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Principal Consultant, CMC

US

About Opus Regulatory:
For more than 30 years, Opus Regulatory has provided strategic guidance to industry partners through expert consultants in key practice areas: Regulatory Strategy, CMC, Labeling, Ad Promo, Medical Review, and Medical Information. Our team of senior-level leaders and innovators provides project-specific contributions or ongoing support through the regulatory process. Opus provides customized solutions to meet the challenges and restrictions faced by our clients - from startup biotechs to mid-to-large size pharmaceutical companies. 

The Principal Consultant, Regulatory Affairs CMC will primarily be responsible for the daily management of regulatory requirements for one or more clients, designing and implementing submission strategy, and developing and maintaining relationships with key client staff and regulatory authorities. We have a robust client portfolio offering a variety of projects including therapeutic areas.

 

Responsibilities include:

  • Supports the regulatory function on assigned development/commercial programs providing CMC regulatory guidance and strategy including identifying and assessing regulatory risks 
  • Provide high-level strategy input on critical regulatory filing documents (e.g., meeting packages/briefing books (FDA Interact, pre-INDs, Type A, B, C, D), scientific advice, INDs, IMPDs, BLAs, MAAs, NDAs, annual reports, DSUR, amendments, supplements) to facilitate and expedite the development, licensure, and marketing of drugs and/or biologics. Perform final review and approval for all global submissions for the portfolio to ensure alignment with program regulatory strategy and development plan.   
  • Provide oversight for interactions with global regulatory authorities (e.g., meetings, IR responses, inspections).   
  • Lead and facilitate preparation for meetings with FDA and other regulatory authorities for CMC development activities 
  • Experience in authoring complex technical documents and CMC regulatory CTD (M2 and M3) sections
  • Proactively identify program issues and develop appropriate regulatory strategies to mitigate risks 
  • Perform RA-CMC compliance activities
  • Monitor emerging legislation and guidance in the CMC field and contribute to ensuring company-level awareness and compliance (where appropriate). 

 

Qualifications

  • Minimum experience: A minimum of 7 years’ pharmaceutical/biotech industry experience.
  • Minimum of 5 years of relevant regulatory affairs CMC experience in the areas of gene therapies, small and large molecules (biologics), vaccines, and/or combination of products/devices.
  • Minimum education: Bachelor’s degree (advanced degree in a science discipline preferred). 
  • Extensive regulatory affairs knowledge and familiarity with regulatory affairs best practices 
  • Substantial project management skill, with a demonstrated ability in planning, implementing, and executing tasks to meet RA goals. 
  • Regulatory submission knowledge, including eCTD and NDA/IND requirements. 
  • Steadfast attention to detail; ability to identify and communicate methods for improving existing processes. 
  • Ability to work in a dynamic pharmaceutical environment. 
  • Ability to work collaboratively and direct the work of others toward common goals. 

 

Opus Regulatory is an Equal Opportunity Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.

Opus is committed to providing benefit-eligible employees with a comprehensive benefits package designed to support your health, financial well-being, and work-life balance. We offer medical, dental, vision, and prescription drug coverage for employees and their eligible family members. Additional benefits include Life Insurance, Short-Term Disability (STD), and an Employee Assistance Program (EAP), a 401(k) plan, and more. To support time away from work, we provide a paid time off package, which includes 20 vacation days, 5 sick days, & 10 paid company holidays annually.

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