- Representing Global CMC Regulatory, on Regulatory Networks and Matrix Teams, providing and overseeing strategic direction and guidance to other functional areas on both global project and key strategic business initiatives.
- Creation, maintenance and continuous improvement of CMC Regulatory processes, policies, and systems, including the design and implementation of any new standards or procedures.
- Delivering CMC regulatory strategy to support major inspections or quality incidents, taking an active role in any business-critical activities as required.
- Understanding, interpreting, and advising on regulations, guidelines, procedures, policies, and strategies relating to development, registration, and manufacturing of products, aiming to expedite submission and approval of CMC applications.
- Ensuring appropriate strategies for CMC aspects of product release and stability are in place to ensure continuity of supply.
- Directing project activities and strategies for multiple projects, including communication of risk mitigation strategies to senior management.
- Leading, influencing, and motivating staff within and across departments, essentially leading the company position on internal/external CMC Regulatory.
- Direction and communication of complex regulatory issues at senior levels, including internally and with external agencies and third parties.
- Bachelor's degree in Chemistry, Pharmacy or related scientific area of concentration.
- Drug Development, manufacturing, and supply processes background.
- Complex worldwide CMC regulatory requirements experience, including negotiating with regulatory agencies.
- Leading a regulatory CMC team, including training and development.
- Masters or PhD in life sciences or related scientific discipline
- Awareness and continued pursuit of knowledge regarding global regulatory affairs trends and policies
- A CMC Regulatory expert in a specific subject area
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Director, Regulatory Affairs CMC Small Molecule, Mature Products - Durham, United States - GlaxoSmithKline
Description
Site Name: USA - North Carolina - Research Triangle Park, Bangalore, India - Maharashtra - Mumbai, Poznan Grunwaldzka, UK - London - BrentfordPosted Date: Apr
Are you interested in a highly visible, global role that allows you to lead a team of regulatory experts while being part of the CMC regulatory leadership team to contribute to the advancement of a robust and innovative product pipeline? If so, this role is an exciting move to explore.
GSK has a large, well established and largely in-commercial-supply portfolio in our mature, small molecule products. From a global regulatory perspective, this is a critical position to support this business area in the maintenance of compliant licenses globally, including our internal and external network, which enable continuity of supply. To do so, you will lead a team of managers and product owners, supporting them in the maintenance of license registration, empowering partnerships with manufacturing sites, local and regional regulatory partners, Quality and other stakeholders throughout the business. Together, you will support assessment of risks and issues, providing solutions which enable reliable production and registration of our products.
This is an extremely varied and fast paced area of the business, offering the successful candidate a true breadth of experiences. The position requires technical knowledge, but also significant interpersonal and communication ability. You will need to be flexible, resilient, and adaptable as a result, but success will lead to a high amount of visibility and the chance to build positive relationships throughout the GSK network. Additionally, we need someone who can operate with significant independence and autonomy in this role, meaning you will have the chance to drive improvements and results to best meet the needs of the company. You will fit into a cohesive team of fellow directors, all with a shared focus on capability. It is a high priority to upskill our talent, aid the development of others and then ensure their knowledge and capability is most efficiently deployed.
Key Responsibilities include, but are not limited to:
Why You?
Basic Qualifications:
Minimum requirements for success in the role:
Preferred Qualifications:
#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.
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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. 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.
