Director of Regulatory Affairs – Remote Jobs
Job Description
Job Name: Director of Regulatory Affairs
Name of the Company: BeiGene
Location: Remote (US)
Salary range: Not mentioned
Job Type: Full-time Employee
Career Level: Senior Level Manager
Education Level: Bachelor’s/ Undergraduate Degree
Categories: Medical & Health
Travel Required: Yes, up to 20%
Position Description
BeiGene, a rapidly growing company, is seeking a Director of Regulatory Affairs to develop, advise, and implement global regulatory strategies for development programs to secure market access of the product(s) in compliance with business objectives. Reporting to senior management, the Director will oversee regulatory aspects of all product development stages and provide strategic regulatory guidance safeguarding the company’s interests in external interactions with regulatory agencies and business partners.
Responsibilities
The Director of Regulatory Affairs will be responsible for:
● Providing high-level regulatory strategic direction and mentorship for clinical trials and marketing approval of domestic and foreign markets while considering regulatory requirements.
● Ensuring the timely submission of regulatory packages and documentation globally to support the investigational and marketing registration process.
● Reviewing and verifying sections of submission documents, including IND/CTA, NDA/MAA in line with local regulatory needs.
● Liaising and negotiating with global regulatory authorities for drug development aspects, including expedited approvals, labeling changes, and resolution of issues.
● Keeping updated on regulatory changes and their effect on the business and product development programs.
● Developing and leading a team of regulatory professionals via direct or indirect channels to ensure corporate goals are met.
Qualifications
The ideal candidate would possess the following qualifications:
● A Bachelor’s degree, and an advanced degree is preferred.
● At least 10+ years of experience in the biotechnical or pharmaceutical industry, with five years of minimum experience in a Regulatory capacity with a broad background.
● Working experience with Regulatory Affairs across two or more major geographic areas and small molecules or biologics.
● Wide-ranging knowledge of regulatory requirements and policy trends governing drug development processes in the pharmaceutical industry.
● Demonstrated experience with INDs/CTAs, NDAs/BLAs/MAAs, lifecycle management, and interaction with Health Authorities.
● Strong strategic business skills, problem-solving abilities and excellent communication expertise.
● Strong negotiation and conflict resolution skills and able to think outside of the box.
● Exceptional multi-tasking and prioritization ability with a proven ability to navigate complexity and ambiguity.
● Ability to work seamlessly with teams, internal and external stakeholders, partners, and clients.
This is an excellent opportunity to work with an established global biotech company providing opportunities for personal and professional growth.
