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Regulatory Affairs Submission Associate

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GSK

3mo ago

  • Internship
    Full-time
    Off-cycle Internship
  • Legal
  • Mississauga

AI generated summary

  • You need a Health Sciences degree, strong computer skills, understanding of Regulatory Affairs, good communication, attention to detail, and adaptability in fast-paced environments. Previous pharma experience is a plus.
  • You will assist in planning and preparing regulatory submissions, support compliance activities, collaborate with various teams, and handle ad hoc departmental requests.

Requirements

  • University Degree Health Sciences e.g., Biology, Chemistry, Pharmacology, Toxicology
  • Strong computer literacy and computer skills including Word, Excel, PowerPoint, Outlook
  • Theoretical understanding of Regulatory Affairs and the Drug Development process is required
  • Results oriented with a proven ability to prioritize work and meet challenging deadlines
  • Well-developed time-management and multi-tasking ability
  • Good communication skills including listening, summarizing, probing, clarifying
  • Adaptive communication style with ability to influence and build relationships with others across Divisions
  • Proven ability to interact effectively with a diverse group of business partners individually and within a team environment
  • Diligent with excellent attention to detail and accuracy of work
  • Acts with integrity and demonstrates a strong quality mindset
  • Takes initiative and follows through
  • Very good thinking, creative problem-solving skills and sound judgment
  • Quick learner with ability to work in a fast paced and changing environment
  • Demonstrated ability to remain calm under pressure
  • Ability to provide and receive feedback, raise issues, share experiences and lessons learned
  • Graduate degree and/or Post-Graduate Certificate in Regulatory Affairs
  • Previous pharmaceutical industry experience

Responsibilities

  • Assist Therapy Area staff in the planning and preparation of regulatory submissions (CTA, NDS, S/NDS, N/C), or assist Compliance staff in the planning and implementation of compliance/policy activities/projects
  • Participate in submission preparation or other teams
  • Assist in the regulatory and corporate compliance activities for GSK products
  • Liaise with diverse local and global groups within Regulatory Affairs, Clinical Development, Medical Information, and Drug Safety & Compliance
  • Participate in ad hoc requests to support departmental activities

FAQs

What is the job title for this position?

The job title is Regulatory Affairs Submission Associate.

Where is the position located?

The position is located at Mississauga Milverton Drive.

What is the duration of the contract for this position?

It is a 12-month contract position.

What are the basic qualifications required for this role?

The basic qualifications include a university degree in Health Sciences (e.g., Biology, Chemistry, Pharmacology, Toxicology), strong computer literacy, a theoretical understanding of Regulatory Affairs, and good communication skills.

Is this position suitable for recent graduates?

Yes, this position is suitable for individuals who have graduated within the last 24 months.

What type of educational background is preferred for this position?

A graduate degree and/or post-graduate certificate in Regulatory Affairs is preferred.

What kind of experience is preferred for candidates applying for this role?

Previous pharmaceutical industry experience is preferred.

What skills are necessary for success in this role?

Key skills include strong time-management, multi-tasking abilities, attention to detail, adaptability, teamwork, and problem-solving skills.

How does GSK approach diversity and inclusion in hiring?

GSK is an equal opportunity employer committed to diversity and inclusion, welcoming applications from all qualified individuals.

Does GSK accommodate individuals with disabilities during the application process?

Yes, GSK is committed to accommodating persons with disabilities and provides support during the application process.

What type of projects will the Regulatory Affairs Submission Associate assist with?

The associate will assist with planning and preparation of regulatory submissions and compliance activities/projects.

Will this position require interaction with other departments?

Yes, the associate will liaise with diverse local and global groups within Regulatory Affairs, Clinical Development, Medical Information, and Drug Safety & Compliance.

How important is attention to detail for this role?

Attention to detail is extremely important, as the role requires accurate preparation and submission of regulatory documents.

Is there potential for learning and career development in this role?

Yes, GSK emphasizes continuous learning and skill-building, providing opportunities for personal and professional development.

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GSK

Science & Healthcare
Industry
10,001+
Employees

Mission & Purpose

GSK, or GlaxoSmithKline, is a company that operates in the pharmaceutical and healthcare industry. They are involved in researching, developing, manufacturing, and selling a wide range of prescription medicines, vaccines, and consumer healthcare products. GSK's ultimate aim is to improve the quality of human life by providing innovative and effective healthcare solutions to people worldwide. Their commitment lies in focusing on scientific excellence, developing cutting-edge medicines and vaccines, and addressing global health challenges to help people live longer, healthier lives.

Benefits

  • A competitive base salary

  • An annual bonus based on company performance

  • Access to healthcare and wellbeing programmes, pension plan membership, savings programmes, time off and childcare support

  • Employee recognition programmes that reward exceptional achievements