A Regulatory Affairs Manager plans, directs, or coordinates production activities of an organization to ensure compliance with regulations and standard operating procedures.
Login or Register Home Daily Jobs Post A Job Employers Create A Company Post A Free Job Post A Featured Job Search Resumes Job Seekers Dashboard Create A Resume Pricing Senior Corporate Counsel, Global TechOps & Phar... An American Biotechnology Corporation 20 hours ago South San Francisco, CA 7+ Years Full Time 202608-120925 203,800 - 378,400 / Yearly Not Specified Share on Apply now
Description:
The Position:
We are seeking to hire a Senior Corporate Counsel (Global TechOps & Pharma Quality) in Global Legal Technical Operations & Facilities. In this role you will focus on global support of our global Pharma Manufacturing unit and its sites, including regulatory and transactional counseling on FDA/cGMP, manufacturing supply and development agreements, and other related matters. Great medicine can't change the world if it never leaves the lab. Our Pharma Technical Operations (PT) organization is the global backbone that transforms scientific discoveries into real-world therapies. Joining our Global Legal Technical Operations & Facilities team means stepping onto a highly collaborative, global team of experts. Together, we provide the proactive legal support that empowers PT to manufacture and deliver medicines safely and efficiently. You'll be trusted to advise on complex, high-stakes matters, knowing that your daily work supports our patients and our company's global ambition to prevent, stop and cure diseases.
The Opportunity:
Key responsibilities of this role may include, but not be limited to, the following: Advising on global regulatory and compliance matters relating to FDA, EMA, or other global requirements for manufacturing compliance, regulatory enforcement actions, risk management, and commercial operations involving manufacturing practices—including Current Good Manufacturing Practices (cGMP), quality system requirements, and other quality-related issues and agreements. Partnering as lead counsel directly with the PT Global Head of Quality and PT Global Head of Regulatory to provide legal risk guidance on critical quality and regulatory matters, including quality governance structures, change control oversight, and significant compliance trends to prevent enforcement actions and protect product integrity worldwide. Providing strategic legal advice on US FDA facility inspections and foreign health authority inspection as well as internal GMP audits. Partnering with PT Quality organization to address critical quality issues, supply interruptions, manufacturing deviations, health authority notifications, and field actions. Advising the External Quality organization responsible for CMO and CDMO oversight to structure novel quality agreements and align on compliance standards for external manufacturing partners and supplier networks. Managing outside counsel retained to support legal matters.
The How:
Legal excellence accelerates in combination with the right business- and solutions-focused attitude, mindset, and ways of working. Here is who we are looking for: Communication and Leadership Pro-active and confident individual who is committed to driving change. Strong verbal and written communication skills. Ability to communicate complex and highly technical information clearly and concisely. Commitment to working as a team player in a multinational legal department. Excellent interpersonal skills with high cross-cultural sensitivity. Willingness to travel.
Our Expectations:
Strong business acumen; sensitive to business needs; views change as an opportunity; eager to work in a fast paced environment. Best in class attitude; challenges status quo constructively and contributes to improvements; results oriented; ability to influence; solutions oriented mindset.
Who You Are:
7+ years of experience with US FDA/cGMP in a pharma/biotech corporate setting and/or in a law firm or relevant government agency. A U.S. law degree (J.D.) and current "good standing" admission to at least one U.S. state bar, or be eligible to apply to California's Registered In-House Counsel program. Demonstrated experience and track record of success or committed interest in: Providing manufacturing support in pharmaceutical or biotech industries, such as regulatory counseling on FDA/cGMP related matters. Strong analytical, written, and oral communication skills in English; proficiency in additional European languages (e.g., German, French, Dutch) is a plus.
