Regulatory Affairs Associate

Contenido de trabajo

Position Overview

Job Description

Catalent hires people with a passion to make a difference to the health of millions of people globally. Your expertise, coupled with Catalent’s advanced technologies and collaboration with thousands of innovative pharmaceutical, biotech and healthcare companies, will help bring life-enhancing products to the people you know and love. Your talents, ideas and passion are essential to our mission; to develop, manufacture and supply products that help people live better, healthier lives. Interested in learning more about life at Catalent? Start here

Position Summary

Reporting to the Regulatory Affairs Manager, the Regulatory Affairs Associate will assist in providing regulatory services to management throughout the functional operations of improving entire drug development and commercialization process in areas including document authorship and review, preparation of applications for global submission, authorship and review to deficiency responses, and maintaining current regulatory practices and expectations. In addition, the Regulatory Affairs Associate will assist in preparing for legislative and regulatory group meetings and communications as appropriate.

The Role

• Prepare and/or review submissions to Health Canada, US FDA and EU in eCTD format (NDS, ANDS, NDA, ANDA, EU Procedures)
• Prepare and/or review responses to deficiency letters (NONs, NODs, Clarifaxes, IR, CRL, major and minor Amendments, Variations)
• Review Change Controls and provide input into regulatory filing assessment.
• Prepare and/or review documentation for Post Approval submissions.
• Liaise with regulatory agency to ensure prompt regulatory approvals. Raise visibility of issues impacting the overall regulatory strategy.
• Provide regulatory support to internal/external customers through timely review of regulatory documentation.
• Maintain current awareness of regulatory guidelines (Health Canada, FDA, EU, ICH).
• Work closely with management, customers and strategic partners to ensure the needs of Catalent Ontario Ltd., regulatory bodies and customers are appropriately considered and delivered against
• Effectively communicate on a timely basis with management, Catalent Ontario Ltd. functional areas and customers regarding matters to set specifications, author scientific research reports and their regulatory importance
  

The Candidate

• Masters or Bachelor’s degree in Science or related field
• Postgrad. Regulatory Affairs Certificate (RAC) or RAPS/RAC.
• Preferred 2 years of experience in Regulatory Affairs, plus experience in the pharmaceutical industry
• Experience working in a manufacturing, pharmaceutical and/or GMP facility
• Knowledge of local, federal and global regulations and ordinances
• Direct experience supporting preparation, management and follow-up relating to Health Canada/ HPFBI, Europe/EMA and US/FDA inspections
  

Position Benefits

• Comprehensive BenefitPackage (Health, Dental, Vision, & Life Insurance)
• Group Retirement Savings – Registered Pension Plan (RPP) with employer contributions
• Paid Time Off Programs incl. vacation, banked time & personal time
• Employee Reward & Recognition programs
• Opportunities for professional and personal development & growth incl. tuition reimbursement
  

Catalent offers rewarding opportunities to further your career!Join the global drug development and delivery leader and help us bring over 7,000 life-saving and life-enhancing products to patients around the world. Catalent is an exciting and growing international company where employees work directly with pharma, biopharma and consumer health companies of all sizes to advance new medicines from early development to clinical trials and to the market. Catalent produces more than 70 billion doses per year, and each one will be used by someone who is counting on us. Join us in making a difference.

Catalent is committed to the health and safety of its employees, visitors and the customers and patients we serve. As a result of the global pandemic, we have modified many of our recruitment and on-boarding processes to maintain everyone’s safety. The Human Resources teams will communicate all necessary safety processes and procedures throughout each stage.

personal initiative. dynamic pace. meaningful work.

Visit www.catalent.com/careers to explore career opportunities.

C atalent is an Equal Opportunity / Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, sexual orientation or gender identity. If you require reasonable accommodation for any part of the application or hiring process due to a disability, you may submit your request by sending an email, and confirming your request for an accommodation and include the job number, title and location to DisabilityAccommodations@catalent.com . This option is reserved for individuals who require accommodation due to a disability. Information received will be processed by a U.S. Catalent employee and then routed to a local recruiter who will provide assistance to ensure appropriate consideration in the application or hiring process.

Notice to Agency and Search Firm Representatives: Catalent Pharma Solutions (Catalent) is not accepting unsolicited resumes from agencies and/or search firms for this job posting. Resumes submitted to any Catalent employee by a third party agency and/or search firm without a valid written & signed search agreement, will become the sole property of Catalent. No fee will be paid if a candidate is hired for this position as a result of an unsolicited agency or search firm referral. Thank you.