Regulatory Affairs and Product Manager (Long-term WFH 10days / month)

Employment Type : Remote WFH Flexi Hour Role (20 hours per week or 10 days per month)

Minimum Duration : 1 year with view to permanent position

Salary : Starting from SGD 1250 (proportional to expected commitment and working hours)

Separate CPF Contributions Apply

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 business 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 conceptualization, 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.

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 authorized 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, business and product development and partnerships.

Key Responsibilities :

1. Regulatory Affairs :

Ensure compliance with all applicable regulatory requirements in Singapore, Korea, Japan, and Taiwan

1. Prepare and submit patent analysis, product dossiers, variations, and notifications for registration and approval
2. Resolve regulatory challenges and gaps when facing approval roadblocks and courage to overcome them creatively or strategic negotiation
3. Track submissions and completions to ensure timely approvals
4. Address regulatory issues related to product sales and distribution
5. Maintain current product licenses and registration documents
6. Liaise with company lawyers and Thailand GPO for regulatory matters

1. Product Management :

Conduct regional market research for product and service market entry

1. Develop and execute product launch plans and product assets and operational workflows such as brochures / factsheets for distributors and consumers
2. Manage relationships with sourced distributors, sales agents, and key accounts in-market
3. Monitor product lifecycle and resolve any issues together with partners

1. Business Development :

Explore government-related grants and funding opportunities

1. Identify and pursue strategic partnerships to expand market reach and revenue
2. Drive existing product performance and new business opportunities / products / services

Qualifications :

1. Preferably Bachelor's degree or higher in a relevant field, such as pharmaceuticals, regulatory affairs with sales or business development experience
2. MUST have a minimum of 2 years of experience in pharmaceuticals licensing / permits submissions and regulatory affairs outside Singapore
3. Experience in bringing new pharmaceutical products and services into a market through business development, sales, and management of regulatory and distribution agents
4. Strong knowledge of pharmaceuticals regulatory requirements in Singapore, Korea, Japan, and Taiwan; proficiency in a second language other than English in our target markets is advantageous
5. Entrepreneurial in problem-solving along with business acumen
6. Capable of being both independent and a team player
7. Excellent communication and interpersonal skills
8. Ability to work independently and as part of a team
9. Proficient in Microsoft Office applications

Additional Information :

1. Flexible working hours of less than 3 days a week
2. Team and individual bonuses including incentives for each market product entry launched
3. Ability to work from any desired location as part of our regional remote team member
4. Separate CPF contributions apply
5. Candidates may seek other employment or have current jobs, where allowed by their companies

To Apply :

Interested candidates are invited to submit their resume and a cover letter to recruitment@prepsingapore.com