Manager Regulatory Affairs Process Support, Data Integrity & Compliance APAC

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions 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.

Job Function:

Regulatory Affairs Group

Job Sub Function:

Regulatory Product Submissions and Registration

Job Category:

Professional

All Job Posting Locations:

Bangkok, Bangkok, Thailand, Singapore, Singapore

Job Description:

Johnson & Johnson Innovative Medicine Regional Regulatory Affairs is recruiting for a Manager, Regulatory Affairs Process Support, Data Integrity and Compliance in the Asia Pacific (APAC) region.

 

This role provides regional leadership in the Regulatory Affairs (RA) areas of process support, data integrity and compliance to the RA teams in the APAC region.

The role partners closely with regional and Local Operating Company (LOC) RA teams in APAC, as well as with cross-regional and global stakeholders in the GRA organization, to deliver sustainable solutions and support stakeholder needs. This role will also connect with relevant cross-functional partners in the region, e.g. Commercial Quality and Medical Safety for cross-functional alignment on process, data and compliance topics.

This role is a member of the Regulatory Affairs Process Support, Data Integrity and Compliance team within Cross-Regional Operations and Strategic Support (C-ROSS) and a key contributor to the team's success.

 

Key Responsibilities

Regulatory Affairs Process Support

• Provide strategic support and tactical advice to local and regional RA teams in APAC on optimal and compliant application of RA procedures and processes, including implementation of new regulatory requirements, systems and processes

• Facilitate APAC RA input into global/regional processes and procedures impacting APAC RA teams, partnering with assigned Subject Matter Experts (SMEs) as applicable

• Ensure, coordinate, develop and/or deliver (as needed) training and communication on RA processes for APAC, in collaboration with assigned business process owners and SMEs

• Identify and drive prioritized process improvement opportunities in APAC RA.

Regulatory Affairs Data Integrity

• Ensure robust tracking of agreed APAC RA data in global tracking systems and tools

• Provide guidance, trainings and communication to APAC RA teams on RA data tracking requirements in global systems

• Coordinate/provide APAC input on global RA data tracking systems, tools, requirements, projects and processes

• Provide support and advice to local and regional RA teams in APAC on efficient and compliant use of RA data systems and tools.

Regulatory Affairs Compliance

• Ensure the appropriate level of compliance in APAC RA

• Coordinate APAC RA contributions to global audits

• Provide support and coordination to APAC RA teams for LOC audits and inspections, as needed

• Act as the APAC RA contact for Global Regulatory Affairs (GRA) teams and other functions on RA compliance related topics and interpretation of local regulatory requirements

• Support and advise local and regional RA teams in APAC on procedural document related requirements as well as the maintenance, review and applicability of these documents

• Advise local and regional RA teams in APAC on management of non-conformances, CAPAs, quality or compliance issues, as needed.

Minimum Qualification

• At least 5 years of relevant experience in pharmaceutical industry and/or Health Authorities, including activities in a regulatory compliance or Good Practices (GxP) environment

• Excellent understanding of pharmaceutical Marketing Authorisation regulatory procedures and data in APAC countries

• Understanding of regulatory data planning and tracking processes as well as information systems

• Knowledge of RA compliance requirements and advanced process thinking

• Good technical skills and computer proficiency

• Proven ability to monitor multiple actions and timelines and follow up until timely completion

• Ability to work effectively in a matrix organisation with multiple cross-functional stakeholders on global, regional and local level

• Excellent cross-cultural interpersonal skills

• Ability to communicate effectively in English, verbally and in writing

• Flexibility and proactivity

• Team-player

 

 Other requirements

 

• Reachable during APAC office hours and outside office hours in case of emergencies

• Flexibility for limited travel (~5%)

 

This position is based in China, India, Japan, Malaysia, Singapore, South Korea or Thailand. Consideration can be given to applicants in other J&J locations in the APAC region.

 

Required Skills:

Preferred Skills:

Coaching, Compliance Management, Continuous Improvement, Design Thinking, Package and Labeling Regulations, Process Improvements, Product Packaging Design, Quality Assurance (QA), Regulatory Affairs Management, Regulatory Compliance, Standard Operating Procedure (SOP), Strategic Thinking, Sustainability, Sustainable Packaging, Technical Credibility, Transparency Reporting