- Development and oversight of CMC strategy and risk assessments, ensuring compliance with U.S. and international regulatory requirements, including working on protocol and experimental designs.
- Review, approval, and release of the CMC section of a high-volume of development and maintenance regulatory submissions. Support of drug substance and drug product dossiers are required. Submissions are recognized as high quality as demonstrated by limited review rounds and minimal Health Authority questions (FDA CVM, APVMA, CVMP, VDD), and one-pass approvability.
- Work closely with Manufacturing to resolve complex CMC issues and to support process changes.
- Develop, recommend, and communicate strategic direction and best possible regulatory position to achieve desired outcomes.
- Effective review, approval, and release procedures assure that submissions are of the highest quality while meeting current Health Authority regulatory expectations and business needs according to defined timelines.
- Interact and strategically negotiate with representatives from Regulatory Agencies to assure that appropriate and pragmatic positions can be negotiated with the highest probability of success.
- Responsible for development of strategy and risk assessments for CMC activities. Assures that, for major CMC activities that have a critical regulatory and/or financial impact, appropriate strategies are developed to manage the activities and risks are identified, communicated, and mitigated as necessary.
- Maintains the expertise and positive image of CMC expert in an evolving regulatory environment.
- Develops excellent working relationships with internal regulatory and external functional partners; including, vendors, partners, and collaborators.
- Review of product labelling, advertisement, and marketing related product materials. Oversight of labelling development and/or changes with graphics vendors and/or CMOs. Prepare submissions and listings of labelling materials for FDA.
- Work with team to establish department infrastructure and procedures for pre and post approval regulatory functions for veterinary pharmaceuticals.
- B.S. degree in chemistry, Animal Science, Life Science, Agriculture, or related field required.
- 3 – 5 years pharmaceutical regulatory experience desired.
- Experience within the animal health pharmaceutical industry is desired.
- Strong knowledge of the US FDA CVM guidance's is required.
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Regulatory Affairs Associate - Overland Park, United States - Parnell Veterinary Pharmaceuticals
2 weeks ago
Description
Who We Are
Parnell Veterinary Pharmaceuticals is a global animal health company based in Overland Park, KS with a focus on innovation and rapid growth. Our unique digital technologies integrate with our innovative products to provide veterinarians, producers and pet parents with unique solutions for their animal health needs. We offer personal and professional development opportunities for those who demonstrate the company's core values of Professionalism, Excellence, and Teamwork, and an exciting, fast-paced and entrepreneurial work environment.
We are seeking a Regulatory Affairs Associate to join our team The primary responsibility of the Regulatory Affairs Associate will be Regulatory and Chemistry, Manufacturing, and Controls (CMC) development activities in support of U.S. and ex-U.S. regulatory filings (e.g. INAD, NADA, ANADA) for both internal projects and with partners/alliances. This position provides development and CMC strategy and risk assessments. The incumbent will manage interactions and strategic negotiations with regulatory agencies and partners. This role will ensure US pharmacovigilance compliance with clinic follow-up and ADE reporting.
The incumbent will possess the skills to lead and collaborate effectively across the company, to align the broader Parnell organization to ensure compliance with the regulation guidance. The Regulatory Affairs department works as one team effectively collaborating with the Executive Leadership Team, Manufacturing, Quality Assurance, New Product Introduction, Commercial Operations, and Marketing to deliver our vision of being a growth-oriented, trusted and reliable resource, delivering innovative solutions to our customers' success.
Responsibilities
Qualifications
Education:
Professional:
The competitive remuneration package includes;
• 41 days PTO each year (22 x Vacation, 10 x Personal, 9 x Public Holidays)
• Quarterly Bonuses
• Annual Bonus
• A top-tier company funded Healthcare program
• 401K, immediately vested with a 4% match
