the counter experience, preferably within a CPG/Consumer Healthcare/Pharma related industry.
• Experience and knowledge in Quality, product development and manufacturing areas.
• Experience working on FDA applications, OTC monograph products, chemistry, manufacturing and controls
• Proficient knowledge in US FDA regulations