Job description
Regulatory Affairs Manager, Healthcare
Parsippany, NJ
Competitive Salary & excellent benefits package
Leading a team in a fast-paced international business, you’ll play a critical role in driving innovation and developing new products. Responsible for your own category, you’ll:
- Navigate a complex and changing regulatory environment to ensure our product portfolio strategy supports our ambitious growth plans
- Anticipate and influence regulatory changes, lead our thinking about what is possible
- Define global registration dossiers and technical documentation
- Ensure the safety and efficacy of products.
…you’ve a scientific background and you understand Regulatory Affairs. You:
- Understand new product development, registration and submission processes
- Have led teams, maintaining a high attention to detail in preparing technical dossiers, variations and renewals
- Are an excellent communicator, using your expertise to influence others to make fact-based decisions
- Are results-orientated and entrepreneurial. Just like us.
You’ll love it because…
…you’ll get to make an impact like never before. You’ll be responsible for your own projects - we can’t wait to hear your ideas. The products you help us get out there will make people’s lives better. Our iconic brands will provide an incredible platform for you. And our dynamic, ownership-driven culture will help bring the very best out of you, every day.
Reckitt Benckiser is a global success story in Health, Hygiene and Home products. Our success is led by successful brands like Lysol, Durex, Clearasil, Finish, Mucinex, Woolite, and Resolve that aim to achieve global market leadership. Our vision is a world where people are healthier and live better. Our purpose is to make a difference by giving people innovative solutions for healthier lives and happier homes.
The Manager, Regulatory Affairs, Healthcare will be responsible for leading the Over-the-Counter (OTC) Regulatory team, and is a key participant on the Regulatory Affairs Team. This position reports into the Director, Regulatory Affairs, Healthcare.
Responsibilities:
- Manage day-to-day operations of the OTC team, including managing overall workload, development of team members, and ensuring all product and project-related milestones are met.
- Develop and implement Regulatory strategies to ensure successful launch, promotion, and compliance, for both marketed Healthcare products and products in development. Lead/co-lead meetings with FDA during product negotiations.
- Maintain close working relationship with the Global Regulatory Team to ensure alignment of local (US) Regulatory strategies with Global/Regional strategies.
- Provides Regulatory support and expertise to project teams, through Regulatory strategies and consultation on deliverables that could potentially impact the project/product.
- Ensure compliance with all internal and external regulatory requirements.
- Responsible for the analysis and evaluation of regulations and provides expertise in translating regulatory requirements into practical, workable plans in the US.
- Oversees the evaluation and analysis of the impact of trends relative to government regulatory agencies.
- Oversees, manages and implements the preparation of major regulatory filings, and ensures timely completion of routine regulatory submissions required for maintenance of in-market products. Reviews technical reports prepared in support of regulatory filings.
- Maintains close working relationship with R&D, Medical, Supply, Legal and Marketing staff to support Power of One (Po1) team structure and is the Po1 Regulatory lead with responsibility for influencing growth and development of the brands within the therapeutic area.
- Works with key trade associations and Regulatory Agencies to influence new regulations and guidance documents to align with RB vision and direction. Communicate changes to the business with Global and Local team while also applying to current project pipeline. Holds or seeks to attain key leadership-level role(s) within trade association.
Requirements:
- Bachelor's degree in science required. Advanced degree (i.e., Masters) in a scientific discipline desired.
- Eight to twelve years of direct, industry-related Regulatory experience in relevant industries with at least 5 years of experience in a senior Regulatory role. Experience with managing one or more direct reports strongly desired.
- Solid experience with Regulatory submissions (Rx and/or OTC) to FDA required. Experience with interfacing with Regulatory agencies (i.e., attendance at FDA meetings) highly desirable. Experience with international Regulatory submissions and compliance a plus.
- Experience in supporting launches and commercialization of pharmaceutical products in the US. Knowledgeable in current policies, practices, trends, technology, and information affecting the pharmaceutical industry. Knows how the pharmaceutical industry works and has an awareness of competitors and their products.
- Solid working knowledge of good manufacturing practices (GMPs), US pharmaceutical regulations, good clinical practices (GCPs) and good laboratory practices (GLPs).
- Excellent team interaction skills along with demonstrated ability to work on a cross-functional team and influence the decisions of a team.
- Effective verbal and written communication, along with negotiation skills required.
- Skilled in leveraging Microsoft Office programs and other relevant software. Proficient in navigating key external agency and trade association web sites. Technically savvy with the ability to quickly learn and become proficient within RB Systems.
Equality
At Reckitt, we recognise that in real life, great people don’t always ‘tick all the boxes’. That’s why we hire for potential as well as experience. Even if you don’t meet every point on the job description, if this role and our company feels like a good fit for you, we still want to hear from you. Come and join a team whose purpose is to protect, heal and nurture in the relentless pursuit of a cleaner and healthier world.
All qualified applicants to Reckitt will receive consideration for employment without regard to age, disability or medical condition; colour, ethnicity, race, citizenship, and national origin; religion, faith; pregnancy, family status and caring responsibilities; sexual orientation; sex, gender identity, gender expression, and transgender identity; protected veteran status; size or any other basis protected by appropriate law.
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