- As local regulatory lead, represent Regulatory Affairs (RA) in assigned project meetings and provide regulatory guidance as appropriate, and for preparation of regulatory documents.
- Serve as an internal expert in International RA by providing strategic and operational guidance to management and project teams for the international registration of new products or new indications, especially for the US, EU, and Australia, including:
- Providing interpretation regarding regulations and advice on interactions with agencies (FDA, EU, etc.) and their guidance requirements.
- Monitor and anticipate changes in regulatory and access environments that might impact company portfolio programs and provide timely advice to management and project teams.
- Identify and assess regulatory risks, mitigations, and contingencies.
- Support China product RA lead or indication RA lead to prepare and review meeting requests and briefing documents; responsible for submission and follow up with the review and responses to requests from regulatory agencies.
- Work with RemeGen China product RA lead or indication RA lead to plan, prepare, and review submissions to regulatory agencies, to support RA submission approval. Ensure all documents and communications with regulatory agencies are timely, accurate, complete, verifiable, and in compliance with agencies' requirements.
- Responsible for organizing FDA communication meetings to ensure meeting quality.
- Responsible for managing CRO depending on project assignment.
- Responsible for the preparation, review, and submission of ODD documents in the U.S. and Europe.
- Liaison with health authorities as needed.
- Archive management for related projects, sending to China's central archiving.
- BS in a science related field, required.
- Advanced training in medical or life sciences is a plus.
- 10+ years of relevant regulatory/industry experience in both biotech or pharmaceuticals.
- At least 8 years as the Global Regulatory Affairs lead representative on project development teams that have led to marketing authorization.
- Must have experience supporting clinical development teams in the autoimmune space.
- Scientific, technical, and developmental background in large molecular drug development is highly desired.
- Experience from IND through to BLA, across all disciplines (nonclinical, clinical, CMC), as well as attending/running regulatory interactions.
- Knowledge and understanding of autoimmune disease biology and translational research is required.
- Recognize concept of "one registration" and recognize the differences in responsibilities between Headquarters and local teams.
- Excellent written and verbal communication skills.
- Ability to work cross-functionally in a fast-paced, collaborative environment.
- Strong attention to detail and problem-solving skills.
- 401(k) and matching program
- Medical, Vision, and Dental Insurance
- Flexible Spending Account
- Short- and long-term disability
- Life insurance
- Employee Assistance Program
- Employee discounts
- Paid time off/vacation/sick time
- Professional development assistance
- Referral program
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Global Director of Regulatory Affairs - South San Francisco, United States - Remegen Biosciences, Inc.
Description
Job Description
Job DescriptionORGANIZATIONRemeGen Biosciences is a biopharmaceutical company, focusing on the discovery and development of innovative medicines for the treatment of cancer and autoimmune diseases, based in South San Francisco, California, and Rockville, Maryland. By leveraging our deep insights into oncology and immunology, advanced protein engineering/design technologies, and extensive knowledge in clinical development, our vision is to uncover the novel therapeutic targets and develop the best-in-class and first-in-class biotherapeutics for the patients with significant unmet medical needs. RemeGen Biosciences is a wholly owned subsidiary of RemeGen Co., Ltd a global pharmaceutical company specialized in autoimmune, oncology and ophthalmic diseases.
POSITION SUMMARY
The Director of Global Regulatory Affairs will serve as a pivotal member of the organization, overseeing regulatory strategies and operations, particularly for product registrations and indications in international markets, with a focus on the US, EU, Australia, and China. This role will be the local regulatory lead and internal expert for the Autoimmune Clinical Development team, providing regulatory guidance to cross-functional project teams, ensuring compliance with international regulations, assessing regulatory risks, and engaging with health authorities. With a strong scientific and technical background in large molecular drug-development, the Director will strategically manage interactions with regulatory agencies, optimize project submissions, and maintain vigilant awareness of evolving regulatory landscapes. This is a remote position for candidates located in Massachusetts, Pennsylvania, South Carolina, and Texas.
KEY RESPONSIBILITIES
REQUIREMENTS
Education:
OTHER
Supervisory Responsibilities:None.
Equipment To Be Used:Laptop computer, other office equipment, and/or lab equipment.
Typical Physical Demands:Manual dexterity sufficient to operate standard office equipment.
Working Conditions:Works remotely. Occasionally called upon to work hours in excess of your normal daily schedule. Travel as needed.
BENEFITS
Benefits:
RemeGen Biosciences is an Equal Opportunity Employer. RemeGen Biosciences' success depends heavily on the effective utilization of qualified people, regardless of their race, ancestry, religion, color, sex, age, national origin, sexual orientation, gender identity and/or expression, disability, veteran's status, or any other characteristic protected by the law. As a company, we adhere to and promote equal employment opportunity (EEO) for all.
Must be able to work legally in the United States without sponsorship from employer.
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