8 months ago
Hamlyn Williams has partnered with an exciting company based in New Jersey, in their search for a Director of Regulatory Affairs.
Our client is seeking a candidate to lead the development of US and Global regulatory strategies from early development, through post approval. This role will partner with international team members to ensure successful execution of submissions, such as: INDs/CTAs/NDAs/MAAs and will lead interactions with global Health Authorities, such as the EMA, FDA and PMDA.
- Lead planning, execution and assessment of product life cycle management activities - from early development through post approval
- Proactively creating regulatory strategies
- Leading Health Authority interactions
- Identifying, monitoring and resolving regulatory issues and reporting progress to management
- Acting as the Global Regulatory Lead on International Project Teams, inputting into team discussion to ensure appropriate regulatory strategies are implemented
- Leading the Global Regulatory Subteam for assigned products, closely collaborating with nonclinical, CMC, growth market, and other regional regulatory leads on the overall strategy for a product
- Leading and coordinating all regulatory activities required for submissions to Health Authorities for assigned products
EDUCATION AND SKILLS REQUIREMENTS:
- Bachelor's degree in the sciences or health related fields, advanced degree preferred
- Minimum of 10 years of industry Regulatory Strategy experience required
- Experience with preparing IND/CTA/sNDA/Type II variation submissions and briefing packages for Healthy Authority meetings
- Experience with successful NDA, MAA and/or BLA filings preferred
- Strong understanding of pediatric development requirements globally
- Prior experience interacting with global Health Authorities is preferred, including leading Health Authority meetings
- The ability to work within and lead cross-functional team meetings and work streams
- Strong communication skills
- This role has the potential to manage a direct report based on business needs
- Approximately 10% travel based on business needs
Apply here or email email@example.com if you are interested in working with a leading organization in the industry.