Associate Director, Regulatory Affairs, South Asia

The Head of Regulatory Affairs for South Asia is responsible for actively contributing to the development and implementation of regulatory strategy for Alnylam’s entire portfolio including identifying and assessing regulatory risks, interfacing with Health Authorities, coordinating all aspects of regulatory submissions in China, Taiwan, South Korea, Hong Kong, Singapore, Australia and other countries of the regions and proactively keeping updated on regulatory requirements. The role requires an individual who very hands on and is able to work collaboratively across various expertise areas and is able to communicate effectively in a fast-paced environment.

The successful candidate will be at an Associate Director Level and will report to the Regulatory Affairs Senior Director, in Partner and Emerging Markets, and will be based in UK.

Summary of Key Responsibilities

• Oversee ALNYLAM compliance with Local Authorities regulations
• Support and oversee ALNYLAM’s distribution partner in the countries

• Identify potential regulatory risks to the strategic / operational plans and propose options to mitigate risks.
• Communicate plans, strategies and risks within the program team and Regulatory Affairs leadership and Senior Management in an effective manner.
• Lead negotiations with Health Authorities.
• Lead, prepare and submit timely marketing approvals and post approval variations in compliance with local market regulations.

• Review and interpret regulatory correspondences
• Communicate effectively with other ALNYLAM functions, consultants, companies, and health authorities
• Assure close coordination of pharmacovigilance, quality assurance, and other personnel responsible for duties involving manufacturing and marketing of ALNYLAM products
• Ensure compliance of ALNYLAM medical education and promotional materials with regulations and health authority guidance
• Remain current with evolving regulatory procedures and practices related to regulatory, quality, and safety reporting needs, and proactively guide ALNYLAM project teams
• Assist ALNYLAM project team members, and ALNYLAM’s partners in incorporating Local requirements into global product development strategies
• Accompany Health Authority inspections, when applicable, in manufacturing inspections related to GMP certifications

Mandatory Qualifications

• Science degree.
• Proven experience in Regulatory Affairs
• Strong knowledge of APAC regulatory requirements, and experience with development as well as marketed products, specifically including New Drug Applications
• Experience with Specialty Pharmaceuticals

• English communications skills including writing and delivering presentations to top management
• Adaptable and self-motivated, able to prioritize effectively with good problem solving and planning abilities.
• Demonstrate clear alignment with Alnylam Core Values including, Commitment to People, Innovation and Discovery, Sense of Urgency, Open Culture and Passion for Excellence.

Non-Mandatory, but desired qualifications

• Experience in rare disease

Successful candidate must

• Be comfortable in a multi-cultural environment
• Be enthusiastic about playing a key role in helping to build a new organization in different regions
• Be hands on, entrepreneurial and resourceful in working with a small staff to launch new products in the region
• Be able to travel and work on flexible hours