Senior Director, Associate General Counsel, Global Regulatory Compliance (58802)
Teva Pharmaceutical Industries See More Job Openings by This Employer
The Sr. Director, Associate General Counsel, Global Regulatory Compliance role reports directly to the VP, Chief Regulatory Counsel. This position will provide primary legal support for GxP quality, compliance, investigation, and enforcement activities, worldwide.
This role counsels clients on a wide range of regulatory compliance issues with a focus on current good manufacturing practices (GMP), good clinical practice (GCP), and good laboratory practice (GLP) and quality processes related to the research, development, manufacturing, and distribution of innovative, biosimilar, and generic pharmaceuticals around the world. The attorney will work collaboratively with cross-functional teams to develop, lead, and implement communications with global regulators, including responses to health authority inspections and inquiries, and on remediation and corrective action plans. The attorney will prepare and provide policies, trainings, and updates to management (and, occasionally, larger audiences) on developing legal matters, GxP best practices, and similar matters.
This role will collaborate with attorneys and other professionals inside and outside of the U.S., including outside counsel, who possess certain subject matter expertise to ensure all legal matters are assessed and handled capably.
This role can be based in the West Chester, PA or the Parsippany, NJ locations. Hybrid schedule - 3 days on-site and 2 days remote.
- Counsel clients on a wide range of regulatory compliance issues with a focus on current GxP practices and quality processes related to the research, development, manufacture, and distribution of innovative, biosimilar, and generic pharmaceuticals, worldwide.
- Work collaboratively with cross-functional teams to develop, lead, and implement communications with global regulators, including responses to health authority inspections and inquiries, and on remediation and corrective action plans.
- Participate in internal meetings to review quality metrics, participate in site or project governance committees, and facilitate internal audits.
- Partner with Compliance to provide legal support for internal investigations.
- Work cross-functionally with Quality, Regulatory, and other stakeholders to support process and system improvements, including development of global quality policies and training materials.
- Monitor and participate in the external policy environment and advise teams on policy and regulatory developments related to GxP activities.
- Manage a legal budget and ensure alignment with financial targets.
- Manage outside counsel who provide services in support of this role.
- Provide trainings to management and employees on emerging and/or hot legal topics.
- A Juris Doctor (JD) degree from a top tier law school is required.
- A minimum of 8 years prior experience at law firm and/or in-house legal department is required.
- Legal experience working within manufacturing and/or R&D quality is required.
- Admission to practice law in the bar of a relevant jurisdiction/ability to be house counsel.
- Demonstrated excellence in (i) understanding complex scenarios in order to identify and evaluate relevant issues and risks; (ii) proposing solutions that take into consideration the relevant business objectives; and (iii) communicating those issues, risks, and solutions clearly and concisely.
- Strong interpersonal skills and an ability to work collaboratively, with a solution-oriented approach, in global, cross-functional teams within legal, compliance, business, and other functional areas.
- Strong relationship-building skills, able to influence internal and external stakeholders. This individual will be highly visible at all levels of the organization and must be able to build trust and credibility.
- Strong foundation of analytical skills, verbal, and written communication skills.
- Strong organizational skills and an ability to handle multiple responsibilities simultaneously and still meet quality and timeliness standards under pressure.
- Self-motivation, an ability to work proactively and independently, reliability, responsiveness, and accountability.
- Intellectual curiosity, with a commitment to continuous learning and improvement.
- Sound judgment, commitment to ethical conduct, and a high level of professionalism.
- Up to 25% travel, including international, as needed.
We offer a competitive benefits package, including:
- Comprehensive Health Insurance: Medical, Dental, Vision, and Prescription coverage starting on the first day of employment, providing the employee enrolls.
- Retirement Savings: 401(k) with employer match, up to 6% and an annual 3.75% Defined Contribution to the 401k plan.
- Time Off: Paid Time Off including vacation, sick/safe time, caretaker time, 13 paid Holidays and 3 paid floating holidays.
- Life and Disability Protection: Company paid Life and Disability insurance.
- Additional benefits include, but not limited to, Employee Assistance Program, Employee Stock Purchase Plan, Tuition Assistance, Flexible Spending Accounts, Health Savings Account, Life Style Spending Account, Volunteer Time Off, Paid Parental Leave, if eligible , Family Building Benefits, Virtual Physical Therapy, Accident, Critical Illness and Hospital Indemnity Insurances, Identity Theft Protection, Legal Plan, Voluntary Life Insurance and Long Term Disability and more.
If you are a current Teva employee, please apply using the internal career site available on "Employee Central". By doing so, your application will be treated with priority. You will also be able to see opportunities that are open exclusively to Teva employees. Use the following link to search and apply: Internal Career Site
The internal career site is available from your home network as well. If you have trouble accessing your EC account, please contact your local HR/IT partner.
Teva Pharmaceuticals is committed to equal opportunity in employment. It is Teva's global policy that equal employment opportunity be provided without regard to age, race, creed, color, religion, sex, disability, pregnancy, medical condition, sexual orientation, gender identity or expression, ancestry, veteran status, national or ethnic origin or any other legally recognized status entitled to protection under applicable laws. We are committed to a diverse and inclusive workplace for all. If you are contacted for a job opportunity, please advise us of any accommodations needed to support you throughout the recruitment and selection process. All accommodation information provided will be treated as confidential and used only for the purpose of providing an accessible candidate experience.
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Teva Pharmaceuticals USA does not accept unsolicited assistance from agencies for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.
