Regulatory Associate

Lancesoft

Warren, NJ

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JOB DETAILS

SKILLS

Agile Programming Methodologies, Biology, Biotech and Pharmaceutical, Chemistry, Communication Skills, Cross-Functional, Detail Oriented, Establish Priorities, FDA (Food and Drug Administration), FDA Requirements, Healthcare, Leadership, Maintain Compliance, Manufacturing, Medical Equipment, People Management, Performance Metrics, Presentation/Verbal Skills, Process Improvement, Product Development, Product Documentation, Product Lifecycle, Product Reviews, Product/Service Launch, Project/Program Management, Regulations, Regulatory Compliance, Regulatory Requirements, Risk, Strategic Planning, Systems Maintenance, Team Player, Time Management, Writing Skills

LOCATION

Warren, NJ

POSTED

4 days ago

Title: Regulatory Associate
Pay Rate $47.00 49.15/hr on W2
Location:Warren, NJ 07059 (Onsite or 3 days in office - Hybrid)
Duration: 06 Months
Day Shift: 8 am - 5 PM

Job Description:
Regulatory Affairs Senior Associate
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 Client/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

About the Company

Lancesoft

We are a $125 Million, NMSDC-certified Minority & Woman owned Workforce Solutions Company headquartered in the DC metro area with presence across US with global presence - Canada, Mexico, India, UK, Malaysia, Indonasia, Hongkong, Singapore, UAE. We are specialized in providing Workforce Solutions, SOW project delivery, Engineering Solutions, Creative Services. We currently support 100+ Fortune companies globally and across multiple industry segments. We are currently supporting several massive programs across industry segment nationally/globally (Intel, Ally, AMD, QUALCOMM, Morgan Stanley, Kraft/ Mondelez, MNP, Amdocs, Dell, SanDisk, Medtronic, Becton Dickinson, GE, Lockheed Martin, UTC, L-3 Communications, Caterpillar, BMW, Mercedes Benz, National Grid, Dominion, Energy Future Holdings, PSEG, 3M, Fidelity, Aetna, Humana, Johnson & Johnson, Pfizer, Merck etc).

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender, identity, national origin, disability, or protected veteran status.

COMPANY SIZE

2,000 to 2,499 employees

INDUSTRY

Staffing/Employment Agencies

FOUNDED

2000

WEBSITE

http://www.lancesoft.com/

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