SENIOR MANAGER, REGULATORY AFFAIRS-0090140716
Description
Role description:
Regulatory Affairs Medical Devices & Diagnostics (MD&D) Asia Pacific is establishing a new role within the region to support and accelerate the continued significant growth of the MD&D businesses.
We are looking for suitably qualified candidates who can together with the Regional Director, create and shape the regional Regulatory Affairs group to be a center of excellence that provides outstanding partnership with our local country Regulatory Affairs teams, regional Commercial leadership and regional Functions (such as Supply Chain, Medical Safety, Quality, Health Economics).
The major duties of the positions are:
- Proactively partner with the business in business strategic planning and provide innovative regulatory strategies and direction to the business. With regional business confirm the markets (“target markets”) the product/s are intended to be registered and sold. Translates the regulatory affairs portfolio strategy into executable plans.
- Expedites commercialization of new products in target markets by understanding regulatory requirements of these markets and incorporating these requirements early in the product development cycle through partnership with global franchise regulatory affairs
- Work with local country regulatory teams to develop regulatory strategies for New products (NPD/NPI) and assist them in product registration projects including planning, facilitating requests to global franchise regulatory affairs or R&D, monitoring the progress, status and timelines
- In partnership with regional business, develop life cycle management strategy for new and marketed products taking into consideration current and proposed regulatory changes, cost of maintenance (resource, financial and opportunity-cost) as well as new product pipeline
- Provides support directly or through global franchise Regulatory Affairs, to ensure that product variations, label changes and other potential product changes are identified, assessed by the impacted countries, and communicated to the global franchise regulatory affairs organization.
- Drive the closure of the change to communicate back to local markets, regional supply chain and business, the expected timeline and potential impact (such as the need to stock pile existing approved product)
- Understand regional and local regulatory requirements to support the local country regulatory teams in communicating the impact of new or changing regulatory requirements to the local business, supply chain and other function partners and elevate to regional business, regional supply chain and regional function partners as appropriate, as well as global franchise regulatory affairs; Drive and maximize the local and regional use of the regulatory documentation systems/database (PRIM powered by Trackwise) on regulatory status and requirements, license renewals and any product restrictions
- Thorough understanding of the role and impact partner function (such as Supply Chain, Quality, Health Economics and Reimbursement, and Medical Safety) decisions have on regulatory affairs activities and conversely the impact of regulatory decisions on these functions
- Manages regulatory interactions with local countries and serves as point of contact and regional expert for product portfolio; supports local country team in clarifying health authority questions and providing input to help expediting response to health authorities
- Works closely with local country regulatory teams to identify opportunities, and assists the local regulatory team in developing and implanting the regional policies to shape the local regulatory environment especially in markets that are developing or significantly changing
- Support and as appropriate participate in regional industry associations and health authority organizations such as AHWP, APEC
- Understands resource, time and expertise required to complete projects
- Provide mentoring and coaching of local regulatory teams as appropriate to strengthen and deepen Asia pacific RA talent
Qualifications
Qualifications
- Minimum of Bachelor’s degree or equivalent in pharmacy or life science or health related discipline
- At least 7 years regulatory experience with medical devices, pharmaceuticals or regulated consumer industry such as OTC medicines.
- Fluent in English, written and verbal; excellent communication skills. Ability to communicate to senior level management
- Hands on experience in medical device product registration in an Asia Pacific country, a familiarity with Asia Pacific regulatory systems and product registration requirements
- Demonstrated leadership and contribution; team player able to work in a virtual team environment whilst delivering as an individual contributor; Self-motivated and independent
- Culturally sensitive and able to work and thrive in a multicultural environment
- Ability to establish and maintain open relationships with internal and external stakeholders
- Demonstrated ability to handle multiple projects and strong organization skills
- Ability to influence without authority and operate within a matrix organization
- Ability to proactively sense and take action on problems and opportunities. The willingness to step in and act. Delivers business results and solutions whilst focused on Credo responsibilities.
- Some regional business travel (10-15%) and occasional international travel may be required.
- Must be able to work flexible hours to accommodate early morning/late evening meetings and teleconferences with different time zones.
Position Location:
Position is located in the Asia Pacific region within access of a J&J office. No relocation is provided so it is expected the successful candidate will work from home country.
Primary Location:Asia Pacific-Singapore-Singapore-Singapore
Organization: Johnson & Johnson Pte. Ltd. (8435)
Job Function: Regulatory Affairs
Description
Role description:
Regulatory Affairs Medical Devices & Diagnostics (MD&D) Asia Pacific is establishing a new role within the region to support and accelerate the continued significant growth of the MD&D businesses.
We are looking for suitably qualified candidates who can together with the Regional Director, create and shape the regional Regulatory Affairs group to be a center of excellence that provides outstanding partnership with our local country Regulatory Affairs teams, regional Commercial leadership and regional Functions (such as Supply Chain, Medical Safety, Quality, Health Economics).
The major duties of the positions are:
- Proactively partner with the business in business strategic planning and provide innovative regulatory strategies and direction to the business. With regional business confirm the markets (“target markets”) the product/s are intended to be registered and sold. Translates the regulatory affairs portfolio strategy into executable plans.
- Expedites commercialization of new products in target markets by understanding regulatory requirements of these markets and incorporating these requirements early in the product development cycle through partnership with global franchise regulatory affairs
- Work with local country regulatory teams to develop regulatory strategies for New products (NPD/NPI) and assist them in product registration projects including planning, facilitating requests to global franchise regulatory affairs or R&D, monitoring the progress, status and timelines
- In partnership with regional business, develop life cycle management strategy for new and marketed products taking into consideration current and proposed regulatory changes, cost of maintenance (resource, financial and opportunity-cost) as well as new product pipeline
- Provides support directly or through global franchise Regulatory Affairs, to ensure that product variations, label changes and other potential product changes are identified, assessed by the impacted countries, and communicated to the global franchise regulatory affairs organization.
- Drive the closure of the change to communicate back to local markets, regional supply chain and business, the expected timeline and potential impact (such as the need to stock pile existing approved product)
- Understand regional and local regulatory requirements to support the local country regulatory teams in communicating the impact of new or changing regulatory requirements to the local business, supply chain and other function partners and elevate to regional business, regional supply chain and regional function partners as appropriate, as well as global franchise regulatory affairs; Drive and maximize the local and regional use of the regulatory documentation systems/database (PRIM powered by Trackwise) on regulatory status and requirements, license renewals and any product restrictions
- Thorough understanding of the role and impact partner function (such as Supply Chain, Quality, Health Economics and Reimbursement, and Medical Safety) decisions have on regulatory affairs activities and conversely the impact of regulatory decisions on these functions
- Manages regulatory interactions with local countries and serves as point of contact and regional expert for product portfolio; supports local country team in clarifying health authority questions and providing input to help expediting response to health authorities
- Works closely with local country regulatory teams to identify opportunities, and assists the local regulatory team in developing and implanting the regional policies to shape the local regulatory environment especially in markets that are developing or significantly changing
- Support and as appropriate participate in regional industry associations and health authority organizations such as AHWP, APEC
- Understands resource, time and expertise required to complete projects
- Provide mentoring and coaching of local regulatory teams as appropriate to strengthen and deepen Asia pacific RA talent
Qualifications
Qualifications
- Minimum of Bachelor’s degree or equivalent in pharmacy or life science or health related discipline
- At least 7 years regulatory experience with medical devices, pharmaceuticals or regulated consumer industry such as OTC medicines.
- Fluent in English, written and verbal; excellent communication skills. Ability to communicate to senior level management
- Hands on experience in medical device product registration in an Asia Pacific country, a familiarity with Asia Pacific regulatory systems and product registration requirements
- Demonstrated leadership and contribution; team player able to work in a virtual team environment whilst delivering as an individual contributor; Self-motivated and independent
- Culturally sensitive and able to work and thrive in a multicultural environment
- Ability to establish and maintain open relationships with internal and external stakeholders
- Demonstrated ability to handle multiple projects and strong organization skills
- Ability to influence without authority and operate within a matrix organization
- Ability to proactively sense and take action on problems and opportunities. The willingness to step in and act. Delivers business results and solutions whilst focused on Credo responsibilities.
- Some regional business travel (10-15%) and occasional international travel may be required.
- Must be able to work flexible hours to accommodate early morning/late evening meetings and teleconferences with different time zones.
Position Location:
Position is located in the Asia Pacific region within access of a J&J office. No relocation is provided so it is expected the successful candidate will work from home country.
Primary Location:Asia Pacific-Singapore-Singapore-Singapore
Organization: Johnson & Johnson Pte. Ltd. (8435)
Job Function: Regulatory Affairs