Associate Director/Manager, CMC Regulatory Affairs

Company: GlaxoSmithKline
Location: Waltham
Posted on: September 12, 2020

Job Description:

Associate Director/Manager, CMC Regulatory Affairs Waltham, Massachusetts

Regulatory

255681

Job description Site Name: USA - Massachusetts - Waltham

Posted Date: Jun 23 2020

We’re seeking a highly motivated, self-driven and enthusiastic Regulatory Affairs professional to join our CMC Regulatory Affairs Group supporting the GSK Strategic External Development (SED) organization. At GSK, our CMC regulatory affairs group is responsible for a portfolio of biopharmaceutical products as well as small molecule products. This role requires you to interact across all the functions to ensure global approaches and strong connectivity. You will play a key part in GSK’s commitment to making a difference to patients’ lives enabling them to Do More, Feel Better and Live Longer.

This role will be based at our Waltham, MA site, however this role will interact across our global network. Reporting to the Director of CMC Regulatory Affairs, this position will plan and coordinate regulatory strategies necessary to support clinical development submissions, new registrations, and post approval submissions that meet global regulatory requirements and company business goals.

This role will provide YOU the opportunity to lead key activities to progress YOUR career, these responsibilities include some of the following…

You will manage, or be responsible for, the global CMC regulatory activities for assigned projects and respond readily to changing events and priorities.

You will be responsible for the strategy development and creation of CMC submission documents from early phase clinical submissions (IND/IMPD) through to marketing applications (BLA/MAA) and lifecycle management activities.

You will need to understand, interpret and advise teams on regulations, guidelines, procedures and policies relating to development, registration and manufacture of new biopharmaceutical products, to expedite the submission, review and approval of global CMC applications.

You will work in cross-functional matrix project teams, which include colleagues from regulatory, biopharmaceutical development, quality and manufacturing.

You will maintain high quality standards and seek to raise levels of performance through continuous improvement and an innovative approach in responding to the evolving regulatory environment.

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

Bachelor degree (or equivalent) within a relevant subject such as biology, pharmacy, chemistry or a related scientific discipline

At least 7 years of pharmaceutical company experience.

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

You will manage, or be responsible for, the global CMC regulatory activities for assigned projects and respond readily to changing events and priorities.

You will be responsible for the strategy development and creation of CMC submission documents from early phase clinical submissions (IND/IMPD) through to marketing applications (BLA/MAA) and lifecycle management activities.

You will need to understand, interpret and advise teams on regulations, guidelines, procedures and policies relating to development, registration and manufacture of new biopharmaceutical products, to expedite the submission, review and approval of global CMC applications.

You will work in cross-functional matrix project teams, which include colleagues from regulatory, biopharmaceutical development, quality and manufacturing.

You will maintain high quality standards and seek to raise levels of performance through continuous improvement and an innovative approach in responding to the evolving regulatory environment.

Why GSK?

Our values and expectations are at the heart of everything we do and form an important part of our culture.

These include Patient focus, Transparency, Respect, Integrity along with Courage, Accountability, Development, and Teamwork. As GSK focuses on our values and expectations and a culture of innovation, performance, and trust, the successful candidate will demonstrate the following capabilities:

Agile and distributed decision-making – using evidence and applying judgement to balance pace, rigour and risk

Managing individual and team performance.

Committed to delivering high quality results, overcoming challenges, focusing on what matters, execution.

Implementing change initiatives and leading change.

Sustaining energy and well-being, building resilience in teams.

Continuously looking for opportunities to learn, build skills and share learning both internally and externally.

Developing people and building a talent pipeline.

Translating strategy into action - a compelling narrative, motivating others, setting objectives and delegation.

Building strong relationships and collaboration, managing trusted stakeholder relationships internally and externally.

Budgeting and forecasting, commercial and financial acumen.

Excellent verbal and written communication skills.

Ability to work independently with minimal supervision as well as in a team environment

The ability to successfully influence and negotiate issues at the appropriate level within your organisation and/or with regulatory agencies in a variety of settings.

Strong problem-solving skills to evaluate technical information and identify appropriate regulatory strategies and actions.

Proven ability to develop and implement regulatory strategies and evaluate the potential impact of them on overall project/product strategy.

Ability to find innovative solutions to complex problems and involvement in continuous improvement initiatives.

Experience of Agency interactions and/or submissions in US, EU, Japan and China.

Resourceful, creative, enthusiastic, and results-oriented

Self-motivated, assertive, self-confident and acts with a sense of urgency and passion

Proven ability to work with a high level of integrity, accuracy, and attention to detail

Why GSK? Our values and expectations are at the heart of everything we do and form an important part of our culture. These include Patient focus, Transparency, Respect, Integrity along with Courage, Accountability, Development, and Teamwork. As GSK focuses on our values and expectations and a culture of innovation, performance, and trust, the successful candidate will demonstrate the following capabilities:

Operating at pace and agile decision-making – using evidence and applying judgement to balance pace, rigour and risk.

Committed to delivering high quality results, overcoming challenges, focusing on what matters, execution.

Continuously looking for opportunities to learn, build skills and share learning.

Sustaining energy and well-being.

Building strong relationships and collaboration, honest and open conversations.

Budgeting and cost-consciousness.

*LI-GSK

*This is a job description to aide in the job posting, but does not include all job evaluation details.

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Associate Director/Manager, CMC Regulatory Affairs Full-Time, Waltham, Massachusetts, United States Associate Director/Manager, CMC Regulatory Affairs Full-Time, Waltham, Massachusetts, United States Start a career with purpose GSK is a place where outstanding people do amazing things. As a science-led global healthcare company, we exist to help people do more, feel better, live longer.

Annual bonus based on company performance

Long term incentives and pension plan

Learning and career development

Access to healthcare & wellbeing programmes

Keywords: GlaxoSmithKline, Waltham , Associate Director/Manager, CMC Regulatory Affairs, Other , Waltham, Massachusetts