Regulatory Biosimilar Consultant Expert
4 days ago
This is a remote position with competitive compensation packages available.
Pharmavise Consulting Corp. is a regulatory compliance consulting firm that partners with Pharmaceutical, Medical Device and Biotechnology clients. Our business mission is to ensure our clients exceed their compliance goals while improving patient health and safety.
We are actively seeking skilled professionals to join our team as Regulatory Affairs Biosimilars Per Diem Consultants. Below, you'll find a comprehensive job description detailing the responsibilities, qualifications, and expectations for this role:
Responsibilities- Provide expert guidance on regulatory affairs and support for biosimilars development projects, including reviewing and analyzing regulatory requirements and guidelines related to biosimilars in various regions.
- Assist in the preparation, submission, and maintenance of regulatory submissions for biosimilars, including INDs, BLAs, and variations.
- Collaborate with cross-functional teams to ensure alignment on regulatory strategy and objectives, staying updated on regulatory developments and trends impacting biosimilars globally.
- Participate in meetings with regulatory authorities as needed, providing regulatory support and expertise during regulatory agency inspections and audits.
- Bachelor's degree in a scientific or related field; advanced degree preferred.
- Minimum of 8 years of experience in regulatory affairs within the pharmaceutical or biotechnology industry, with specific expertise in biosimilars preferred.
- Strong understanding of regulatory requirements and guidelines governing biosimilars development and approval processes.
- Experience with regulatory submissions for biosimilars, including INDs, BLAs, and variations.
- Excellent communication and interpersonal skills, with the ability to effectively collaborate with internal and external stakeholders.
This is an opportunity to leverage your regulatory expertise on biologic medical products and make a meaningful impact in the pharmaceutical and medical device industries.
We offer competitive compensation packages, EEO Employer: Pharmavise Consulting Corp. is an equal opportunity employer. We do not discriminate or allow discrimination on the basis of race, color, religion, creed, sex, age, sexual orientation, gender identity, national origin, ancestry, citizenship, genetic information, registered domestic partner status, marital status, disability, status as a crime victim, protected veteran status, political affiliation, union membership, or any other characteristic protected by law.
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