Regulatory Affairs Senior Manager

Lancesoft

Warren, NJ

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JOB DETAILS

SKILLS

Advertising, Agile Programming Methodologies, Biology, Biotech and Pharmaceutical, Chemistry, Communication Skills, Cross-Functional, Establish Priorities, FDA (Food and Drug Administration), FDA Requirements, Leadership, Maintain Compliance, Manufacturing, Medicine, Pharmacy, Policy Implementation, Presentation/Verbal Skills, Process Improvement, Product Documentation, Product Lifecycle, Product/Service Launch, Project/Program Management, Regulations, Regulatory Requirements, Risk, Risk Analysis, Risk Management, Team Lead/Manager, Team Player, Teleconferencing, Time Management

LOCATION

Warren, NJ

POSTED

6 days ago

Title: Regulatory Manager
Pay Rate $73.00 76.00/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 Manager
Job Purpose:
The purpose of this role is to execute OTC regulatory activities for new product 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...
Ensures cross-portfolio aligned regulatory strategy to deliver timely approvals for US submissions and OTC
Monograph product launches.
Develop and implement regulatory strategies and documents for new product launches and maintenance of
current products aligned with the regulations.
Support key processes and ways of working, regulatory labelling and artwork review and aligned with local
requirements.
Support the development of claims/advertising and promotion within the regulations, ensuring risks are
appropriately addressed and communicated.
Prepares registration files, briefing books, supplements, annual report files, and responses to Regulatory
Agency questions
Provides support, as needed, for meetings/teleconferences with US regulatory agency
Interacts with regulatory agencies to answer questions regarding submissions.
Ensures quality and process improvements within US and provides cross portfolio resources support as
appropriate
Manage compliance within defined portfolio/activity streams in line with Haleon expectations
Provides advice on US-specific activities and ways of working and processes;
Proactively identify potential risks and manage impact of regulatory changes within defined scope of
responsibility
Develop up-to-date knowledge of regulatory requirements, as well as technical trends Regulatory Affairs Senior Manager
Work with regulatory colleagues and other stakeholders to proactively look for opport unities and solutions to
challenges, including leading implementation of improvement initiatives

Basic Qualifications:

Bachelor s Degree in Pharmaceutical or Life Sciences, Chemistry, Biology, Medicine, or similar discipline
Minimum 8 years of experience in regulatory affairs
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
Demonstrated ability to lead projects or cross-functional teams

Additional Preferred Qualifications:

Advanced degree in Pharmacy, Chemistry, Biology, Medicine, or similar discipline
Experience at a large global pharmaceutical or OTC Client company
Experience leading global teams
Project management experience
Experience communicating with FDA (including FDA meetings, briefing books, and responses to Regulatory
Agency questions)
Agile and distributed decision-making using evidence and applying judgement to balance pace, rigor and risk
Commitment to delivering high quality results, overcoming challenges, focusing on what matters, execution
Implementing change initiatives and leading change
Sustaining energy and well-being, building resilience in teams
Continuously looking for opportunities to learn, build skills and share learning both internally and externally
Translating strategy into action - a compelling narrative, motivating others, setting objectives and delegation
Building strong relationships and collaboration, managing trusted stakeholder relationships internally and
externally

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/