Lead regulatory strategy and submissions (primarily CMC, also clinical and non-clinical) for investigational and marketed products. Serve as RA lead on cross-functional teams, liaise with FDA and other health authorities, drive regulatory due diligence, and implement policies to ensure timely approvals and compliance with ICH, FDA, and EU guidelines.
The Principal Regulatory Affairs (RA) Specialist, will manage and lead regulatory submissions and develop regulatory strategies for investigational and marketed products by interacting effectively within a cross-functional project team of internal and external subject matter experts. The scope of regulatory submissions will focus on CMC and will also include clinical and non-clinical submission. This position serves as the regulatory representative on relevant project teams and as the regulatory contact with health authorities.
- Actively understand and interpret industry trends and health authority's expectations in areas related to CMC, non-clinical and clinical. Influence and communicate how these trends align with strategic department direction and vision.
- Develop regulatory strategy for CMC, non-clinical, and clinical and define the corresponding submission deliverables for assigned development projects or programs and for post- approval changes and ensure implementation of agreed upon strategies.
- Provide technical and strategic direction on CMC, non-clinical and clinical issues throughout product development and commercialization.
- Monitor changes to development plans and provide regulatory guidance to teams
- Represent Regulatory Affairs at various project team and working group meetings.
- Act as a direct point of contact with FDA and participate in meetings for CMC, non-clinical and clinical issues.
- Collaborate with equivalent cross-functional colleagues concerning CMC, non-clinical and clinical interests to meet project milestones.
- Lead in regulatory due diligence activities as assigned.
- Act as a direct point of contact with FDA and participate in meetings for CMC, non-clinical and clinical related issues.
- Execute strategies to ensure rapid and timely approval of applications for new and marketed products.
- Maintain cross-functional awareness of and expertise in ICH, FDA and EU guidelines related to regulatory topics.
- Liaison with business partners on regulatory matters on assigned programs
- Collaborate with RA senior management to create and implement policies, processes, and procedures supporting the department goals and objectives.
Requirements:
A minimum of a Bachelor's degree in related science field and 9+ years of experience is required.
An advanced degree is preferred (minimum 7+ years with MS, minimum 4+ years with PhD).
Must have regulatory experience in the pharmaceutical industry, with experience in a multi-project environment.
The candidate must have proven ability to lead and work effectively in cross-functional teams.
Minimum of 3+ years of demonstrated leadership skills.
Other Knowledge, Skills, and Abilities:
- 505 b2 and generic experience along with managerial experience is preferred.
- Experience with international health authorities is preferred.
- Extensive knowledge of US CMC regulatory requirements and the ability to apply knowledge both strategically and operationally to development projects and marketed product regulatory issues.
- Comprehensive knowledge of drug development process, pharmaceutical technology, drug manufacturing processes and related issues, drug laws, regulations and guidelines.
- Comprehensive knowledge and experience in CMC sections for investigational and marketed product submissions for FDA. Must have strong strategic and critical thinking, leadership, diplomacy and negotiation skills.
- Excellent written and verbal communications skills.
- Must be able to effectively communicate with scientists at all levels.
- Demonstrated ability to work in and lead effectively in matrix teams.
- Strong organization and time management skills.
- Demonstrated ability to influence based on experience, facts and data.
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