Regulatory Affairs Biosimilars Per Diem Consultant

Pharmavise Corporation; United States; Remote; USD 120.000 - 180.000; Teilzeit

Benefits dieser Stelle

Competitive compensation

SME network access

Zusammenfassung

PharmaviseConsulting Corp. seeks a Regulatory Affairs Biosimilars Per Diem Consultant to guide regulatory programs from development through approval. You will review requirements, prepare submissions, and coordinate with cross-functional teams to align regulatory strategy.

The role demands a strong biosimilars background, experience with INDs/BLAs, and international guidelines, with 8+ years in regulatory affairs; RAC preferred. Remote contract position with competitive compensation.

Qualifikationen

• Bachelor's degree in a scientific field; advanced degree preferred.
• Minimum of 8 years of experience in regulatory affairs within the pharmaceutical/biotech industry, biosimilars preferred.
• RAC certification preferred but not required.
• Experience with regulatory submissions for biosimilars (INDs, BLAs, variations).

Aufgaben

• Provide expert regulatory affairs guidance for biosimilars development projects.
• Review and analyze regulatory requirements and guidelines for biosimilars globally.
• Assist in preparation, submission, and maintenance of regulatory submissions (INDs, BLAs, variations).
• Collaborate with cross-functional teams to align regulatory strategy and objectives.
• Stay updated on regulatory developments impacting biosimilars worldwide.
• Participate in meetings with regulatory authorities as needed.
• Provide regulatory support during inspections and audits.

Kenntnisse

Regulatory affairs

Biosimilars expertise

Regulatory submissions

Project management

Ausbildung

Bachelor's degree in science

Jobbeschreibung

This is a remote 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 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:

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.

Qualifications

• 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.
• Regulatory affairs certification (RAC) preferred but not required.

This is a unique opportunity for biosimilars consultant professionals to leverage their regulatory expertise onbiologic medical productsand make a meaningful impact in the pharmaceutical and medical device industries. Competitive compensation packages are available. Be part of our network of Subject Matter Experts.

EEO Employer: PharmaviseConsulting Corp. is an equal opportunity employer. We do not discriminate or allow discrimination on the basis of race, color, religion, creed, sex (including pregnancy, childbirth, breastfeeding, or related medical conditions), 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.PharmaviseConsulting Corp. will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law.

If you have visited our website in search of information on employment opportunities or to apply for a position, and you require accommodation in using our website for a search or application, please . PharmaviseConsulting Corp. is a regulatory compliance consulting firm that partners with Pharmaceutical, Medical Device and Biotechnology clients. When you joinPharmavise, you become part of a team that values Excellence Through Quality. Follow us in LinkedInfor more company updates and opportunities. Originally posted on Himalayas