Job Title: Regulatory Affairs Senior Associate
Location: Warren, NJ 07059 (HYBRID, Onsite or 3 days in office)
Duration: 6 Months (Possibility of extension depending upon business requirements and performance)
Shift: 8-5
- Description:The purpose of this role is to execute OTC regulatory activities for new products registrations and life-cycle maintenance for the portfolio of products defined by the US Business Units.
Key Responsibilities:
These responsibilities include some of the following.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 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
- Regulatory Affairs Senior Associate
- Excellent communications skills, stakeholder management and enjoys working in multidisciplinary teams
- Ability to manage prioritize projects of high complexity
- Experience leading end-to-end regulatory process in new product launches
Additional Preferred Qualifications:
Knowledge and experience of US regulatory framework for OTC drugs, OTC medical devices
- Ability to ensure compliance standards and key performance indicators are met
- Regulatory expertise in knowledge of the regulatory lifecycle
- Ability to interact at many levels
- Technical knowledge
- Minimum 2 years of experience in regulatory affairs
- Competencies and Skills:Agile, attention to detail, written and verbal communication skills– using evidence and applying judgement to balance pace, rigor and risk
Applicant Notices & Disclaimers
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At SPECTRAFORCE, we are committed to maintaining a workplace that ensures fair compensation and wage transparency in adherence with all applicable state and local laws. This position's starting pay is: $45.00/hr.