Regulatory Consultant - CMC
Parexel International Corporation
USA - Any Region - Home Based
Parexel's Regulatory Consulting team continues to grow! We are currently looking for experienced CMC Regulatory Affairs professionals who are passionate about drug development and committed to making a difference!
This is truly a fantastic opportunity to join Parexel’s highly recognized Regulatory Consulting Services Team as a Consultant and work alongside some of the most respected Thought Leaders in the Industry!
As a CMC Consultant, you will be responsible for working with various clients: Authoring high quality CMC documents including, regulatory authority requests for information, meeting briefing books, meeting minutes, IND/IMPD/CTA submissions, NDA/MAA/BLA submissions, and DMFs while assuring all documents meet regulatory requirements and quality compliance. Preparing for Health Authority Meetings and attending these meetings as needed Assisting in the preparation of responses to HA questions on pre and post-approval activities Participating in strategic regulatory advice discussions with regards to pre- and post-marketing issues to clients Conducting due diligence and gap analysis of existing products, and advising on remediation activities Developing and maintaining excellent relationships with internal cross-functional groups and Parexel clients As needed, the Consultant may be asked to provide Regulatory Affairs Generalist support to clients by providing assistance with insight into forms required and/or specific section requirements for HA submissions The Consultant may be asked to serve as a US Agent for international clients QualificationsDesirable Skills:
• High-level consulting skills
• Critical thinking and problem-solving skills
• Project leadership and management knowledge
• Excellent interpersonal and intercultural communication skills, both written and verbal
• Client-focused approach to work
• Results orientation
• Teamwork and collaboration skills
Qualifications: Minimum of a Bachelor’s Degree, Advanced Degree preferable in Biochemistry, Biotechnology, Molecular- or Cell Biology, or have comparable experience in research 5-7+ years relevant experience in the pharmaceutical industry in roles such as Product Development, Manufacturing, Quality or Regulatory Affairs CMC with direct experience in authoring relevant sections of Heath Authority Applications to include INDs, NDAs, and/or BLAs. Previous Regulatory CMC experience in small or large molecules and or vaccines or biologics with extensive experience in preparing documentation for regulatory authorities. Demonstrated ability to author and deliver high quality regulatory documents. Thorough understanding of drug development process and the pharmaceutical industry and healthcare environment including regulatory requirements, guidelines, and market and policy trends. Strong written and oral communication skills; comfortable communicating with and building relationships with various stakeholders including external partners and regulatory authorities. Previous experience interacting with a regulatory agency (such as FDA, MHRA) is a plus Knowledge of a variety of dosages forms is a plus. Up to 30% domestic or international travel may be required in the future when travel restrictions are lifted and it is sage to do so EEO DisclaimerParexel is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to legally protected status, which in the US includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.