Associate Director, Regulatory Affairs Cmc

Site Name: USA - Massachusetts - Waltham, Durham Blackwell Street, GSK House, Mississauga, USA - Pennsylvania - Upper Providence, Ware RD, Zug House
Posted Date: Jul 23 2023
Are you looking to lead CMC regulatory activities for Biopharmaceutical products? As a Regulatory Manager/Associate Director you will lead CMC regulatory activities for investigational/or early commercial GSK biopharmaceutical products.
We’re seeking a highly motivated, self-driven and enthusiastic Regulatory Affairs professional to join our Biopharm CMC Regulatory Affairs Group. At GSK, our Biopharm CMC regulatory affairs group is responsible for a portfolio of biopharmaceuticals products. This role requires you to interact across all the functions of Global Regulatory Affairs to ensure global approaches and strong connectivity.
As a Manager/Associate Director Biopharm CMC Regulatory Affairs you will direct the CMC regulatory activities of multiple projects and dosage forms.
This role will provide you the opportunity to lead key activities to progress your career.
Your responsibilities will include:

• Strategy development and creation of CMC submission documents from early phase clinical submissions through to marketing applications and lifecycle activities.
• Maintaining high quality standards and seek to raise levels of performance through continuous improvement and an innovative approach in responding to the evolving regulatory environment.
• Managing the global CMC regulatory activities for multiple projects/teams simultaneously and respond readily to changing events and priorities.
• Representing Global CMC Regulatory, on Regulatory Networks and Matrix Teams providing strategic direction and guidance to Preclinical Development (PCD), Biopharm, Global Supply Chain (GSC), Clinical Supplies, Commercial, Quality Assurance, 3rd Party Contract Management and Global Regulatory and Quality (GRQ) on both global project and key strategic business initiatives.
• Understanding, interpreting and advising teams on regulations, guidelines, procedures and policies relating to development, registration and manufacture of new pharmaceutical products, to expedite submission, review and approval of global CMC applications.

Why you?
Basic Qualifications & Skills:
We are looking for professionals with these required skills to achieve our goals:

• B.Sc. in Life Sciences or related scientific disciplines.
• Three or more years complex worldwide CMC regulatory strategies/requirements and demonstrated ability to influence the global internal/external regulatory environment. 
• One or more years of experience fulfilling a key role in major filing activities.
• Three years or more years of experience in drug development and manufacturing and supply processes and may have a specialized area of expertise.
• Two or more years of experience managing and directing multiple projects/teams in a high matrix environment.

Preferred Qualifications & Skills:
If you have the following, it would be a plus:

• Successfully influenced and negotiated issues with regulatory agencies/stakeholders in a variety of settings.
• Project management experience with excellent interpersonal, presentation and communication skills.
• Ability to find innovative solutions to complex problems and involvement in continuous improvement initiatives.
• MS/PhD in Life Sciences or related scientific disciplines.
• Continued professional growth in global regulatory affairs including communication of evolving/emerging trends and policies.
• Identified as a regulatory expert in a specific subject area
• Experienced in supervising and training junior staff and the ability to motivate and lead others.
• Demonstrated ability to handle complex global CMC issues through continuous change and improvement.

Why GSK?
At GSK, we have already delivered unprecedented change over the past four years, improving R&D, becoming a leader in Consumer Health, strengthening our leadership, and transforming our commercial execution. Now, we’re making the biggest changes we’ve made to our business in over 20 years. We’re on track to separate and create two new companies in 2022: New GSK with a leading portfolio of vaccines and specialty medicines as well as R&D based on immune system and genetics science; and a new world-leading consumer healthcare company of loved and trusted brands.
With new ambition comes new purpose. For New GSK, this is to unite science, talent and technology to get ahead of disease together – all with the clear ambition of delivering human health impact; stronger and more sustainable shareholder returns; and as a new GSK where outstanding people thrive.
Getting ahead means preventing disease as well as treating it. How we do all this is through our people and our culture. A culture that is ambitious for patients – so we deliver what matters better and faster; accountable for impact – with clear ownership of goals and support to succeed; and where we do the right thing. So, if you’re ready to improve the lives of billions, join us at this exciting moment in our journey. Join our challenge to get Ahead 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. 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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