Description
The Regulatory Affairs Manager provides Regulatory strategy and direction from product concept to launch through the product lifecycle, with emphasis on OTC drug products, homeopathic products but also supporting other products such as cosmetics as assigned. Provides subject matter expertise on OTC drug products and homeopathic products; advises and guides the regional and global cross-functional teams on regulatory requirements for market introduction and maintenance. Provides technical mentorship to junior team members within and outside Global Regulatory Affairs. Serves as a lead technical interface for the department. Acts a key liaison between the Company and regulatory approval authorities (e.g., US FDA).
Manager Responsibilities
- Lead product development initiatives from conception, through development, evaluation, pre-launch, launch, and post-launch.
- Identify regulatory requirements and optional pathways to market.
- Provide regulatory information, guidance and strategy for product development and planning throughout the product lifecycle.
- Evaluate regulatory impact of proposed changes to marketed products and communicate clear actions.
- Monitor and communicate regulatory intelligence to assist in the development of business and compliance plans.
- Provide regulatory information and guidance for proposed product claims and labeling. Approve product artwork and promotional materials.
- Lead process improvement projects to streamline current activities and increase department efficiencies, including the update, enhancement, creation and implementation of new internal policies and procedures. Assist other departments to develop SOPs as needed to ensure regulatory compliance.
- Simplify regulatory information and help train stakeholders on current and new regulatory requirements to ensure organization-wide compliance.
- Represent Regulatory function in external and internal inspections (FDA).
- Ensure all assigned records to support inspections are established, maintained and documented.
- Perform other duties as assigned.
- May have direct reports.
Qualifications, knowledge, training or experience required for the post
- Bachelor’s or Master’s degree in a scientific discipline or equivalent is required.
- Minimum 8 years regulatory experience, with at least 5 years technical experience in assessing regulatory suitability of OTC drug and homeopathic products for the US market, including development of label/artwork and review of advertising/marketing claims.
- Experience in managing and supporting other FDA-regulated products such as cosmetics or dietary supplements is a plus.
- Excellent influence, persuasion, verbal and written communication skills.
- Excellent organizational, planning, and follow-up skills. Must have ability to meet tight deadlines and be efficient, detail oriented, flexible, and a self-starter.
- Individuals must demonstrate the ability to collaborate successfully in a dynamic and culturally diverse workplace.
- Ability to consistently deliver quality work in a high-pressure environment.
- Excellence in solving complex problems, project strategy, execution, and collaboration skills.
- Comfort and skill to work in fast-paced environment, independently and without much assistance from management team.
