- SPECIALIST, REGULATORY AFFAIRS
Emergent BioSolutions is currently seeking a Sr. Manager, GXP Compliance. The successful candidate will have a bachelor’s degree in a scientific discipline with a minimum of 8 years of directly related experience in biotechnology or within the pharmaceutical industry. The ideal candidate will have good working knowledge of US and Canadian regulations and guidelines, have a sound understanding of the global drug development process and have experience with electronic submissions. 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 Sr. Specialist, Regulatory Affairs provides regulatory support for developing and/or implementing regulatory strategies that support the development, licensure and commercialization of Emergent’s products. Leads the preparation of complex document packages for regulatory submissions, inspections and internal audits as assigned. Required to act as a team leader on department regulatory projects. Interacts with other departments and with multi-discipline project teams as assigned. May provide guidance to other lower level personnel.
DUTIES & RESPONSIBILITIES
- Collaborate in formulating and executing regulatory strategies in a global team setting to support development, registration and post marketing compliance activities for assigned products
- Identify problem areas/regulatory risks and present to Management with developed solutions
- Represents RA on cross-functional teams as assigned
- Provide guidance and interpretation of Regulatory requirements to business stakeholders
- including evaluation of Change Controls
- Provide constructive review of pivotal documentation supporting regulatory applications relative to regulatory requirements as assigned
- Coordinate and prepare routine submissions (e.g. annual reports) and moderate to complex submissions (e.g. BLAs, NDSs, supplemental and Notifiable Change submissions, variations, IND updates, etc) for assigned area of responsibility, both Development and Commercial products
- Lead health agency communications/meetings for assigned products.
- For markets outside of US, Canada and the EU, works with regulatory contact at foreign distributor to facilitate preparation of their marketing application, post-approval submission documents. Coordinate follow up with regulatory contact on their progress with the foreign agency.
- Monitor the progress of agency review of regulatory submissions and follows up with applicable parties. Coordinates, prepares and submits response to Health Authority questions.
- Prepares and reviews any assigned regulatory SOPs.
- Maintains up-to-date knowledge of ICH, FDA, Health Canada and EMEA Regulations
- Understands GXP and the Emergent BioSolutions Quality System
- Mentor regulatory professionals within the Regulatory Department as required
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 scientific discipline (medical, chemical, biological pharmaceutical, biological or other technical field) required. Ideally a minimum of 8 years directly related experience in biotechnology or pharmaceutical industry; minimum 5 years of direct experience in regulatory affairs, including cGMP. Experience may be substituted by advanced education that is relevant to the position responsibilities.
- Is able to carry out complex work in areas of regulatory expertise, with minimal guidance from RA Manager.
- Is able to provide strategic guidance to cross-functional teams, with minimal guidance from RA Manager
- Works within timelines and is adept at priority setting independently; ability to work on multiple projects.
- Is able to identify potential problem areas and bring to attention of RA Manager; is able to develop solutions to potential issues with minimal guidance from RA Manager.
- Good working knowledge of US and Canadian regulations and guidelines, with basic knowledge for other jurisdictions.
- Sound understanding of global drug development process.
- Possesses sound planning skills within areas of regulatory expertise.
- Must have strong technical writing skills. Must be able to summarize technical documents in a manner easily explainable to regulatory authorities.
- Must demonstrate attention to detail.
- Strong communication skills; oral/written and listening with demonstrated ability to build relationships.
- Strong computer skills including Word and Outlook, Excel and PowerPoint.
- Good knowledge of regulatory databases, regulations, guidance’s (US, Canada and other as required).
- Experience with electronic submissions required.
- Core strength in one or more of the following is expected: CMC, Nonclinical, Clinical
- Extensive experience in preparation of submissions (BLAs, NDSs, INDs, CTAs, etc) is required.ADDITIONAL REQUIREMENTS:
- Citizenship/Permanent Resident or Valid Work Permit.
- Successful Completion of a Criminal Record Check.
Interested? Please visit www.emergentbiosolutions.com under careers to apply today!