What are the responsibilities and job description for the Senior Regulatory Affairs Associate position at Xcede?
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