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About the Role
The Associate Director Regulatory Affairs, Chemistry, Manufacturing and Controls (CMC) works with internal and external partners to deliver products to patients. Prepares CMC regulatory strategies that enable first pass approvals. Develops and manages content strategy for regulatory submissions, including INDs/CTAs and amendments, new marketing applications and supplements/variations. Builds and maintains relationships within the Regulatory Affairs functional areas, Operations and Research & Development (R&D) organizations. Represents CMC on teams such as product development, Global Regulatory Product Teams and Operations brand teams to negotiate, influence, and provide strategic advice. Serves as strategic liaison with the regulatory agencies (e.g., FDA) regarding CMC matters.
Responsibilities
- Prepares CMC regulatory product strategies.
- Prepares and manages regulatory submissions, including new applications and amendments, renewals annual reports, supplements and variations and responds to regulatory information.
- Analyzes and interprets information that impacts regulatory decisions.
- Seeks expert advice and technical support as required for strategies and submissions.
- Reviews and revises regulatory submissions to effectively present data and strategy to regulatory agencies.
- Develops strategies for CMC agency meetings, manages preparation for agency meetings, and manages content of pre-meeting submissions.
- Serves as the point of contact for the regulatory agency meetings.
- Manages products and change control with an understanding of regulations and company policies and procedures.
- Analyzes and approves manufacturing change requests.
- Represents CMC regulatory affairs on teams such as the product development, Global Regulatory Product Teams and Operations brand teams, for assigned projects.
- Negotiates with and influences team members with support of management to maximize chances for first pass approval of regulatory submissions.
- Stays abreast of regulatory procedures and changes in regulatory climate.
- Analyzes legislation, regulation and guidance, provides analysis to the organization.
- Develops, implements, and documents policies and procedures within the regulatory affairs department.
- Leads initiatives internal to RA CMC.
- Represents CMC regulatory affairs on project initiatives with other functional areas to drive efficiencies across the company.
- Trains, develops and mentors individuals; may include formal supervisory responsibilities.
Requirements
- Experience developing and implementing successful global regulatory strategies.
- Experience working with Health Authority.
- Experience working in a complex and matrix environment.
- Strong oral and written communication skills.
Experience Level
- 8 years pharmaceutical with at least 3 years of demonstrated leadership
- 10 years pharmaceutical experience including 5-plus years in regulatory affairs or 5-plus years in Discovery, R&D, or Manufacturing.
Education Level
- Bachelor’s Degree in Pharmacy, Chemistry, Biology or Pharmacology, Engineering or related subject.
- Relevant advanced degree preferred.
- Certification a plus.
Salary/Compensations
- USD 141500 - USD 268500 - yearly
Benefits
- Comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees.
- Eligible to participate in our long-term incentive programs.
About the Company
- AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow.
- We strive to have a remarkable impact on people's lives across several key therapeutic areas including immunology, oncology and neuroscience - and products and services in our Allergan Aesthetics portfolio.
- For more information about AbbVie, please visit us at www.abbvie.com.
- Follow @abbvie on LinkedIn, Facebook, Instagram, X and YouTube.
Equal Opportunity
- AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community.
- Equal Opportunity Employer/Veterans/Disabled.
- US & Puerto Rico only - to learn more, visit https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html
- US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more: https://www.abbvie.com/join-us/reasonable-accommodations.html