Regulatory Affairs Manager, APAC
JUUL's mission is to improve the lives of the world’s one billion adult smokers by driving innovation to eliminate cigarettes. JUUL is the number one US-based vapor product. Headquartered in San Francisco and backed by leading technology investors including Tiger Global, Fidelity Investments and Tao Invest LLC, JUUL Labs is disrupting one of the world’s largest and oldest industries.
We’re an exceptional team with backgrounds in technology, healthcare, CPG and biotech, and we’re growing rapidly to deliver on our mission. We’re actively looking to hire the world’s best scientists, engineers, designers, product managers, supply chain experts, customer service and business professionals.
ROLE AND RESPONSIBILITIES:
JUUL Labs is searching for a Regulatory Affairs Manager- APAC, to join our Regulatory Affairs Team. Reporting to the Senior Director, Regulatory Affairs, you will oversee the regulatory program dedicated to JUUL Labs’ signature brand of Electronic Nicotine Delivery Systems (ENDS) with a focus on APAC. In this highly visible role, you will assist in defining APAC regulatory requirements for the all ENDS program and ensure they meet the regions need.
- Develop strategies for successful APAC marketing authorization of JUUL’s signature brand of Nicotine Delivery Systems (ENDS), also known as e-cigarettes
- Interpret existing or new regulatory requirements for the region for ENDS for filling, clinical studies, testing and communicate to stakeholders to ensure APAC formulations comply to standards
- Provide regulatory guidance and support to country teams on testing and standards requirements to support country filing process.
- Prepare meeting packets and participate in meeting discussions with APAC health authorities as required;
- Review promotional and advertising materials, assist in complaints resolution, vigilance and medical device reporting efforts.
- Represent the regulatory affairs function on JUUL multidisciplinary teams dedicated to country launches
- Coordinate with international regulatory and/quality leads on deliverables that facilitate timely market introductions in APAC
- Prepare comprehensive database on all APAC country requirements on registrations/notifications, labelling, legislations and monitor regulatory policy changes
- Perform chemistry, manufacturing & controls (CMC) assessments
- Maintain establishment registrations and listings information, as required.
PERSONAL AND PROFESSIONAL QUALIFICATIONS:
- Minimum of 10 years of regulatory experience in industries, such as Pharmaceutical, Medical Device, Combination product, with an aptitude and willingness to learn the ENDS product area
- The ability to understand and interpret legislation, regulations and complex guidance that must be translated into actionable plans or approaches.
- Versatility in knowledge areas including product development, clinical trial design, behavior science research, and toxicology.
- A sense of courage and a real passion for all things regulatory related
- A passion for implementing processes that create efficiencies to streamline the regulatory submission process
- Highly proficient communication skills, both written and verbal. Have the ability to clearly and concisely explain complex scientific concepts to audiences with extensive technical expertise and to those without.
EDUCATION: Bachelor’s degree in a science related discipline including, but not limited to, biology, chemistry, aerosol science, pharmacology and engineering.
JUUL LABS PERKS & BENEFITS:
- A place to grow your career. We’ll help you set big goals - and exceed them
- People. Work with talented, committed and supportive teammates
- Equity and performance bonuses. Every employee is a stakeholder in our success
- Boundless snacks and drinks
- Cell phone subsidy, commuter benefits and discounts on JUUL products
- Excellent medical, dental and vision benefits
- Location. Singapore
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