Associate Regulatory Affairs Scientist Intern | Job in Herefordshire

In this role as an Associate Regulatory Affairs Scientist Intern, you will play a crucial part in ensuring compliance with regulations and standards within the pharmaceutical industry in the West Midlands region. Your primary duties will encompass supporting regulatory submissions, maintaining up-to-date knowledge of relevant guidelines, and collaborating with cross-functional teams to ensure product compliance throughout its lifecycle.

Key Responsibilities:

• Assist in preparing and submitting regulatory documentation, including applications for market authorization and post-market changes.
• Collaborate with various departments such as Quality Assurance, Research & Development, and Manufacturing to gather necessary information and ensure compliance with applicable regulations.
• Keep abreast of current and emerging global and local regulatory requirements relevant to the pharmaceutical industry and apply this knowledge to ongoing projects.
• Provide technical and regulatory support for product life cycle management and product transfers.
• Contribute to the development and implementation of strategies for regulatory compliance and continuous improvement in Regulatory Affairs.
• Participate in internal and external meetings with regulatory authorities, as required.
• Draft and review various regulatory documents, such as regulatory correspondence, responses to inspection findings, and other regulatory communications.
• Assist in the preparation of regulatory reports and submissions for product approvals, renewals, and variations.
• Collaborate with other departments, including Legal, Quality Assurance, and Risk Management, to ensure compliance with regulations and best practices.
• Support the training and development of junior team members within the Regulatory Affairs department.

By joining our team as an Associate Regulatory Affairs Scientist Intern, you will have the opportunity to work in a dynamic and innovative environment, gain valuable experience in the pharmaceutical industry, and contribute to the development and approval of products that make a positive impact on patients' lives.

Overview

Welcome to an exciting opportunity as an Associate Regulatory Affairs Scientist Intern with our company in the heart of the West Midlands! This internship is a fantastic stepping stone for those who are passionate about regulatory affairs within the scientific industry and seeking to further their career.

Our organisation prides itself on being at the forefront of innovation, consistently pushing boundaries and challenging convention within the field. We believe that our internship program is a key component in nurturing the scientists of tomorrow, providing them with the skills, knowledge, and experience required to make a real impact in this dynamic industry.

As an Associate Regulatory Affairs Scientist Intern, you will be working alongside our dedicated regulatory affairs team, learning the intricacies of the regulatory landscape and gaining hands-on experience in ensuring compliance across our product portfolio. You'll have the opportunity to:

• Assist in preparing and submitting regulatory applications for new products or updates to existing ones.
• Collaborate with cross-functional teams to ensure compliance with regional and international regulations.
• Participate in the development of regulatory strategies for new projects.
• Stay up-to-date with changes in regulatory requirements and industry trends.
• Support in managing the regulatory aspects of product lifecycle, from pre-clinical through to post-market.

Ideal candidates will have a strong academic background in a relevant scientific discipline (e.g., Life Sciences, Chemistry, or related fields) and a keen interest in regulatory affairs. Excellent communication skills, both written and verbal, are essential as you'll be expected to collaborate with various teams and external stakeholders effectively.

Our internship offers a unique chance to work on cutting-edge projects while gaining valuable insights into the world of regulatory affairs. Don't miss this opportunity to kickstart your career in science and join us at our West Midlands location today! Apply now, and let's create a future together.

Position Details

We are currently seeking an enthusiastic and dedicated individual to join our team as an Associate Regulatory Affairs Scientist Intern based in the West Midlands. This internship offers a unique opportunity to work with a dynamic and innovative company, providing valuable experience in the field of Regulatory Affairs within the scientific industry.

• Assist in the preparation and submission of regulatory documents to relevant authorities.

• Conduct research and analysis to ensure compliance with regulatory requirements.

• Collaborate with cross-functional teams to support product development and launches, ensuring compliance throughout the process.

• Participate in the maintenance and updates of regulatory databases and documentation systems.

• Support the team in the preparation for audits and inspections by regulatory authorities.

• Keep abreast of changes in regulatory requirements and industry trends, and share insights with the team.

• Provide technical support to the Regulatory Affairs team as required.

• Degree in a relevant scientific discipline (e.g., Biology, Chemistry, Pharmacy, etc.) from a recognized institution.

• Strong understanding of regulatory affairs within the scientific industry.

• Excellent written and verbal communication skills.

• Ability to work effectively both independently and as part of a team.

• Strong organizational skills with the ability to manage multiple tasks simultaneously.

• Flexibility to adapt to changing priorities and work in a fast-paced environment.

• Strong analytical and problem-solving skills.

• Proficiency in using Microsoft Office Suite and regulatory databases is desirable.

• A unique opportunity to gain practical experience in Regulatory Affairs within the scientific industry.

• Collaborative and supportive work environment.

• Competitive internship remuneration.

• Opportunities for professional development and career advancement.

• Central location in the West Midlands with easy access to public transportation.

Interested candidates should submit their CV, cover letter, and academic transcripts to our HR department via email or through our online application portal. Only shortlisted candidates will be contacted for an interview.

is an equal opportunity employer and welcomes applications from all qualified individuals regardless of race, gender, age, religion, sexual orientation, or national origin. We are committed to creating a diverse and inclusive workforce.

We look forward to receiving your application!

Professional Skills

The following professional skills are essential for the role of Associate Regulatory Affairs Scientist Intern:

• Regulatory Knowledge: Thorough understanding of local and international regulations governing pharmaceutical and biotechnology products, including ICH, GMP, GLP, and GCP guidelines.

• Scientific Research and Writing: Ability to conduct comprehensive scientific research, analyze data, and write clear, concise, and accurate reports. Proficiency in using scientific databases and literature search tools is required.

• Project Management: Excellent organizational skills to manage multiple projects simultaneously, prioritize tasks effectively, and meet project deadlines.

• Communication Skills: Strong verbal and written communication skills to liaise with internal teams, regulatory authorities, and external partners. Ability to present complex scientific information in a clear and understandable manner is crucial.

• Problem-Solving Skills: Capability to analyze problems, develop effective solutions, and implement them in a timely manner.

• Attention to Detail: High level of accuracy and attention to detail in all tasks, particularly when dealing with regulatory submissions and technical reports.

• Adaptability: Ability to adapt to changing situations and priorities, and to learn new technologies and systems quickly.

• Teamwork: Strong team player who can collaborate effectively with colleagues from various departments. Willingness to provide and receive feedback is essential.

• Integrity: Commitment to maintaining the highest ethical standards in all professional interactions, particularly regarding confidential information.

• IT Proficiency: Familiarity with Microsoft Office Suite (Word, Excel, PowerPoint) and other relevant software for regulatory affairs work, such as electronic submission systems like eCTD. Familiarity with databases such as Regulatory DataBase (RDB), S-files, or similar would be an advantage.

Organization Info

*Company Overview *

We are a dynamic and innovative life sciences organization based in the heart of the West Midlands. Our mission is to contribute to human health and well-being by advancing science, improving technology, and providing high-quality products and services that make a real difference in people's lives. We are committed to fostering a culture of integrity, collaboration, and continuous learning.

*Department Overview *

The Regulatory Affairs department plays a pivotal role in ensuring our products meet the necessary regulatory standards while maintaining our commitment to quality and patient safety. The department is responsible for managing the regulatory compliance process across all stages of product development and throughout the entire product lifecycle.

*Role Description: Associate Regulatory Affairs Scientist Intern *

The Associate Regulatory Affairs Scientist Intern will be an integral part of our Regulatory Affairs team, providing support in various aspects of regulatory compliance and documentation management. This is a fantastic opportunity for a science graduate with an interest in regulatory affairs to gain hands-on experience in the field.

*Key Responsibilities: *

• Assist in the preparation and submission of regulatory documents to relevant authorities.
• Support the team in maintaining and updating regulatory databases and documentation systems.
• Collaborate with cross-functional teams to ensure compliance with global regulations throughout product development.
• Participate in regulatory meetings, provide updates on regulatory issues, and support decision-making processes.
• Contribute to the creation of Standard Operating Procedures (SOPs) and other regulatory guidance documents.
• Stay updated on industry trends, new regulations, and guidance documents.
• Assist in the preparation for and participation in inspections and audits by regulatory authorities.

*Qualifications: *

• Bachelor's degree in a relevant scientific discipline (e.g., Biology, Chemistry, or related field).
• Strong analytical skills with attention to detail.
• Excellent communication skills, both written and verbal.
• Ability to work effectively in a team environment.
• Proactive and self-motivated individual with a strong desire to learn and grow professionally.
• Familiarity with regulatory affairs and quality systems is advantageous but not required.

*Additional Information: *

• This is an internship position, lasting for 12 months.
• The successful candidate must be eligible to work in the United Kingdom.
• We offer a competitive salary and benefits package, as well as opportunities for professional development and career growth.