Are you a skilled Regulatory Affairs Manager with experience in combination products seeking your next career move in Chicago? We're excited to offer a direct placement opportunity for our client!
Responsibilities
- Lead Quality and Regulatory Services Initiatives: Manage aspects of combination product programs and projects, coordinating with both internal teams and external clients to achieve defined outcomes.
- Collaborate Across Functions: Partner with teams in Sales, Marketing, R&D, Human Factors, Risk Management, Quality, and Regulatory to integrate customer requirements and streamline development and submission processes.
- Support and Knowledge Sharing: Mobilize support from internal experts to enhance project management, quality, and regulatory. Ensure comprehensive service offerings to pharmaceutical partners.
- Align Objectives: Ensure customer needs are met in alignment with our client's strategic objectives, maintaining active involvement of internal stakeholders.
- Provide Expert Guidance: Educate and guide customers on drug delivery systems, quality, and regulatory requirements.
- Enhance Industry Understanding: Keep abreast of industry developments and combination products through regular participation in conferences and trade shows.
- Maintain Compliance Documentation:
- Ability to author, review, and approve clear and concise quality and regulatory documents
- Oversee regulatory documentation related to combination products to ensure compliance.
- Agencies Relationship: Be the point of contact between the company and the regulatory agency – serve as the regulatory liaison.
- Effective Communication and Relationship Building: Articulate Quality and Regulatory services benefits to pharmaceutical clients and build lasting relationships with key industry leaders.
Qualifications
- 8+ years of experience with a Bachelor of Science degree, in a related scientific discipline, or 5+ years of experience with a higher-level degree
- Expertise in development and commercial product lifecycle (Design Control or Clinical Phase 1-3, Marketed combination products).
- Prior success in filing marketing applications, supplements, and variations for biologic products within timelines is required, and global submission experience is desired.
- A thorough understanding of IND, BLA, NDA, MAA, and combination product processes such as Notified Body Opinion.
- Strong knowledge of US and international GMP quality regulations, current industry practices, and experience with interpretation and application to development projects and marketed combination product regulatory issues.
- Demonstrated experience in effective collaboration with multiple stakeholders both internally and externally including customers, FDA, and other Health Authorities.
- Demonstrated ability to coach, train, and mentor teams.
- Strong negotiating skills and ability to think creatively and develop creative solutions.
- Ability to prioritize and handle multiple projects simultaneously.
- Excellent interpersonal, oral, and written communication skills as well as strong organizational skills with demonstrated ability to manage and adhere to timelines.
- Proven ability to build trust and respect within the organization and external partners.
Location
- Chicago, IL - Hybrid (Three days onsite, two days remote)
- There is a travel requirement of up to 30%
Employment Type
About Ventura Solutions
Ventura Solutions is a reputable end-to-end medical device and combination product consulting, staffing, and training firm. With our deep industry expertise spanning medical devices and combination products, coupled with an outstanding talent pool, we stand out as the preferred option for a diverse array of projects. On the consulting side, we integrate seamlessly into your team and manage small to complex Statement of Work (SOW) projects. On the staffing side, we help source, screen, and on-board reputable employees to fill temporary, temp to permanent, and permanent job openings. We accelerate product development, keep products compliant, and help build great organizations. For more information, visit us at www.ventura-solutions.com.
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