International Regulatory Affairs Manager (International Program Regulatory Manager)

International Regulatory Affairs Manager (International Program Regulatory Manager)

Full-Time 60000 - 84000 Β£ / year (est.) Home office (partial)
Dr Jobs

At a Glance

  • Tasks: Drive global regulatory strategies and execute registration plans for international markets.
  • Company: Join Novartis, a leader in healthcare committed to diversity and inclusion.
  • Benefits: Enjoy a hybrid work model with flexible hours and corporate perks.
  • Other info: Work in a collaborative environment focused on innovation and patient care.
  • Why this job: Be part of a dynamic team impacting global health while enhancing your career.
  • Qualifications: Experience in regulatory affairs and project management is essential.

The predicted salary is between 60000 - 84000 Β£ per year.

Job Description Summary#LI-Hybrid (3 days per week on-site)Location: London (The Westworks) United KingdomInternal Job Title: International Program Regulatory Manager (IPRM)Are you passionate about driving global regulatory strategies and ensuring timely execution of registration plans As an IPRM youll collaborate closely with international regulatory teams and global functions to support product registrations across diverse international markets. Youll play a key role in maintaining regulatory intelligence enhancing operational efficiency and contributing to cross-functional initiativesall while working under the guidance of the International Program Regulatory Director.Job DescriptionKey responsibilities:Providing input into registration strategies for INT countries and drives the execution of registration plans as defined in the INT RA subteam and in partnership with the countries regional roles and global line functions as applicable including procurement of ancillary documents for submission dossier contribution to responses to Health Authority (HA) questions follow up on key milestone activities by relevant RA and line function stakeholders.Supporting the IPRD in partnering with DU RA roles to obtain digest and communicate efficiently pipeline information to relevant stakeholders.Ensures updates to registration plans are performed timely and with the necessary quality.Supporting the IPRD in the execution of plans for Emerging Markets Brands for assigned projects.Assisting the IPRD in the execution of registration plans for products that target diseases which are predominantly prevalent in INT countries.Partnering the IPRD in the execution of geographic expansion plans for INT countries.Driving the dissemination of information to and education of global roles on INT country/regional requirements.Advancing the implementation of functional or cross-functional initiatives particularly those with potential impacts on INT RA resources or FTE allocations.Essential Requirements:Experience in Regulatory affairs in a country regional or global regulatory setting.Experience in regulatory license maintenance and new product registrationsAbility to work in cross-functional environment.Experience in project management.Highly committed and team oriented.Ability to recognize potential regulatory issues complex situations sound risk assessment and overcoming hurdles.Strong team player.Commitment to Diversity and Inclusion/EEONovartis is committed to building an outstanding inclusive work environment and diverse teams representative of the patients and communities we serve.Skills DesiredClinical Trials Detail-Oriented Drug Development Lifesciences Negotiation Skills Regulatory ComplianceRequired Experience:Manager Key Skills Proofreading,Adobe Acrobat,FDA Regulations,Manufacturing & Controls,Biotechnology,Clinical Trials,Research & Development,GLP,cGMP,Product Development,Chemistry,Writing Skills Employment Type : Full-Time Experience: years Vacancy: 1

International Regulatory Affairs Manager (International Program Regulatory Manager) employer: Dr Jobs

At Novartis, we pride ourselves on being an exceptional employer, offering a dynamic work culture that fosters collaboration and innovation in the heart of London. As an International Regulatory Affairs Manager, you will benefit from our commitment to employee growth through continuous learning opportunities and a diverse, inclusive environment that values your contributions. With a hybrid working model, you can enjoy the flexibility of working three days on-site while being part of a global team dedicated to making a meaningful impact in healthcare.

Dr Jobs

Contact Details:

Dr Jobs Recruitment Team

StudySmarter Expert Advice🀫

We think this is how you could land International Regulatory Affairs Manager (International Program Regulatory Manager)

✨Tip Number 1

Network with professionals in the regulatory affairs field, especially those who have experience in international markets. Attend industry conferences or webinars to connect with potential colleagues and learn about the latest trends and challenges in regulatory strategies.

✨Tip Number 2

Familiarise yourself with the specific regulatory requirements of the countries you will be working with. Understanding the nuances of different regions can set you apart from other candidates and demonstrate your commitment to the role.

✨Tip Number 3

Showcase your project management skills by discussing relevant experiences where you successfully led cross-functional teams. Highlighting your ability to manage complex projects will resonate well with the hiring team.

✨Tip Number 4

Prepare to discuss how you would handle potential regulatory issues during the interview. Think of examples from your past experience where you identified risks and implemented solutions, as this will demonstrate your problem-solving abilities.

We think you need these skills to ace International Regulatory Affairs Manager (International Program Regulatory Manager)

Regulatory Affairs Expertise
Project Management
Cross-Functional Collaboration
Regulatory Compliance
Risk Assessment
Detail-Oriented
Strong Communication Skills

Some tips for your application 🫑

Tailor Your CV:Make sure your CV highlights relevant experience in regulatory affairs, particularly in international settings. Emphasise your project management skills and any specific achievements related to product registrations.

Craft a Compelling Cover Letter:In your cover letter, express your passion for regulatory affairs and how your background aligns with the role. Mention specific experiences that demonstrate your ability to work in cross-functional teams and manage complex regulatory issues.

Highlight Relevant Skills:Clearly outline your skills that are pertinent to the job description, such as negotiation skills, attention to detail, and knowledge of FDA regulations. Use examples to illustrate how you've applied these skills in previous roles.

Proofread Your Application:Before submitting, thoroughly proofread your application materials. Ensure there are no spelling or grammatical errors, as attention to detail is crucial in regulatory affairs. Consider asking a friend or colleague to review it as well.

How to prepare for a job interview at Dr Jobs

✨Understand Regulatory Frameworks

Familiarise yourself with the regulatory frameworks relevant to the international markets you'll be working in. This knowledge will help you demonstrate your expertise and show that you're prepared to tackle the challenges of the role.

✨Showcase Project Management Skills

Be ready to discuss your experience in project management, especially in a regulatory context. Prepare examples of how you've successfully managed timelines, resources, and cross-functional teams to achieve regulatory goals.

✨Highlight Team Collaboration

Emphasise your ability to work in a team-oriented environment. Share specific instances where you've collaborated with diverse teams to drive regulatory strategies or resolve complex issues, showcasing your commitment to teamwork.

✨Prepare for Scenario-Based Questions

Anticipate scenario-based questions that assess your problem-solving skills in regulatory affairs. Think about potential regulatory hurdles you might face and how you would approach overcoming them, demonstrating your analytical thinking and risk assessment abilities.