City : 2323 duParc Technologique Blvd

Category : Other

Industry : Healthcare

Employer : GSK

As a Senior Manager CMC Vx Development Projects you will direct the CMC regulatory activities of multiple projects.

This role will provide YOU the opportunity to lead key activities to progress YOUR career.  These responsibilities include some of the following:

• Drive the CMC strategy, coordinates the timely preparation and authors, as needed, technical (CMC) regulatory documents to support development and registration of new vaccines or lifecycle activities and maintenance of registered vaccines, in accordance with the applicable regulatory & scientific standards, taking into account the evolving regulatory requirements. 
• Provide regulatory advice and guidance to the Technical Development Team and/or Technical Life-Cycle Team (TLCT), Implementation Committee, Specification Review Committee, Technical Review Board, CMC Expert Panel, and provides regulatory support to their partners in R&D, Quality Control, Manufacturing, QA and Supply.  Ensures adequate interaction and partnership with the Global Regulatory Lead’s team in order to define proper regulatory CMC filing strategy. 
• Lead CMC Regulatory discussions during interactions with Worldwide regulatory authorities.  
• Ensure, in a continuous improvement mindset, regulatory compliance is maintained and shares best-practices and learnings within the CMC Regulatory teams and other impacted functions.  
• Engage and leads CMC Subject Matter Expert activities, both internally (for increased compliance, harmonisation and efficiency) and externally  (external advocacy and shaping the regulatory environment). He/She, in a continuous improvement mindset, will ensure regulatory compliance is maintained and share best-practices and learnings within the CMC Regulatory teams. 
• Mentor or trains staff. May have direct line or lead management responsibility.
• May participate in corporate evaluation and provide CMC regulatory support/advice to in-licensing and divestment projects.
• Deliver CMC regulatory strategy to support major inspections (eg PAI's) or quality incidents (PIRCs).

Why you?

Basic Qualifications:

We are looking for professionals with these required skills to achieve our goals:

• Master’s degree or above in Chemistry, pharmacy, biological or closely related science advanced degree.

  Regulatory Affairs Certification (e.g. RAPS).
• Detailed knowledge of drug development and manufacturing and supply processes and may have a specialized area of expertise.
• Detailed working knowledge of complex worldwide CMC regulatory requirements and demonstrated ability to influence the global internal/external regulatory environment. 
• Proven project management and multi-tasking skills.
• High ability to manage and direct multiple projects/teams
• Track record of effective influencing and negotiating with regulatory agencies, industry bodies, and personnel in a variety of settings
• Demonstrated ability to handle complex global CMC issues through continuous change and improvement.

Preferred Qualifications:

If you have the following characteristics, it would be a plus:

• Significant experience in Pharmaceutical industry or Research organizations, established in Regulatory Affairs and with demonstrated experience of team leadership
• Continued professional growth in global regulatory affairs including communication of evolving/emerging trends and policies.  Has identified opportunities to further educate colleagues and formulate approaches to most effectively meet new requirements.
• Identified as CMC Regulatory expert in a specific subject area.
• Highly developed interpersonal, presentation and communication skills.
• Proven experience in supervising and training staff within an organisation.

Why GSK?

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. Getting ahead means preventing disease as well as treating it, and we aim to impact the health of 2.5 billion people around the world in the next 10 years.

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.

*Li-GSK

If you have a disability and require assistance during the course of the selection process, you will have the opportunity to let us know what specific assistance you require in order to make suitable arrangements.

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. Getting ahead means preventing disease as well as treating it, and we aim to positively impact the health of 2.5 billion people by the end of 2030.

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 workplace where everyone can feel a sense of belonging and thrive as set out in our Equal and Inclusive Treatment of Employees policy. We’re committed to being more proactive at all levels so that our workforce reflects the communities we work and hire in, and our GSK leadership reflects our GSK workforce.

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