Description:

Every day, we rise to the challenge to make a difference and here's how the Counsel, Regulatory Compliance role will make an impact:
Key responsibilities for this role include:

Responsible for counseling clients on a wide range of regulatory compliance issues with focus on GxP and Quality processes for the development, manufacture, and distribution of drugs, biologics, medical devices, supplements, and cosmetics.
This position works collaboratively with cross-functional teams to develop communications with regulators, including responses to health authority inspections and inquiries, and post-marketing reports.
Provide timely and effective counsel related to compliance with GxP regulations from various health authorities (e.g., FDA, EMA, TGA, Health Canada, WHO).
Assist with development of corrective action plans and responses following regulatory inspections and inquiries.
Assist in developing materials for regulatory meetings and preparing teams participating in such meetings.
Participate in committee meetings to review internal quality metrics and participate in site or project governance committees, as needed.
Provide guidance on product quality incidents and post-marketing reporting obligations and actions.
Work cross functionally with Quality, Regulatory, and other stakeholders to advise on and support process and systems improvements, including development of global quality policies and training materials.
Prepare and edit written reports and communications for internal and external use related to regulatory and GxP compliance requirements and obligations.
Monitor the external environment and advise teams on policy and regulatory developments related to GxP and related activities.
Manage engagements with outside counsel to ensure effective and efficient use.
Perform related duties as assigned.

The minimum qualifications for this role are:

Juris Doctorate is required and 7 years of experience in Pharmaceutical or biotechnology industry as inside or outside counsel. Three to five years of technical expertise in manufacturing and GxP auditing preferred. Related experience/education may also be considered.
Seven years of Legal experience advising clients directly or under the supervision of lawyers.
Licensed to practice law in one or more jurisdictions is required.
Exceptional oral and written communication skills, including strong presentation capabilities.
Strong interpersonal and conflict resolution skills.
Ability to work in a collaborative, team-oriented environment.
Background/education in science related discipline is preferred.
This role may have remote flexibility.
Proficiency in speaking, comprehending, reading and writing English is required.