Corporate Counsel, Global Legal Technical Operations & Facilities

Roche•South San Francisco, CA

46d•$181,800 - $337,600•Onsite

About The Position

This role focuses on global support to Pharma Technical Operations (PT) and its sites, involving regulatory and transactional counseling on environmental, health & safety matters, FDA/cGMP, manufacturing supply and development agreements, and other related matters. The individual will provide legal advice and strategic counseling to PT sites, Environmental Health and Safety (EHS) departments, global EHS functions, and other business units. They will advise and represent manufacturing sites on EHS compliance and enforcement matters, sustainability, and environmental land use issues. This includes coordinating environmental due diligence, drafting and negotiating EHS and related provisions of contracts, and counseling on environmental site remediation. Additionally, the role involves advising on regulatory and compliance matters under the Federal Food, Drug, and Cosmetic Act related to manufacturing practices (cGMP), quality system requirements, and other issues and agreements involving quality considerations. The Corporate Counsel will also prepare and negotiate manufacturing supply and development agreements, advise on related transactional issues key to manufacturing operations, and manage outside counsel.

Requirements

5+ years of EHS or manufacturing related legal experience, ideally 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 EHS regulatory compliance advice to industrial clients, preferably to the pharmaceutical or biotech industries.
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.

Nice To Haves

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.
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.

Responsibilities

Providing legal advice and strategic counseling to PT sites, Environmental Health and Safety (EHS) departments, global EHS functions, and other business units.
Advising and representing our manufacturing sites on EHS compliance and enforcement matters, sustainability, and environmental land use issues.
Coordinating environmental due diligence; drafting and negotiating EHS and related provisions of contracts; and counseling on environmental site remediation.
Advising on regulatory and compliance matters arising under the Federal Food, Drug, and Cosmetic Act related to manufacturing practices (cGMP), quality system requirements, and other issues and agreements involving quality considerations.
Preparing and negotiating manufacturing supply and development agreements, and advising on related transactional issues key to manufacturing operations.
Managing outside counsel retained to support legal matters.