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Manager, Regulatory Affairs

Employer
Emergent BioSolutions
Location
Gaithersburg, MD
Start date
Sep 24, 2022

View more

Discipline
Regulatory, Regulatory Affairs
Required Education
Bachelors Degree
Position Type
Full time
Hotbed
BioCapital
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Job Details

 

Those who join Emergent BioSolutions feel a sense of ownership about their future. You will excel in an environment characterized by respect, innovation and growth opportunities. Here, you will join passionate professionals who advance their scientific, technical and professional skills to develop products designed-to protect life.

 

MANAGER, REGULATORY AFFAIRS (CANADA)

 

Emergent BioSolutions is currently seeking a Manager, Regulatory Affairs for our Winnipeg office. The select candidate will have a Bachelor’s degree in a life sciences or related discipline, 8+ years of relevant pharmaceutical industry experience with a minimum of 5 years’ experience in Regulatory Affairs.  Must have experience interacting with the FDA, EMA, Health Canada and/or other agencies as required. The ideal candidate will be able to identify priorities and key issues in complex situations, exercise judgement within generally defined regulatory practices and knowledge and the experience of the development of one or more types of Health Authority regulated products. In addition, this individual will possess a strong work ethic and a commitment to excellence and innovation.

 

THE COMPANY

 

Emergent BioSolutions is dedicated to one simple mission—to protect and enhance life.

As a global specialty pharmaceutical company, Emergent offers specialized products to healthcare providers and governments to address medical needs and emerging health threats.

 

We value the diversity that each employee brings, and while we look for people who share our Core Values, we thrive on difference as well. With hundreds of talented employees working around the globe, Emergent is a growing organization with a wide variety of scientific, technical and professional career opportunities worldwide.

 

THE OPPORTUNITY

 

The Manager Regulatory Affairs (RA) will support regulatory activities related to Chemistry Manufacturing and Controls (CMC) with a focus on change controls and post-approval product lifecycle maintenance and report to the Snr. Manager, RA.  The Manager will provide regulatory support and advice to assigned project teams with respect to CMC changes. The Manager will support and advise on the development of a sound regulatory strategy and follow-through to implementation to assigned project teams accordingly.    The Manager will support the Snr. Manager and other RA product leads on regulatory activities related to CMC and/or facility changes and advise on the global RA Change Control and Change Control Assessment process. The Manager will support and work with other RA team members and product leads to ensure best outcomes for CMC changes.  They will educate teams regarding regulatory risks and implications for strategy, product/process development, and/or post approval change activities, and utilize technical knowledge and effectively apply regulations and guidelines to the assigned projects. The manager may be involved with other regulatory activities, including the management of authoring, review, and coordination of submissions, as needed.

 

DUTIES & RESPONSIBILITIES

 

Major Responsibilities and Duties:

    • Support Emergent manufacturing facilities and the associated product portfolio change controls and product lifecycle maintenance as needed.
    • Provide regulatory assessment for deviations, change controls and manage associated regulatory activities to ensure compliance, as required.
    • Own and drive the processing of RA assessments for site change control, including the tracking and logging of changes and utilizing the site electronic data management system (EDMS) and other computer systems used in the change management process
    • Support and advise the global RA team on the global process for product change control process and, as required, global CMC changes.
    • Assess and triage site change controls for the RA Product and/or CMC Facility Leads and advise on RA assessments; ensuring consistency in assessment(s) of changes across the Emergent product portfolio, as needed.
    • Work with RA Product Leads and RA CMC/Facility Leads to ensure regulatory requirements are met to enable CMC initiatives.
    • Support the RA Product Lead in the development of innovative, risk-based, regulatory strategies for significant CMC changes for Emergent products.
    • Represent RA site initiatives for CMC changes as required; provide guidance to project teams with respect to regulatory expectations and data requirements.
    • Monitor industry (e.g. FDA, Health Canada, EMA, WHO and ICH guidance documents) landscape for pertinent and impactful guidance, policies, with focus on regulatory CMC compliance and industry best practices, apply and provide this regulatory intelligence to project teams as applicable.
    • Provide critical review, and feedback of all documentation supporting CMC regulatory documents, including but not limited to, CTD narratives, validation protocols and reports.
    • Plan, coordinate, prepare and lead meetings and teleconferences with regulatory agencies on complex and strategic related CMC projects and/or programs.
    • Build professional relationships, influence and interact with internal (i.e. subject matter experts with Emergent and across Emergent’s manufacturing facilities) and external (e.g. the FDA) customers.
    • Work closely with Regulatory Product Leads, Regulatory CMC/Facility Leads and Regulatory Operations for timely submission of drug master files and establishment licensing documents (electronic and paper submissions) as required.
    • Lead annual report, lot distribution report and/or CMC filings to global regulators for Emergent portfolio of products
    • Provide regulatory review, feedback and /or approval for relevant documents.
    • Interact with company partners, consultants, and health authorities for various regulatory matters as needed.
    • Other duties as assigned.

 

The above statements are intended to describe the general nature of work performed by those in this job.  It is not an exhaustive list of all duties, and other duties may be assigned.

  
EDUCATION, EXPERIENCE & SKILLS: 

    • Bachelor’s degree in a life sciences or related discipline required.
    • Experience in pharmaceutical development with a history in process development/validation is an asset.
    • Approximately 8+ years of relevant pharmaceutical industry experience, with minimum 5 years in Regulatory Affairs.  Less experience acceptable for suitable candidates with relevant industry experience and skill sets.
    • Must have experience interacting with the FDA, EMA, Health Canada and/or other agencies as required
    • Experience with biologics and/or vaccines is preferred.
    • Ability to work on problems of diverse scope.
    • RAC certification would be a plus.
    • Identifies priorities and key issues in complex situations and solves with minimal assistance
    • Exercises judgement within generally defined regulatory practices and policies
    • Experienced in leading cross-functional interactions related to regulatory matters
    • Effective in both written and oral communication
    • Is able to direct work as required and manage complexity
    • Knowledge and experience of the development of one or more types of Health Authority regulated products (drugs, biologics, medical devices, combination products)

 

ADDITIONAL REQUIREMENTS:

    • Citizenship/Permanent Resident or Valid Work Permit.
    • Successful Completion of a Criminal Record Check.

 

Interested? Please visit www.emergentbiosolutions.com under the career section to apply today!

 

 

As part of our team, you'll join talented and inspiring colleagues whose sense of purpose complements your own. We offer highly diverse career opportunities, a supportive culture, competitive salaries, flexible work arrangements and an extensive benefits package. Information submitted will be used by Emergent BioSolutions for activities related to your prospective employment. Emergent BioSolutions respects your privacy and any use of the information submitted will be subject to the terms of our Privacy Policy.

Company

Emergent BioSolutions is a global life sciences company whose mission is to protect and enhance life. Through our specialty products and contract development and manufacturing services, we are dedicated to providing solutions that address public health threats. Through social responsibility, we aim to build healthier and safer communities. We aspire to deliver peace of mind to our patients and customers so they can focus on what’s most important in their lives. In working together, we envision protecting or enhancing 1 billion lives by 2030. For more information visit www.emergentbiosolutions.com. Find us on LinkedIn and follow us on Twitter.

Stock Symbol: EBS

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Find Us
Website
Phone
240-631-3200
Location
400 Professional Drive
Suite 400
Gaithersburg
Maryland
20879
United States
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