Regulatory Affairs Senior Associate

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