Seeking a Forward-Thinking Regulator Affairs Manager. Apply today!
Our client is a unique corporation dedicated to creating novel medicines for the unmet needs of patients with rare diseases. A true pioneer in its field, the company places its considerable scientific resources behind the discovery of compounds that benefit the few. By placing the patient first, our client is able to consider what may be a small commercial success nothing less than a human triumph. Simply put, there is no greater accomplishment than helping the little girl who is suffering from corneal cystinosis or the man with Hodgkin's lymphoma. When you join our client, you’ll embark on an adventure of challenge, discovery and career progression.
Regulator Affairs Manager Gaithersburg, Maryland In this highly versatile role, you will, under direct supervision, identify, implement and revise regulatory plans for assigned projects to ensure the success of development projects and commercially marketed products at all stages in the regulatory process. You’ll work with a variety of products from eye drops to therapeutic, clinical and non-clinical. You will strategize non-clinical, animal and pre-market studies and leverage your familiarity with FDA regulations in striving to move products forward to approval. You will serve as the regulatory representative to project teams in order to ensure compliance with applicable FDA regulations and guidelines. To qualify, you should hold a Bachelor’s degree in a scientific area (a graduate degree is preferred), and possess a minimum of five years of industry or closely related experience in regulatory affairs. Familiarity with labeling and marketing review, along with a keen knowledge of non-clinical (pharmacology/toxicology) or clinical, is expected. You must also be knowledgeable of FDA and ICH regulations and guidelines related to paper and eCTD submissions, and have direct experience in the preparation of maintenance submissions for drug applications (IND, NDA and/or BLA). In addition to outstanding verbal and written communication skills, you must be able to work effectively with others, as you will be writing CTDs (Common Technical Documents), and writing/reviewing content as part of group initiatives. Working with our client, you’ll be rewarded with a competitive salary and full employee benefits, including medical, dental, vision, long- and short-term disability insurance, life insurance, a 401(k) retirement plan, flexible spending, dependent care, generous PTO (paid holidays and vacations), and a free gym membership. What’s more, Gaithersburg, Maryland, offers the convenience of a quick commute to nearby Washington, D.C. Most importantly, you’ll enjoy the intimacy, flexibility and creativity of a small-company culture. Come experience the ultimate reward in a dynamic career—personal, as well as professional—satisfaction! Send your resume and letter of interest for immediate consideration. Be sure to specify “Regulator Affairs Manager – 37314” in the subject line. Our Client is an Equal Opportunity Employer. RCI Recruitment Solutions is a privately owned firm headquartered in Jupiter, Florida, with operations throughout the United States. For almost 40 years, RCI has provided a wide range of candidate sourcing and related recruitment services. Its proprietary and client-specific solutions encompass a variety of services, including advertising, consulting, media services, and staffing technology.