Regulatory Affairs Biosimilars Per Diem Consultant

Pharmavise Corporation•Maple Grove, MN

15d•Remote

About The Position

From development to commercialization, we partner with Pharmaceutical, Medical Device and Biotechnology clients to provide solutions to complex compliance issues. We collaborate with our partners by providing technical expertise in Quality, Regulatory Compliance and Manufacturing Science and Technology. Our business mission is to ensure our clients exceed their compliance goals while improving patient health and safety. Visit us at www.pharmavise.com We are actively seeking skilled and knowledgeable 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.

Requirements

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.
Proven ability to work independently and manage multiple projects simultaneously.

Nice To Haves

Regulatory affairs certification (RAC) preferred but not required.

Responsibilities

Provide expert regulatory affairs guidance and support for biosimilars development projects.
Review and analyze 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.
Stay updated on regulatory developments and trends impacting biosimilars globally.
Participate in meetings with regulatory authorities as needed.
Provide regulatory support and expertise during regulatory agency inspections and audits.