GSK

Associate Director/Manager, CMC Regulatory Affairs

Employer
GSK
Location
Waltham, Massachusetts; Collegeville, Pennsylvania
Salary
Competitive
Posted
October 01 2020
Ref
266033
Organization Type
Pharma
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 expectationsare 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

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GSK is an Equal Opportunity Employer and, in the US, we adhere to Affirmative Action principles. This ensures that all qualified applicants will receive equal consideration for employment without regard to race, color, national origin, religion, sex, pregnancy, marital status, sexual orientation, gender identity/expression, age, disability, genetic information, military service, covered/protected veteran status or any other federal, state or local protected class.

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