Compliance Supervisor leading Quality & Compliance programs at Apotex, overseeing audits and ensuring compliance with regulatory requirements in pharmaceutical manufacturing.
About the role
- Director leading regulatory policy research and operations at Johnson & Johnson. Accountable for scientific research coordination and regulatory intelligence oversight with a hybrid work model.
Responsibilities
- Lead and coordinate scientific research support for GRA and GRPI policy positions and initiatives.
- Oversee the regulatory intelligence function, ensuring timely and relevant insights.
- Conduct or coordinate research for various outputs including publications, presentations, and policy positions.
- Support the policy team’s coverage of trade association policy activities and other external policy groups.
- Create and implement tools and strategies to develop and align policy priorities, strategic plans, and other policy documents.
- Manage GRPI efforts related to commenting programs, developing and submitting company perspectives.
- Support the Head GRPI with functional governance activities including strategy and goal setting.
- Oversee the GRPI website and related tools.
- Provide project management, process, and change leadership for GRPI-driven initiatives.
- Supervise a small team responsible for regulatory intelligence, communications, and operational support for GRPI.
- Work with cross-functional leaders and partners to advance policy initiatives.
Requirements
- A minimum of a Bachelor’s degree in a scientific or technical discipline is required.
- An advanced degree (Master’s, PharmD, Ph.D.) in a scientific or technical discipline is preferred.
- A minimum of 10 years of experience in the pharmaceutical industry or Contract Research Organization (CRO) is required.
- A minimum of 4 years of experience in Regulatory Affairs or with Regulatory Policy is required.
- A minimum of 4 years of direct people management experience is required.
- Experience working at a major health authority (e.g., FDA) is preferred.
- Solid understanding of the global regulatory environment, including the U.S., European Union and Asia Pacific, is preferred.
- Understanding of global regulatory systems is preferred.
- Knowledge of healthcare policy landscapes is preferred.
- Experience with digital health and/or artificial intelligence (AI) is preferred.
- Strong computer skills, with the ability to work with programs such as Smartsheet and SharePoint, required.
- Must have excellent oral and written communication skills.
- Must have strong negotiation and stakeholder management skills.
- The ability to lead cross-functional initiatives and influence decision-making in a matrixed organization.
Benefits
- medical
- dental
- vision
- life insurance
- short- and long-term disability
- business accident insurance
- group legal insurance
- consolidated retirement plan (pension)
- savings plan (401(k))
- Vacation - up to 120 hours per calendar year
- Sick time - up to 40 hours per calendar year
- Holiday pay, including Floating Holidays - up to 13 days per calendar year
- Work, Personal and Family Time - up to 40 hours per calendar year
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