Job added in hotlist
Applied job
Contract job
Recruiter job
Employer job
Expanded search
Apply online not available
Similar Jobs
Associate Director, Real World Value and Evidence, Immunology
Johnson & Johnson Services, Inc.
Horsham, PA
Apply Now >
Environmental Scientist
Environmental Strategy Consultants, Inc.
Philadelphia, PA
Apply Now >
Associate Director Clinical Project Scientist
Johnson & Johnson Services, Inc.
Spring House, PA
Apply Now >
Senior Scientist - Bioanalytical Separations
Glaxosmithkline Inc
King of Prussia, PA
Apply Now >
Downstream Process Development Lead
Spark Therapeutics, Inc.
Philadelphia, PA
Apply Now >
View more jobs in King Of Prussia, PA
View more jobs in Pennsylvania
View Similar Jobs

Job Details

Regulatory Scientist

Company name
CSL, Ltd.

King of Prussia, PA

Apply for this job


The Regulatory Scientist, is responsible for all regulatory strategic and operational tasks for a range of investigational and licensed products. Proposes or contributes to regulatory strategies, contributes to their execution and closely cooperates with other regulatory functions and, as applicable, regional and local regulatory managers regarding new license applications for development products and for relevant change applications with a view to obtain HA approval in the fastest and most efficient way while ensuring compliance with the regulatory requirements pertaining to product approval and license maintenance. Serve as Regulatory Scientist, for one or more programs\/projects. Propose regulatory strategies considering regulatory requirements, classification of changes, scheduling and priority setting. Under supervision of the Team Lead \/ TA Lead ensure all regulatory activities are in alignment with the strategic direction of the GRAST. Contribute to a GRA Strategy Document for complex projects and provide review of regional regulatory strategies. Monitor timelines Participate in GRASTs, as applicable. Contribute to a submission schedule for each product, reflecting all scheduled submissions, e.g. new license applications, commitments, variations, renewals, clinical trials, pediatric plans, orphan drug designations, product identifiers \/ names, periodic safety reports etc. Contribute to the compilation of relevant high quality documentation for submissions, including applications for new licenses, variations, license renewals, responses to questions, clinical trials, pediatric plans, orphan drug designations, product identifiers\/names, DSURs and changes according to agreed schedules while taking into account regional specific requirements. This comprises also related responses to questions of the submissions. Ensure that dossiers meet the content and format requirements for relevant regulatory authorities via effective communication with the Team Lead\/TA Lead, Regional Regulatory Affairs Manager\/Local Regulatory Affairs Manager (RRM\/LRM), GRLs and other GRAST members. Creates check-lists of required documentation, ensures the timely submission readiness of documents and tracks availability of all required documents. Performs or contributes to regulatory procedures like new license applications, renewal applications, change applications, period safety reporting submissions, submissions of other documents required to fulfill regulatory post approval commitments and international Scientific Advice meetings. In a timely manner, place the relevant regulatory documentation at the disposal of other GRA Functions, the Regional Regulatory Affairs Manager\/Local Regulatory Affairs Manager (RRM\/LRM) or submit to the Health Authorities, as applicable. Communicate submission dates and approval dates to stakeholders, as applicable. Coordinate the development of responses to HAs for the respective GRA Function, as applicable. Support Global Regulatory Strategy Team (GRAST) members for the strategy, planning and preparation of regulatory documents Coordinate and participate at Scientific Advice Meetings under supervision of EU Regulatory Affairs Franchise\/TA Lead. Education and Qualifications: A degree in Life science (at least BSc) or Medical Science or Pharmacy, preferably with a post-graduate qualification. Degree e.g. in Drug Regulatory Affairs advantageous. Regulatory experience in a biotech or plasma protein company is an advantage. Understanding of the scientific principles and technical requirements relevant to the development of a pharmaceutical product. Understanding of the principles of GMP, GCP and GLP. Strategic and tactical thinking ability, complemented by a \u201chands on\u201d operational approach and business planning orientation. Ability to identify the \u2018big picture\u2019 and opportunities\/major issues and link day to day tasks with long term goals. Demonstrated ability to deal with rapid change. Demonstrated sound judgment and flexible approach to managing situations. Customer service focus. Worker Type:Employee Worker Sub Type:Regular

Company info

CSL, Ltd.
Website :

Company Profile
The CSL Group of companies develops, manufactures and markets pharmaceutical products of biological origin.

Similar Jobs:
job title scientist director pharmacovigilance
Location : King of Prussia, PA
Job ID 2018-1747 # of Openings 1 Category Pharmacovigilance Overview The Medical Director: This role will participate in oversight of all post-marketing and clinical safety and pharmacovigilance activities. Will ensure timely, c...
Safety Scientist UBC
Location : Philadelphia, PA
Brief description: This position is primarily responsible for supporting all operational functions within the Pharmacovigilance Department including, but not limited to, client interface and deliverables, individual case safety ...
Scientist Application Chemist
Location : Fort Washington, PA
Join a team recognized for leadership, innovation and diversity Honeywell Performance Materials is a global leader in developing and manufacturing advanced materials, process technologies and automation solutions. PMT\u2019s Adv...
EmploymentCrossing is great because it brings all of the jobs to one site. You don't have to go all over the place to find jobs.
Kim Bennett - Iowa,
  • All we do is research jobs.
  • Our team of researchers, programmers, and analysts find you jobs from over 1,000 career pages and other sources
  • Our members get more interviews and jobs than people who use "public job boards"
Shoot for the moon. Even if you miss it, you will land among the stars.
ScientistCrossing - #1 Job Aggregation and Private Job-Opening Research Service — The Most Quality Jobs Anywhere
ScientistCrossing is the first job consolidation service in the employment industry to seek to include every job that exists in the world.
Copyright © 2018 ScientistCrossing - All rights reserved. 21