Regulatory Affairs Senior Specialist

hace 1 semana

Asia, Perú Johnson & Johnson A tiempo completo

Description

**What you will do**

The Regulatory Affairs Senior Specialist is responsible for
- Lead China RA Regulatory activities & innovative regulatory area. Build strategic regulatory insights into product registration strategies to ensure fast introduction of new products by securing import licenses and domestic licenses.
- Proactively partner with internal business stakeholders (local, regional, global), regional franchise teams and Cross-Sector RA partners to develop of innovative regulatory strategies ensuring that regulatory requirements are incorporated upfront and project risks are understood and mitigations in place.
- Develop problem-solving strategies which drive efficiency within the project teams, ensure product compliance and deliver high-quality submissions per project timelines for both innovation and Life Cycle management projects (e.g., variations, renewals etc.)
- Key Responsibilities
- RA SME for Drug AEP DMF Regulation and implementation.
- 1) API re-registration regulation and variation regulatory support, China HA has the same administration of Drug and APIs, which means the life circle management of APIs is stricter than before, including period renewal requirement, post market variation approval, etc.

2) The new reg. implication brings us more strategic thinking & reg. interpretation works on API and excipients. There will be 100+ bexcipents regulations and packaging material regulation be draftted in the coming year.
- Jupiter DP registration Submission.
- 1) Drive innovative way and generate data to maximize existing product claim opportunity, by leveraging scientific data & consensus to get insert approved (save time & budget otherwise require clinical studies).
- 2) Support drug product registration produced in XJP plant. Familiar with AEP DMF requirement, support on API variation and re-registration activities.
- 3) The Jupiter products post market management becomes more complex with the development of Project WU and ongoing projects, e.g., API legacy CDE homework, address correction remediation, legacy issue of PET OOS for DAK Cream, etc. which will bring more complex communication and strategic thinking to deal with the ambiguities.
- Labeling Innovation and CCDS implementation for drug products
- 1) HA will enhance the deployment for Elderly-Oriented Simplification of the Drugs instruction(PI), Kenvue is required by local FDA as one of the key participants of this innovation, there would be more labeling regulation discussion with HA and lead the industrial opinions, and support on the internal implementation.
- 2) Responsible for CCDS implementation in CN, responsible any HA comminciation if needed.
- Support on external regulation shaping. To monitor the regulatory environment locally, and globally and provide timely assessments to business leaders of the impact of new/changing regulations on the current and future pipeline. Provide consultation, interpretation and advice to relevant departments to ensure on-time compliance with regulatory guidelines/directives/national requirements.

**Qualifications**:
**What we are looking for**

Required Qualifications
- Multinational company experience and basic understanding of US and EU regulatory framework desired.
- Master’s degree in pharmacy, Biology, Chemistry or related Life Sciences.

Primary Location Asia Pacific-China-Beijing-Beijing

Job Function Regulatory Affairs

  • Regulatory Affairs Senior Specialist

    hace 1 semana

    Asia, Perú Johnson & Johnson A tiempo completo

    Description The Regulatory Affairs Senior Specialist is responsible for - Lead China RA Regulatory activities & innovative regulatory area. Build strategic regulatory insights into product registration strategies to ensure fast introduction of new products by securing import licenses and domestic licenses. - Proactively partner with internal business...

  • Senior Manager, Labeling Hub

    hace 6 días

    Asia, Perú Johnson & Johnson A tiempo completo

    Description **Who We Are** At Kenvue, we realize the extraordinary power of everyday care. Built on over a century of heritage and rooted in science, we’re the house of iconic brands - including NEUTROGENA®, AVEENO®, TYLENOL®, LISTERINE®, JOHNSON’S® and BAND-AID® that you already know and love. Science is our passion; care is our talent. Our...

  • Head of External Affairs, Asia

    hace 2 días

    Asia, Perú Drugs for Neglected Diseases Initiative A tiempo completo

    The Drugs for Neglected Diseases initiative (DNDi) is an international, not-for-profit research and development (R&D) organization that develops and delivers new treatments for neglected diseases affecting millions of the world’s poorest people. Together with more than 200 public research and industry allies worldwide, we use the power of partnership,...

  • Bd Coordinator

    hace 2 semanas

    Asia, Perú KM Talent A tiempo completo

    **Asia** Truly global firm with a strong APAC presence - Known for its outstanding service quality - Proven leadership - Junior specialists thrive in this firm - Opportunity to make an immediate impact Are you ready to take your business development skills to the next level? Our client, a leading global law firm brand, is seeking a junior BD specialist to...

  • Senior Scientist, Toxicology

    hace 2 días

    Asia, Perú Johnson & Johnson A tiempo completo

    Description Kenvue is currently recruiting for: **Senior Scientist-Toxicology - **This position reports into Director - Associate Director-Toxicology is based at Mumbai **Who We Are** At Kenvue, we realize the extraordinary power of everyday care. Built on over a century of heritage and rooted in science, we’re the house of iconic brands - including...

  • Senior Content Editor

    hace 2 días

    Asia, Perú Binance A tiempo completo

    Binance is the leading global blockchain ecosystem and cryptocurrency infrastructure provider whose suite of financial products includes the world’s largest digital-asset exchange. Our mission is to accelerate cryptocurrency adoption and increase the freedom of money. If you’re looking for a fast-paced, mission-driven organization where opportunities...

  • Senior R&d Manager Dr Ci: Labo

    hace 2 días

    Asia, Perú Johnson & Johnson A tiempo completo

    Description **What will you do** The R&D Senior Manager for Dr Ci:Labo has overall leadership for the R&D activities supporting China as the key growth market for Dr Ci:Labo dermo-cosmetics brand. The role will work directly with the Regional Commercial Leadership team, regional Supply Chain and regional and global R&D teams to: - Develop and shape a...

  • Senior Manager

    hace 2 semanas

    Asia, Perú Johnson & Johnson A tiempo completo

    Description Kenvue is currently recruiting for: **Senior Manager - Global Brand Protection** **Who we are** - At Kenvue, we realize the extraordinary power of everyday care. Built on over a century of heritage and rooted in science, we’re the house of iconic brands - including Neutrogena, Aveeno, Tylenol, Listerine, Johnson’s and BAND-AID® Brand...

  • Senior Business Development Manager

    hace 6 días

    Asia, Perú Binance A tiempo completo

    Binance is the leading global blockchain ecosystem and cryptocurrency infrastructure provider whose suite of financial products includes the world’s largest digital-asset exchange. Our mission is to accelerate cryptocurrency adoption and increase the freedom of money. If you’re looking for a fast-paced, mission-driven organization where opportunities...

  • Product Manager Toxin Binders

    hace 1 semana

    Asia, Perú EW Nutrition A tiempo completo

    EW Nutrition globally delivers optimum solutions for animal nutrition. Over 450 highly competent and motivated professionals are the basis for EW Nutrition’s continuous growth. The diversity of our employees is one of our critical success factors. We respect each other, try to continuously improve our organization and have a positive, solution-oriented...