Senior Manager for Regulatory Affairs
Senior Manager for Regulatory Affairs

Senior Manager for Regulatory Affairs

Weston-super-Mare Full-Time 43200 - 72000 £ / year (est.) No home office possible
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At a Glance

  • Tasks: Lead regulatory strategy for promotional materials and ensure compliance with FDA communications.
  • Company: Join Artech, the largest women-owned IT staffing company in the U.S., known for its diverse workforce.
  • Benefits: Enjoy a dynamic work environment with opportunities for growth and collaboration across global teams.
  • Why this job: Be part of a fast-growing company that values diversity and offers impactful work in regulatory affairs.
  • Qualifications: 5+ years of experience in regulatory review of promotional materials is essential.
  • Other info: Confidentiality assured; we value your privacy in the application process.

The predicted salary is between 43200 - 72000 £ per year.

Artech Information Systems is the #1 Largest Women-Owned IT Staffing Company in the U.S. and an employer of choice for over 7,500 consultants. We recruit world-class talent for IT, engineering, and other professional jobs at 70+ Fortune and Global 500 companies coast-to-coast across the U.S., India, and China. We are one of the fastest-growing companies in the US. At the forefront of the staffing industry, Artech is a minority and women-owned business enterprise (MWBE) committed to maximizing global workforce solutions on behalf of its clients. Artech's deep heritage, proven expertise and insightful market intelligence has secured long-term partnerships with Fortune 500 and government clients seeking world-class professional resources.

US Regulatory Advertising and Promotion (US Reg AD/Promo) is responsible for actively contributing to the implementation of regulatory strategy for promotional messaging. The contractor will serve as the regulatory representative on assigned review teams for promotional and non-promotional materials and contribute, as appropriate, to other assigned projects.

Essential functions:
  • Responsible for accuracy and content of communications with FDA
  • Extensive knowledge of advertising and promotion regulations and ability to interpret regulations to promotional materials and non-promotional materials
  • Ability to influence teams
  • Actively contribute to the development and implementation of regulatory strategy for promotional materials as well as any other assigned projects and programs.
  • Decision maker in review meetings
  • Responsible for coordinating all aspects of regulatory submissions relevant to assigned projects and programs. This includes promotional materials, including pre-use submissions for subpart E & H products.
  • Provide regulatory guidance to cross-functional teams that establish strategy and vision for promotional materials, sales training materials, and other external communications.
  • Work is performed under general direction. Capable of strategic thinking and risk assessment for area of responsibility. Demonstrate good communication skills (oral/written/listening).

Qualifications: Requires a minimum of 5+ yrs of direct regulatory promotional and non-promotional material review experience.

All your information will be kept confidential according to EEO guidelines.

Senior Manager for Regulatory Affairs employer: Artech Information System LLC

Artech Information Systems stands out as an exceptional employer, offering a dynamic work culture that champions diversity and inclusion, particularly through its status as the largest women-owned IT staffing company in the U.S. Employees benefit from extensive growth opportunities within a fast-paced environment, collaborating with top-tier clients while contributing to meaningful projects in regulatory affairs. With a commitment to professional development and a supportive team atmosphere, Artech is dedicated to empowering its workforce to achieve their career aspirations.
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Contact Detail:

Artech Information System LLC Recruiting Team

StudySmarter Expert Advice 🤫

We think this is how you could land Senior Manager for Regulatory Affairs

✨Tip Number 1

Familiarise yourself with the latest FDA regulations and guidelines related to advertising and promotion. This knowledge will not only help you in interviews but also demonstrate your commitment to staying updated in the field.

✨Tip Number 2

Network with professionals in regulatory affairs, especially those who have experience in promotional materials. Engaging with industry experts can provide insights and potentially lead to referrals for the position.

✨Tip Number 3

Prepare to discuss specific examples of how you've influenced teams or contributed to regulatory strategies in your previous roles. Highlighting your decision-making skills will be crucial during the interview process.

✨Tip Number 4

Research Artech Information Systems and their clients to understand their values and mission. Tailoring your conversation to align with their goals can set you apart as a candidate who truly fits their culture.

We think you need these skills to ace Senior Manager for Regulatory Affairs

Regulatory Knowledge
Advertising and Promotion Regulations
Strategic Thinking
Risk Assessment
Cross-Functional Collaboration
Decision-Making Skills
Communication Skills (Oral/Written/Listening)
Project Management
Attention to Detail
Influencing Skills
Analytical Skills
Experience with FDA Communications
Ability to Interpret Regulations
Team Leadership

Some tips for your application 🫡

Understand the Role: Before applying, make sure you fully understand the responsibilities and qualifications required for the Senior Manager for Regulatory Affairs position. Tailor your application to highlight your relevant experience in regulatory strategy and promotional material review.

Craft a Strong CV: Your CV should clearly outline your 5+ years of experience in regulatory affairs, particularly in advertising and promotion. Use specific examples to demonstrate your ability to influence teams and contribute to regulatory strategy.

Write a Compelling Cover Letter: In your cover letter, express your passion for regulatory affairs and how your background aligns with Artech's mission. Highlight your strategic thinking and risk assessment skills, as well as your ability to communicate effectively with cross-functional teams.

Proofread Your Application: Before submitting, carefully proofread your CV and cover letter for any errors or inconsistencies. A polished application reflects your attention to detail, which is crucial in regulatory affairs.

How to prepare for a job interview at Artech Information System LLC

✨Know Your Regulations

Make sure you have a solid understanding of advertising and promotion regulations. Be prepared to discuss how you've interpreted these regulations in your previous roles, as this will demonstrate your expertise and ability to contribute to the regulatory strategy.

✨Showcase Your Influence

During the interview, highlight instances where you've successfully influenced teams or decisions. This role requires collaboration with cross-functional teams, so sharing specific examples will show that you can effectively guide others in regulatory matters.

✨Prepare for Scenario Questions

Expect scenario-based questions that assess your decision-making skills in review meetings. Think about past experiences where you had to make tough calls regarding promotional materials and be ready to explain your thought process.

✨Communicate Clearly

Since good communication skills are essential for this role, practice articulating your thoughts clearly and concisely. Whether it's discussing your experience or answering questions, clear communication will help you stand out as a candidate.

Senior Manager for Regulatory Affairs
Artech Information System LLC
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