Senior Regulatory Affairs Specialist
2 weeks ago
Position Summary
This role is pivotal in supporting the strategic development and execution of regulatory initiatives. Reporting directly to the VP of Global Regulatory Affairs, the incumbent will collaborate closely with cross-functional asset teams to prepare, review, and submit essential regulatory documentation, manage documentation systems, and maintain productive interactions with regulatory authorities.
Qualifications
• A Bachelor of Science in a relevant field is mandatory; an advanced degree in science is preferred.
• RAC certification or an equivalent credential is desirable.
Professional Experience
- A minimum of a Bachelor's degree in a scientific or related discipline, with over 5 years of experience in the pharmaceutical sector, including at least 3 years focused on regulatory CMC for US product development (essential).
- In-depth understanding of US and EU regulations pertaining to biosimilars is advantageous.
- Comprehensive knowledge of regulations governing drugs and biologics.
- Familiarity with GLP/GCP/GMP standards, clinical laboratory regulations, and licensing requirements.
- Proven experience in various regulatory submissions and effective communication with regulatory bodies.
- Experience in a multicultural and multinational environment is preferred.
Key Skills
- Fluency in both English and Chinese, encompassing both written and verbal communication.
- Proven ability to manage multiple diverse projects simultaneously.
- Ability to foster positive relationships and collaborations.
- Strong analytical capabilities; strategic thinker with planning and implementation skills.
- Capacity to work independently with minimal oversight.
- High proficiency in major Microsoft Office applications (e.g., Word, Excel, PowerPoint, Project).
- Demonstrates enthusiasm, integrity, fairness, and loyalty to the organization and its objectives.
Primary Responsibilities
- Contribute actively to the formulation of regulatory strategies for investigational products, including IND/CTA and BLA/MAA submissions, by assessing the scientific merits of CMC and nonclinical study data packages.
- Serve as the Global Product Strategy Lead within cross-functional teams, including contract research organizations (CROs), functional working groups, global regulatory teams, submission teams, and product development teams, ensuring adherence to regulatory standards.
- Draft Module 2 and 3 documents for regulatory submissions such as INDs, IMPDs, CTAs, MAAs, NDAs, global registrations, and eCTD submissions, ensuring compliance with current regulatory requirements.
- Oversee the preparation and review of regulatory submissions, including INDs, BLAs, MAAs, and meeting packages for ICH member Health Agencies, ensuring all documents are prepared according to guidelines and timelines.
- Manage and monitor submission dates, inquiries from Regulatory Health Authorities, responses, and approval timelines.
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