Job Title: Regulatory Affairs Senior Associate Location: Warren, NJ 07059 Duration: 12 Months (Possibility of extension depending upon business requirements and performance)
Job Summary:
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
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 pay range is $49.00/hr - $49.15/hr.
