Group Manager Regulatory Affairs
Group Manager Regulatory Affairs
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Salary Not Disclosed
1 Vacancy
Job Description
Are you ready to make a significant impact in the pharmaceutical industry Do you have a passion for leadership and building strong teams Join us at GSK as a Group Manager Regulatory Affairs where youll play a crucial role in shaping the future of our products and people. In this dynamic position youll oversee the development of regulatory strategies that drive faster submission approval times secure competitive labelling resolve productrelated challenges and ensure a seamless ongoing supply for products within your specialized Therapy Area.
Youll be at the forefront of building strong collaborative relationships with both internal and external stakeholders earning their trust while helping GSK meet its business goals. Your expertise will directly contribute to the success of our products people and the wellbeing of patients around the globe.
If youre passionate about regulatory affairs building capabilities in others and want to be part of a team thats shaping the future of healthcare this is your chance to make a real difference. Ready to take the next step in your career Apply now and help us deliver innovative solutions that improve patients lives!
Key Accountabilities/Responsibilities:
Oversees the development of regulatory strategies to improve GSK submission approval times achieve competitive labelling resolve product related issues and/or ensure continued supply for products within the Therapy Area or projects within specialization area.
Provides strategic oversight to ensure that clinical trial plans optimize commercial needs and regulatory approval.
Builds relationships and trust with a wide range of internal and external stakeholders to support the needs of the business.
Contributes to the development and implementation of strategic plans.
Provides coaching direction and oversight to Therapy Area and/or CMC staff to ensure adequate capabilities to deliver objectives as well as maintain wellmotivated engaged and resilient team.
Supports the development of staff and builds a talent pipeline.
Manages project prioritization and resource allocation for Therapy Area and/or CMC functions.
Leads change and delivers results in the most effective way possible.
Develops strategies to maximize and drive efficiencies and increase compliance in regulatory processes.
Ensures optimal use of global regulatory support functions.
Ensures compliance with applicable Health Canada industry & GSK codes and guidelines in alignment with business needs.
Qualifications Required:
. in life science or relevant scientific field (e.g. pharmacology toxicology chemistry)
Extensive experience in Regulatory Affairs
Excellent applied scientific knowledge & skills
Must possess a sound understanding of the Canadian Food & Drug Regulations relevant guidelines and policies
Working knowledge of global regulatory agencies and their practices
Must possess a thorough understanding of the drug development and commercialization process
Highly innovative creative problem solver and decision maker who can apply continuous improvement techniques to gain efficiencies in submission preparation and product approval process
Strong ability to apply and leverage scientific knowledge for commercial value. Must work as a strategic partner with crossfunctional teams.
Strong business and financial acumen. Strong strategic thinking skills at the therapeutic level
Demonstrated business planning ability
Active owner and leader of change
Strong leadership team building and people management skills and experience. Demonstrated record in achieving results through others building teams and developing the overall capability of a unit
Excellent communication influencing and relationship management skills
Sound negotiation skills
Ability to engage constructively with others and demonstrate a positive mindset. Willingness to welcome open discussions by inviting and encouraging diverse ideas styles and perspectives
Must act with integrity and demonstrate a strong and effective risk management perspective
Strong commitment to quality mindset
Proactive and seeks to constantly learn and develop to ensure that skills meet changing business needs
Preferred Qualifications:
Experience in Respiratory and/or HIV Therapy Areas
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 its 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.
GSK is an equal opportunity employer committed to diversity and welcome applications from all qualified individuals to apply to our career opportunities. GSK is committed to accommodating persons with disabilities. If you need accommodation at any stage of the application process or want more information on our accommodation policies please contact us at .Please do not send resumes to this email and instead apply through the online application process of this posting.
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 GSKs 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. GSK shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses/agencies in respect of the vacancies posted on this site.
Required Experience:
Manager
Employment Type
Full-Time
