Regulatory Affairs Manager, Oncology - Mississauga, Canada - 837 GlaxoSmithKline Inc.

837 GlaxoSmithKline Inc. Mississauga, Canada

2 weeks ago

Full time

Description

Key Accountabilities/Responsibilities:

Develops regulatory strategies for rapid approvals with optimal labelling for products within therapy or for submissions within specialization area

Accountable for a portfolio of products, specific in the Oncology therapy area, including the preparation, filing and approval of regulatory submissions (NDSs, SNDSs, CTAs, NCs, etc) to aggressive targets

Ensures compliance with applicable Health Canada, industry, and GSK codes and guidelines in alignment with business needs

Builds trust with Health Canada contacts to improve GSK submission approval times, achieve competitive labelling and resolve product related issues impacting submissions, or compliance activities

Communicates with and influences multiple local and global functions, to achieve regulatory objectives

Identifies and responds to issues related to assigned projects and/or products

Interprets Canadian regulations, guidelines and policies as they apply to GSK regulatory activities

Mentors and trains junior staff

Qualifications Required:

B.Sc. in life science or relevant scientific field (e.g. pharmacology, toxicology, chemistry)

Extensive Canadian regulatory affairs experience leading multiple submissions at all stages of the product lifecycle

Must possess a thorough understanding of the Canadian Food & Drug Regulations, relevant guidelines and policies

Must possess a thorough understanding of drug development and commercialization process

Highly innovative (strategic and functional) and creative problem solver and decision maker who can apply continuous improvement techniques to gain efficiencies in submission preparation, product approval process, and resolving issues

Agile and able to effectively navigate change

Demonstrated ability to develop effective regulatory strategies aligned with commercial objectives

Working knowledge of global regulatory agencies and their practices

Excellent oral and written communication skills including the ability to present information and contribute ideas in small and large groups

Good influencing and relationship management skills

Excellent negotiation skills

Fully developed project management skills

Must act with integrity and demonstrate a strong and effective risk management perspective

Ability to provide and receive feedback, raise issues, share experiences and lessons learned.

Proactive and seeks to constantly learn and develop, ensures that skills meet changing business needs

Fosters strong team collaboration, with the ability to engage constructively with others and demonstrate a positive mindset. Open to diverse ideas, styles and perspectives.

Strong commitment to quality mindset

Strong computer literacy and computer skills including Word, Excel, PowerPoint, Outlook

Preferred Qualifications

Graduate degree and/or Post-Graduate Certificate in Regulatory Affairs.

#LI-GSK

Why GSK?

Uniting science, technology and talent to get ahead of disease together.

GSK is a global biopharma company with a special purpose – to unite science, technology and talent to get ahead of disease together – so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns – as an organisation where people can thrive. We prevent and treat disease with vaccines, specialty and general medicines. We focus on the science of the immune system and the use of new platform and data technologies, investing in four core therapeutic areas (infectious diseases, HIV, respiratory/ immunology and oncology).

Our success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders, it's also about making GSK a place where people can thrive. We want GSK to be a place where people feel inspired, encouraged and challenged to be the best they can be. A place where they can be themselves – feeling welcome, valued, and included. Where they can keep growing and look after their wellbeing. So, if you share our ambition, join us at this exciting moment in our journey to get Ahead Together.

Important notice to Employment businesses/ Agencies

GSK does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact GSK's commercial and general procurement/human resources department to obtain prior written authorization before referring any candidates to GSK. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and GSK. In the absence of such written authorization being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of GSK.

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Description

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