Manager – Business Development, Operations & Regulatory Affairs - Manila

Company: Surgeway Biosciences Philippines Inc. – Ortigas, Pasig City

About Surgeway:

Surgeway is a global pharmaceutical exports company specializing in high-quality, affordable generic and branded products across therapeutic areas. We operate in over 10 countries with a strong presence in Asia and Africa.

At Surgeway, we’re not just building a business — we’re shaping the future of health access across borders. You’ll be working in a fast-paced, mission-driven environment with a passionate, global team.

Job Summary:

We are seeking a dynamic and versatile professional, who will kick start our operations, and be an integral part of our operations in the Philippines.

He/she will oversee business development, regulatory affairs, and operations. The ideal candidate will have strong experience in the pharmaceutical or medical device industry, with proven ability to manage market expansion, ensure regulatory compliance, and optimize operational efficiency.

WE ARE LOOKING FOR A LEADER WITH AN OWNERSHIP MINDSET, HAVING HIGH INTEGRITY, WHO CAN WORK INDEPENDENTLY WITHOUT A LOT OF SUPERVISION (JUST CLARITY OF VISION)

Key Responsibilities:

• Working with our incorporation consultants and their law firm – to quicken up the processes regarding permits and clearances – and expedite the process
• Working with our LTO and FDA Philippines consultant – to quicken up the processes of LTO formation.
• Working with the local banks, for swift opening of bank accounts.
• All other department related work, so we can be up and running in the shortest time.
• Identification of specific category of products – Supplements/Medical Devices/Cosmetics - that we can launch in the shortest time possible, to break even quickly
• Identification of pharmaceutical drugs – so we can work on getting CLIDPs or file for PCPRs

• Identify and manage new business opportunities (RFQ/RFI, proposals, presentations).
• Lead product development from pricing and registration to launch.
• Build and manage distributor and client relationships.
• Conduct market research and monitor sales performance.
• Train and support local sales teams and partners.

• Oversee FDA product registration, renewals, and compliance documentation.
• Ensure timely and accurate submission of regulatory filings.
• Liaise with local and international regulatory bodies.
• Manage documentation for government bids and product safety reporting.

• Supervise daily operations and ensure adherence to SOPs and local regulations.
• Oversee inventory, order management, and quality assurance systems.
• Address product complaints, adverse events, and internal audits.
• Support continuous process improvement and team training.

Qualifications:

• Licensed Pharmacist or graduate in Life Sciences (preferred).
• 5 - 10 years of relevant experience in pharma or healthcare.
• Strong knowledge of Philippine FDA processes and compliance.
• Excellent leadership, communication, and cross-functional management skills.