Regulatory Affairs Manager
- Bachelors degree in life science, relevant scientific field (e.g. pharmacology, toxicology, chemistry)
- 8+ years of experience in relevant Regulatory Affairs experience
- Direct experience working within regulatory affairs for NHP, OTC, DIN, medicinal products and/or devices or cosmetics with Health Canada
- Strategic thinker, creative problem solving, analysis, investigative, risk mitigation and decision making skills required
- Strong business acumen and marketing savvy
- Strong multi-tasking, prioritizing and organizational skills required
- Proven ability to mentor, coach and develop regulatory staff
- Excellent verbal, written, presentation and organization skills; strong negotiation and proven ability to influence
- Experience of working flexibly across a portfolio of products
Our Consumer Healthcare Regulatory Affairs Team wants you!
We are a science-led global healthcare company with a mission: we want to help people to do more, feel better, live longer. The consumer healthcare products that we research and develop can improve people's health and well-being, ultimately helping them to live life to its fullest and contribute to the prosperity of their communities.
Our consumer healthcare products have a heritage that goes back more than 160 years, producing some of the world's best-loved healthcare brands including: Sensodyne, Pronamel, Voltaren, Buckley's, Neocitran and TUMS.
- The Manager, Regulatory Affairs works autonomously to oversee day-to-day Regulatory Affairs activities for specific area(s) of responsibility.
- Interacts with regulatory agency personnel in order to seek guidance, expedite approval of pending applications and to resolve regulatory matters.
- Manages functional activities to ensure both short and long term department and company objectives are met.
- Understands the regulatory landscape across an assigned area of business. Monitors the regulatory environment and provides assessments of the impact of new and changing regulations on the company's areas of interest.
- Provides assessments and data to execute plans to address sensitive, competitive and PR type issues.
- Manages compliance within the department by ensuring global, regional and local processes, policies, SOPs and working instructions are adhered to.
- Manages updates to relevant global, regional and local databases to ensure compliance
- Plans, conducts and manages the coordination and compilation of regulatory submissions, responses to regulatory agencies questions and other correspondence in accordance with regulatory agency regulations and guidelines.
- Develops, translates, reviews (if relevant) and approves artwork and promotional copy to ensure regulatory compliance for submissions.
- Uses available electronic publishing tools to compile, electronic or paper based submissions necessary to meet regulatory requirements.
- Monitors progress of applications of self/direct reports against set timelines, taking action where necessary to minimise delays and anticipate difficulties.
- Provides executive summaries and status updates on product/project activities to key internal/external stakeholders.
- Contributes to the development regulatory strategies and identifies gaps that may impact implementation within their area of responsibility.
- May represent GSK and provide regulatory advice at e.g. joint company/trade association initiatives, regulatory agency meetings etc (as appropriate).
- Oversees or initiates development of best practices for Regulatory Affairs processes.
- Provides technical guidance and solutions to complex problems in which data analysis requires an evaluation of intangible variables.
- Maintains and archives regulatory documentation (as appropriate).
- Ensures quality and compliance in all actions.
- Partners with the business to deliver regulatory outcomes to enable committed business
- Works with strategic direction to performs with independent judgment and execution which directly impacts the operational results of the business unit.
- Represents Regulatory Affairs on cross-functional product/project teams and provides regulatory advice.
- Manages work groups and provides direction.
- Applies organizational understanding and awareness in decision making.
- Uses effective communication and employs influencing skills to continue to grow key relationships with internal/external contacts.
- May provide training on key regulatory legislation, systems, processes and/or projects (as appropriate).
GSK is an equal opportunity employer committed to diversity and inclusion. We welcome applications from all qualified individuals. GSK is committed to accommodating persons with disabilities. If you need accommodation at any stage of the application process or want more information on our accommodation policies, please contact us at [email protected]
You may apply for this position online by selecting the Apply now button.
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