Proclinical is currently recruiting for a Regulatory Associate with a pharmaceutical company located in Collegeville, PA. In this role the individual is responsible to their line function for the timely production of documentation to manage the development and maintenance of the Global Product Information for Prescribing/Patient/Packaging Information to manage the development of US product information (prescriber and patient)
- Develop and maintain the Global Product Information (PI), in conjunction with functional experts.
- Author of the patient information in the Global Patient Leaflet (GPL).
- Develop and maintain the US product information
- Generate responses to regulatory agency questions related to prescriber and patient information in accordance with policies and procedures.
- Develop and maintain the Global PI, together with support of local product information requires leadership of cross-functional teams and the ability to work with individuals at all levels of the business.
- Authoring the Global Patient Leaflet (GPL) and Global Packaging Component (GPC) of the Global PI.
- Active membership of the Regulatory Matrix Team and submission writing process
- Author responses to labelling questions from regulatory agencies.
Skills and Requirements:
- Life sciences degree, relevant experience or PharmD, PhD or equivalent relevant experience, preferably healthcare professional field.
- Relevant experience includes; regulatory affairs, medical affairs, clinical research, pharmacovigilance, medical information, healthcare.
- Scientific Regulatory Writing - the ability to produce written regulatory scientific communications with clarity, accuracy and rigor.
- Data analysis skills.
- Therapeutic / Product Knowledge.
- Regulatory Knowledge.
- Awareness and application of relevant pharmaceutical regulation and new guidelines/policies relevant to product information.
- Some appreciation of the purpose and scope of pharmaceutical regulation related to product information and maintains an awareness of new external guidelines/policies pertaining to product information.
If you are having difficulty in applying or if you have any questions, please contact Sarah Beshara at 267-477-3355.
ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
Proclinical Staffing is an equal opportunity employer.