Proclinical is currently recruiting for a Regulatory Associate with a pharmaceutical company located in Rockville, MD.
- Provide support to the GRL to assure efficient interactions with the regulatory authorities to achieve on-time approvals of Vaccines submissions for the asset(s).
- Assess the regulatory impact of Regulatory Facilities related Changes pertaining to approved commercial products.
- Be aware of changes in regulatory guidelines and their impact on regulatory strategy for the particular asset(s).
- Provide support to the Global Regulatory Lead (GRL) for key regulatory activities pertaining to a project/product.
- Interact with internal project related teams, for Facilities related regulatory affairs aspects of a given project on technical aspects.
- Participate in project/product-related discussions and provide strategic, scientific and regulatory affairs input, for Facilities related aspects of given project on technical aspects.
- Provide input into the asset specific regulatory strategy on a global scale.
- Provide support to the GRL via input and/or critical review of the facilities regulatory documents, Global Regulatory Plan(s) and/or Key Message Summaries.
Skills and Requirements:
- Bachelor's degree (Science) or advanced degree.
- 6+ years significant experience in regulatory affairs or appropriate relevant experience in scientific function combined with at least 3 years direct RA experience.
- Knowledge and experience in US regulations pertinent to CMC Establishments/GMP.
- Knowledge and experience in CMC Establishments/GMP/ Equipment Validations.
- Pharmaceutical development or regulatory affairs experience with biologics and vaccines preferred.
- Preferred experience in providing strategic advice on integrated regulatory development plans and life cycle management, preferably for the US. Providing US-focused input into regulatory strategy, evaluating potential impact on overall project/product strategy.
- Preferred experience in identifying and escalating regulatory or programmatic issues while proposing mitigations strategies and solutions/problem solving. Developing plans and timelines for complex projects and collaborating with other departments and teams in the delivery of outputs in a timely manner. Forming collaborative relationships and having high impact and influence on multicultural, diverse, and/or international teams.
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.