Manager, Regulatory Affairs
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, CMC
Emergent BioSolutions is currently seeking a Manager, Regular Affairs, CMC for our Regulatory Affairs Department. The successful candidate will have a Bachelor’s degree in a life sciences or related discipline, experience in pharmaceutical development with a history in process development/validation and approximately 8+ years of relevant pharmaceutical industry experience with a minimum of 5 years in Regulatory Affairs. Must have experience interacting with the FDA, EMA, Health Canada and/or other agencies as required. Experience with biologics and/or vaccines is preferred. In addition, this individual will possess a strong work ethic and a commitment to excellence and innovation.
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 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)
- Responsibilities may require a work schedule that may include working outside of regular work hours, in order to meet business demands.
- This position requires travel across Canada in fulfilling business needs (60-70%).
- Frequent public and customer contact requiring appropriate business apparel.
- 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!