Location: Baltimore,MD, USA
Responsibilities:
The Manager, Regulatory Affairs for Chemistry Manufacturing & Controls (CMC) works with internal and external partners in order to deliver products to patients.
Prepares CMC regulatory strategies that enable first pass approvals under limited management supervision.
Develops and manages content strategy for regulatory submissions, including INDs/CTAs and amendments, new market applications and supplements/variations with limited management supervision.
Builds and maintains relationships within the Regulatory Affairs functional areas and the Operations and Research & Development (R&D) organizations.
Represents RA CMC on product development and life-cycle management teams to negotiate, influence, and provide strategic advice to peers in RA, R&D, and Operations
The focus of this position is primarily biology products.
Prepares CMC regulatory product strategies with limited supervision.
Prepares regulatory submissions, including new applications and amendments, renewals, annual reports, supplements and variations under limited supervision 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 under limited supervision.
Develops strategies for CMC meetings, manages preparation for agency meetings and manages content of pre-meeting submissions under limited supervision.
Manages products and change control with an understanding of regulations and company policies and procedures with limited supervision.
Analyzes and approves manufacturing change requests with limited supervision.
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 the regulatory climate.
Analyzes legislation, regulation and guidance, and provides analysis to the organization under limited supervision.
Develops, implements, and documents policies and procedures within the regulatory affairs department under supervision of manager.
Requirements:
Bachelor's degree in pharmacy, biology, chemistry, pharmacology, engineering or related subject.
6 years pharmaceutical or industry related experience.
3-5 years in quality systems or cross-functional project management.
Experience working in a complex and matrix environment.
Strong oral and written communication skills.