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Job type: Permanent

Discipline: Officer /Associate, Project Manager, CMC

Location: United States

Proclinical is currently recruiting for a Regulatory Associate with a pharmaceutical company located in Rockville, MD.

Job Responsibilities:

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.

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