CMC Regulatory Affairs Manager/Associate Director (Biologics)

Employer
GSK
Location
Waltham, Massachusetts
Salary
Competitive
Closing date
Dec 6, 2022

View more

Sector
Pharmaceutical, Regulatory Affairs
Organization Type
Corporate
Jobseeker Type
Professional
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 and Cell & Gene Therapy products. This role requires you to interact across all the functions of Global Regulatory Affairs 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 can be based at our sites at Ware, Hertfordshire, Waltham Massachusetts, Rockville Maryland or at Upper Providence, Pennsylvania, USA, however this role will interact across our global network.

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 one or multiple projects/teams 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 through to marketing applications and post approval 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 submission, review and approval of global CMC applications.
  • You will work in cross-functional matrix project teams, which include colleagues from regulatory, biopharmaceutical development 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:

In this role you will require a bachelor's degree (or equivalent) within a relevant subject such as pharmacy, biotechnology, chemistry or a related scientific discipline.

You will also possess:
  • Minimum of one year experience in Chemistry, Manufacturing and Controls (CMC) regulatory affairs or biopharmaceutical development experience gained with direct involvement in regulatory submission preparation across all stages of development, through to early commercial life cycle submissions.
  • One or more years' experience working with worldwide CMC regulatory requirements and successful track record of delivering dossiers that comply with these, particularly for new medicines in development.
  • One or more years' experience related to the development and implementation of regulatory strategies and evaluate the potential impact of them on overall project/product strategy.


Preferred Qualifications:

If you have the following characteristics, it would be a plus:
  • Strong verbal and written communication skills with good attention to detail.
  • Excellent team working abilities and effective influencing skills.
  • Ability to find innovative solutions to complex problems and involvement in continuous improvement initiatives.
  • Good time management skills with the ability to effectively plan, priorities and co-ordinate multiple tasks and adjust to changing priorities to deliver results to tight deadlines.
  • 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.
  • The ability to successfully influence and negotiate issues at a senior level within your organization and with regulatory agencies in a variety of settings.


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.

#LI-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 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.

If you require an accommodation or other assistance to apply for a job at GSK, please contact the GSK Service Centre at 1-877-694-7547 (US Toll Free) or +1 801 567 5155 (outside US).

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.

At GSK, the health and safety of our employees are of paramount importance. As a science-led healthcare company on a mission to get ahead of disease together, we believe that supporting vaccination against COVID-19 is the single best thing we can do in the US to ensure the health and safety of our employees, complementary workers, workplaces, customers, consumers, communities, and the patients we serve.

GSK has made the decision to require all US employees to be fully vaccinated against COVID-19, where allowed by state or local law and where vaccine supply is readily available. The only exceptions to this requirement are employees who are approved for an accommodation for religious, medical or disability-related reasons.

Important notice to Employment businesses/ Agencies

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.

Please note that if you are a US Licensed Healthcare Professional or Healthcare Professional as defined by the laws of the state issuing your license, GSK may be required to capture and report expenses GSK incurs, on your behalf, in the event you are afforded an interview for employment. This capture of applicable transfers of value is necessary to ensure GSK's compliance to all federal and state US Transparency requirements. For more information, please visit GSK's Transparency Reporting For the Record site.

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