Come join a company that tackles fascinating problems and find solutions to complex challenges. With deep expertise in influenza science, our team works on cutting-edge research, pioneering technologies to optimise the manufacturing process and improve the effectiveness of influenza vaccines. We operate as one integrated global organisation, drawing together expert staff from different countries to collaborate. Together, we are working on the front line to protect communities from seasonal influenza and global pandemic threats. When you join Seqirus, you join a team dedicated to making a difference in people's lives. It's a feeling of possibility, creativity, and purpose that inspires us every day.
The Regulatory Affairs Manager, Advertising & Promotion is responsible for providing strategic and operational leadership in the area of advertising and promotion primarily pertaining to US marketing activities and products within the influenza vaccines portfolio.
This role will report to the Senior Manager Global Strategic Labelling and will review promotional materials to assess for compliance with the applicable regulations and guidance documents. The successful candidate must be capable of representing the commercial regulatory perspective at the promotional material review forum which includes cross functional partners from Commercial/Marketing, Medical Affairs, and Legal. This role may also serve as the company's regulatory liaison to the FDA Office of Prescription Drug Promotion (OPDP) (formerly DDMAC) and will help ensure materials are submitted to FDA in a timely manner.
Responsibilities include: -
- Independently manage the review and approval of promotional materials for Seqirus marketed products.
- Provide regulatory leadership and guidance to the marketing team during the development, review and approval of product labelling and advertising materials by working directly with the marketing team from concept through review and approval, up to and including OPDP submissions
- Monitor industry changes relating to advertising and promotion, interpret new Guidance to Industry, and continue efforts to evaluate processes within Regulatory Affairs relating to the promotion of Seqirus products in the United States.
- Responsible for coordinating preparation, compilation and submission of high-quality applications of promotional materials to FDA OPDP
- Point of contact with FDA Office of Prescription Drug Promotion
- Actively contribute to the global Seqirus regulatory community through designated projects
Skills, Qualifications & Competencies: -
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- Effective delivery of objectives in a complex matrix environment
- Ability to deal with rapid change
- Effective verbal & written communication skills in a cross functional environment
- Attention to detail
- Excellent project management skills
- Proactively owns and drives assigned tasks to completion
- Proactively develops solutions and maximises opportunities ahead of time
- Develops effective contingency plans
- Strong negotiation skills with internal and external stakeholders
- Extensive and proactive commercial awareness with evidenced application to regulatory strategies
- Excellent customer focus with demonstrated management of customer expectations and anticipating customer needs
- Demonstrated ability to take measured risks with overall positive outcome for the business
- Excellent presentation skills
- A degree in Biological Science, Allied Medical discipline or Pharmacy;
- preferably with a Masters or PhD, or complementary experience in the
- pharmaceutical/ biotechnology industry.
- 7+ years' regulatory experience with specific regulatory knowledge and
- experience US promotional materials and advertising.
Seqirus is an Equal Opportunity Employer