Regulatory Affairs Manager

The Company

iNova is a different kind of health company. We are leading the way to better health by delivering innovative, patient-centric products that improve the lives of people around the world. Our diverse portfolio of iconic, market-leading consumer health brands and prescription medicines are backed by science and distributed in over 75 markets across Asia, Australia, New Zealand, Middle East & Africa and Europe. Experience the iNova difference today.

The Opportunity

We currently have an opportunity for a Regulatory Affairs Manager to join our Regulatory Affairs team on a full-time basis.

Reporting to Japan Country Lead & Head of Compliance (Sokatsu), the position is responsible for setting & executing the Japan regulatory strategy, managing product registration and maintenance, local regulatory support for the new product launch and local activities in Japan.

Key accountabilities and performance indicators include:

Regulatory Affairs (Yakuji)

Submission of regulatory application documents of products & obtaining approvals

• Write, obtain, and maintain approvals for the Japanese market and plan the strategy.
• Plan submission schedule and monitor the status.
• Prepare import/reimbursement application documents and maintains the approvals.
• Collect information of new product under development.
  

Managing post registration changes including regulatory submissions

• Collect and assesses product change information to take necessary actions.
• Submit and obtains approvals of product variations to ensure up to date product compliance

RA Document control & regulatory intelligence

• Monitor and interpret updates to the Pharmaceutical and Medical Device Act (PMD Act) and related regulatory notices issued by MHLW and PMDA. Assesses their impact on iNova’s products and operations in Japan, provides strategic regulatory guidance, and implements appropriate risk mitigation measures
• Collect information directly from the industry to secure company’s benefits.
  

Support Innovation, BD and Commercial Expansion Projects

• Support successful outcomes for innovation, BD activities and major commercial expansion projects by supporting regulatory due diligence, and the collation and dissemination of technical information including dossiers, product lists, formulations, and artworks
  

Education and training for development.

Other projects

• Always support the local & global team whenever necessary.
• Other global, local and ad-hoc projects may be assigned.

Qualifications:

• Bachelor’s Degree required.
• Pharmacist License welcomed but not required.
• Minimum 6 years of experience in regulatory affairs management in the pharmaceutical industry in Japan.
• Minimum of 2 years of people management experience and good pharmacological/ pharmaceutical/ clinical knowledge.

Skills & Experience

• Pharmacy, medical or relevant science degree with good pharmacological/ pharmaceutical chemistry/ clinical knowledge (Essential)
• Deep understanding of relevant regulatory requirements for medicines, medical devices, health foods, dietary supplements, cosmetics and veterinary medicines (Desirable)
• Familiar with fundamental principles of clinical, regulatory, registration and compliance issues in Japan and how those regulations impact on the development, introduction, manufacture, quality, registration and marketing of iNova’s products
• Strong project planning and organisational skills and a high degree of multi-project tasking; ability to handle multiple projects within an active and wide range of health care products
• Understanding of matrix organisational issue and ability to communicate to multiple stakeholders to facilitate achievement of key strategic objectives
• Demonstrated strong interpersonal, communication and influencing skills
• Demonstrated leadership skills; proven decision-maker, hands-on and action-oriented style
• Native level Japanese language and business level English required.

Personal Attributes

• Ability to work effectively within a team in a fast-paced environment
• Establish good working relationship with both internal and external parties
• Demonstrate ability to handle multiple projects
• Strong organizational, planning and follow-up skills
• Good IT skill is an added advantage but not mandatory
• Proficient in Microsoft Office
• High level of attention to details and accuracy
• Strong communication skills (both oral and written) and time-management skills
• Able to interact with internal and external stakeholders in a professional manner
• Self-motivated, able to prioritize, multi-task and meets deadline in a timely manner
• Positive, proactive attitude and a keen learner
• Proven track record of developing people with specific focus on ambition and passion
• High capability in delivering results among strategy changes and transformations
• Decisive, self-motivated