Director, APAC, Regulatory Affairs, Hematology

Johnson & Johnson Pte Ltd; Singapore; On-site; SGD 180,000 - 240,000; Full time

Job summary

JOHNSON & JOHNSON Pte Ltd in Singapore seeks a Regional Regulatory Leader Asia Pacific to define and implement regional strategy for assigned products. You will lead regulatory input and coordinate with local teams, C-ROSS, and head office to align with business and R&D objectives.

You will consolidate regional requirements, manage health authority interactions, oversee product variations and renewals, and guide manufacturing site collaborations to ensure compliant registrations across AP

Responsibilities

• The Regional Regulatory Leader Asia Pacific (AP) defines and implements the regional strategy for assigned products.
• Leads regulatory input for assigned TAs/products and aligns with global regulatory strategy.
• Identifies regional requirements for successful regulatory filings for new products/indications.
• Consolidates strategy and prioritization of AP countries in line with business and R&D objectives.
• Manages interactions with local/regional manufacturing sites for registrations and packaging components.
• Provides regulatory intelligence to regional management and head office and supports implementation of regional strategies (e.g., generics, biosimilars).
• Oversees preparation for health authority meetings and presents to health authorities when required.

Job description

At Johnson & Johnson,we believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented, treated, and cured,where treatments are smarter and less invasive, andsolutions are personal.Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity.Learn more at jnj.com.

As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit.

Please note that this role is available across multiple countries and may be posted under different requisition numbers to comply with local requirements. While you are welcome to apply to any or all of the postings, we recommend focusing on the specific country(s) that align with your preferred location(s):

China R-110634, Japan R-110635, Singapore R-108238

Remember, whether you apply to one or all of these requisition numbers, your applications will be considered as a single submission.

Job Function:

Regulatory Affairs Group

Job Sub Function:

Regulatory Affairs

Job Category:

People Leader

All Job Posting Locations:

Singapore, Singapore

Job Description:

Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow.

Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way.

Learn more at https://www.jnj.com/innovative-medicine

POSITION SUMMARY:

The Regional Regulatory Leader Asia Pacific (AP) is a member of the Global Regulatory Affairs organization. The position resides in the AP region and is responsible for working with the local regulatory affairs departments, AP Integrated Value Teams, AP Therapeutic Area SLT and head office-based team members (e.g., C-ROSS Major Submissions) to define and implement the regional strategy for assigned products. The position is accountable for leading and providing regulatory strategic input for assigned TAs/products. The position is accountable for leading and providing region or country strategic input into the global regulatory strategy and identifying regional requirements for successful regulatory filings for new products/indications, including the opportunity for placement of clinical trials within the region. The position is responsible for consolidation of strategy and prioritization of AP countries, including Japan and China that are aligned with business and R&D objectives.

The position also ensures (either directly or through a partnership with C-ROSS Lifecycle Submission team) that product variations, including labeling changes, supplements, amendments, product license renewals are effected in the region. Furthermore, this position provides regional affiliates with timely responses to Health Authority enquiries and gives general regulatory support to all affiliates in the region for the pharmaceutical sector business. This support includes J&J global products as well as licensed products (global, regional, local) and regional/local developed products.

Position will ensure that interactions with local/regional manufacturing sites are managed.

Position will also manage interactions with manufacturing sites as required to ensure the availability of proper standard export packaging components for product registration.

Position will work with regulatory policy professionals as well as local affiliates to keep track of changes in country regulatory requirements and provide regulatory intelligence to regional management and head office. These activities would also include the support to regional and local implementation of strategies (e.g., generics, biosimilars, etc).

Position will oversee/ensure adequate preparation for health authority meetings, and will need to attend and provide presentations to health authorities, where necessary.

Directs Managers and/or senior individual contributors in a matrix environment, and is accountable for meaningful career development conversations and regular coaching and feedback.

Responsible for managing operational aspects of their teams (e.g., budget, performance, and compliance), as well as implementing workforce and succession plans to meet business needs.

Proactively creates a purpose driven environment by aligning Johnson & Johnson’s Credo and Leadership Imperatives with the strategies and goals of the team and enterprise.

PRINCIPAL RESPONSIBILITIES for