Regulatory Affairs Biosimilars Per Diem Consultant - Pharmavise Corporation : Job Details

Join to apply for the Regulatory Affairs Biosimilars Per Diem Consultant role at Pharmavise Corporation.

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 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 professionals to join as Regulatory Affairs Biosimilars Per Diem Consultants. Below are the responsibilities, qualifications, and expectations for this role:

• Provide expert regulatory guidance and support for biosimilars development projects.
• Review and analyze regulatory requirements and guidelines related to biosimilars across regions.
• Assist in preparing, submitting, and maintaining regulatory submissions such as INDs, BLAs, and variations.
• Collaborate with cross-functional teams to align on regulatory strategy and objectives.
• Stay updated on global regulatory developments and trends affecting biosimilars.
• Participate in meetings with regulatory authorities as needed.
• Support regulatory agency inspections and audits with expertise.

• Bachelor's degree in a scientific or related field; advanced degree preferred.
• At least 8 years of regulatory affairs experience in the pharmaceutical or biotech industry, with biosimilars expertise preferred.
• Strong knowledge of regulatory requirements for biosimilars development and approval.
• Experience with regulatory submissions including INDs, BLAs, and variations.
• Excellent communication skills and stakeholder collaboration ability.
• Ability to manage multiple projects independently.
• Regulatory affairs certification (RAC) is a plus.

This role offers a unique opportunity to leverage regulatory expertise on biologic medical products and impact the industry positively. Competitive compensation is available.

Pharmavise Consulting Corp. is an equal opportunity employer. We do not discriminate based on race, color, religion, sex, age, sexual orientation, gender identity, national origin, or other protected characteristics. Qualified applicants with criminal histories will be considered in accordance with applicable law. For accommodations during the application process, contact [email protected].

This is a remote position.

Pharmavise Consulting Corp. partners with clients in the Pharmaceutical, Medical Device, and Biotechnology sectors to provide compliance solutions. Join us to be part of a team that values Excellence Through Quality. Follow us on LinkedIn for updates and opportunities.

• Seniority level: Mid-Senior level
• Employment type: Contract
• Industry: Medical Equipment Manufacturing