Regulatory And Product Manager (Wfh Flexi 20hrs/Week, Sexual Healthcare Social Enterprise) ID-3069
Job Summary:
Join a long standing social enterprise advancing regional sexual healthcare and HIV prevention for communities at risk. We are seeking an experienced contract Regulatory and Product Manager, with a passion for Busiess development, to join our team on a flexi-hour work-from-home basis (less than 10 days a month) with a view of long term employment.
The role provides a chance for the successful candidate to own product development pharmaceuticals and related services,.end to end product ownership from conceptualisation, development, market research and entry , patent analysis and licensing/permits where applicable and sourcing and working with Sales partners and distributors to bring the product to shelf and sales.
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The successful candidate will be responsible for managing the regulatory affairs and product development/management and entry plus distribution for the company's pharmaceutical products and services in Singapore, Korea, Japan, and Taiwan , where we are the authorised agent with the Thailand Government Pharmaceutical Organisation (Thai GPO).
In addition, the role will lead regulatory issues, drive government initiatives including grants applications and management, busineas and product development and partnerships.
Key Responsibilities:
Regulatory Affairs:
Ensure compliance with all applicable regulatory requirements in Singapore, Korea, Japan, and Taiwan
Prepare and submit patent analysis, product dossiers, variations, and notifications for registration and approval
Resolve Regulatory challenges and gaps when facing approval roadblocks and courage to overcome them creatively or strategic negotiation
Track submissions and completions to ensure timely approvals
Address regulatory issues related to product sales and distribution
Maintain current product licenses and registration documents
Liaise with company lawyers and Thailand GPO for regulatory matters
Product Management:
Conduct regional market research for product and service market entry
Develop and execute product launch plans and product assets and operational such as brochure/factsheets for distributors and consumer and operational workflows.
Manage relationships with sourced distributors, sales agents and key accounts in-market
Monitor product lifecycle and resolve any issues together with partners
Business Development:
Explore government-related grants and funding opportunities
Identify and pursue strategic partnerships to expand market reach and revenue
Drive existing product performance and new Business opportunities/products/services
Qualifications:
Preferably Bachelor's degree or higher in a relevant field, such as pharmaceuticals, regulatory affairs with Sales or business development experience
MUST have Minimum of 2 year of experience in pharmaceuticals licensing/permits submissions and regulatory affairs outside Singapore
Experience in bringing new pharmaceutical products and services into a market through business development, sales, and management of regulatory and distribution agents
Strong knowledge of pharmaceuticals regulatory requirements in Singapore, Korea, Japan, and Taiwan and proficiency in a second language other than English in our target markets advantageous
Entrepreneurial in problem solving along with business acumen
Capable of being both independent and a team player
Excellent communication and interpersonal skills
Ability to work independently and as part of a team
Proficient in Microsoft Office applications
