Associate Director Reguatory Affairs
Associate Director Reguatory Affairs
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Salary Not Disclosed
1 Vacancy
Job Description
Job Description
Location: New Jersey
Job Title: Associated Director Regulatory Affairs
We are seeking an experienced and highly motivated Associate Director Regulatory Affairs to support our expanding portfolio in the oncology area. This is an exciting opportunity to play a critical role in regulatory strategy and compliance for a fastgrowing organization.
Key Responsibilities:
- Develop and implement regulatory strategies for chemical and biological modalities to support clinical development and product registration in the US and globally.
- Lead regulatory submission activities including PreIND IND NDA/BLA and other lifecycle management filings.
- Ensure the preparation and delivery of highquality regulatory documents.
- Drive Health Authority interactions including preparing briefing books coordinating rehearsals and developing risk mitigation plans.
- Collaborate crossfunctionally to align regulatory activities with program goals and timelines.
- Maintain expert knowledge of FDA EMA and ICH guidelines and the evolving regulatory landscape.
- Ensure compliance with regulatory requirements and support auditing/inspections.
- Provide regulatory leadership to internal teams and external partners.
Qualifications:
- Bachelors degree in a relevant scientific field (e.g. Chemistry Biochemistry Molecular Biology Biotechnology Biology Pharmacy); advanced degree preferred.
- Minimum of 5 years of regulatory affairs experience in pharmaceutical clinical development.
- Strong expertise in FDA EMA and ICH regulatory guidelines and processes.
- Proven track record of successful regulatory milestones in product development and registrations.
- Experience in direct communication and negotiations with regulatory agencies.
- Strong organizational skills with meticulous attention to detail.
- Excellent communication and leadership skills with a proactive approach.
- Ability to work independently and collaboratively within a dynamic environment.
- Flexibility to accommodate working across global time zones including some evening meetings.
- Proficiency in English; Mandarin language skills are a plus.
If you are a resultsdriven regulatory professional looking for an opportunity to make a significant impact we encourage you to apply today!
To apply:
Direct line:
#LIHybrid
#LIKW3
Required Experience:
Director
Employment Type
Full-Time
