Manager and Director Regulatory Affairs
Our Client is a specialty pharmaceutical company that is developing innovative technologies to treat diseases and disorders of the skin and subcutaneous tissue, leveraging intellectual property and therapeutic applications that will result in market-leading products.
This posting is for a Director of Regulatory Affairs - Development and Marketed Products. There is a separate position available for a Senior Manager Regulatory Affairs--Marketed Products, who serves as a member of the Promotional Review Committee (PRC)A, collaborates with originators and cross functional teams in the development of new promotional campaigns and reviews supporting materials ensuring compliance and consistency with internal policies, and is responsible for regulatory activities for commercial products including review and submission of advertising and promotional materials.
The Director of Regulatory Affairs - Development and Marketed Products directs all regulatory activities for new and existing products to ensure alignment and compliance with FDA laws and guidances and local regulatory requirements, as well as company policies. This role will develop and oversee the implementation of regulatory strategies in support of the Company’s development and marketed product programs. Additionally, this position will provide regulatory direction and support to ensure compliance in areas of advertising, promotion labeling, Chemistry, Manufacturing and Controls (CMC), and other activities related to the commercialization of US marketed products.
- Formulate, communicate and implement regulatory strategy for assigned programs to meet regulatory requirements and achieve established project milestones and Corporate objectives.
- Support regulatory activities from development through post-approval, including; interfacing with regulatory authorities, preparation of regulatory documentation, critical review of regulatory dossiers and query response strategies and execution; oversight of labeling processes for marketed products; and oversight of regulatory guidance, review and submission of advertising and promotional materials.
- Ensure that all plans and activities for and on behalf of the company are carried out with the "best" industry practices and the highest ethical standards.
- Direct labeling activities for the NDA’ d products including development of processes and policies for labeling review and approval as well as drug listing and establishment registrations. In addition, provide regulatory advice and participate in labeling negotiations with agencies resulting in product approvals or labeling updates.
- Develop and/or revise SOPs, policies, and guidelines to ensure compliance with newly issued or revised regulations and guidance documents.
- Represent Regulatory function to cross-functional program teams and sub-teams to communicate Regulatory position and drive Regulatory deliverables.
- Primary liaison with Food and Drug Administration (FDA), CLS’ Project Managers and Review Teams for CLS products.
- Perform regulatory intelligence due diligence activities for potential business opportunities and other duties as assigned by the VP of Regulatory and QA.
- Oversees the preparation of regulatory filings.
- Bachelor and/or Advanced Degree in a scientific field with twelve (12) plus years in a Regulatory Affairs function within the pharmaceutical industry. CMC experience preferred.
Skills and Knowledge:
- Demonstrated ability to work both independently and as a part of a team.
- Experience interacting with the FDA—dermatology would be a plus.
- Demonstrated ability to work cross-functionally, with various levels in the organization and internationally.
- Strong collaboration and leadership skills.
- Proficient knowledge of technical support writing, cGMP's and FDA regulations is required.
- Excellent communication, interpersonal and influencing skills.
- Proficient in writing regulatory submissions for new drugs (i.e. IND’s, NDA’s) and ensuring that submissions meet ICH and FDA guidelines.
- Proficient with eCTD submissions to FDA.
- Vendor management experience.
- Demonstrated ability to manage multiple projects.
- Understanding and sensitivity to multi-cultural environment.
- Experience managing and developing subordinates.