Work closely with the Head of Regulatory Affairs to provide regulatory leadership for product development, sales, marketing, and manufacturing and implement regulatory strategies for required programs and products. Maintain registration documents relating to all Almirall marketed products and development activities. This position requires flexibility and a strong overall understanding of all regulatory affairs associated with a pharmaceutical company with marketed and investigational products.
Supports the Head of Regulatory Affairs in the development of effective, proactive regulatory strategies for product development, labeling or promotional issues, and recommends such strategies to Almirall Team Members and/or management, as appropriate
Responsible for implementing and/or executing regulatory strategies as assigned
Serves as FDA point of contact and responsible signatory for FDA submissions, as assigned
Manages submissions to regulatory agencies, including FDA (e.g. NDA filings and supplemental applications, INDs, IND Annual Reports, Meeting Requests, Briefing documents, and other submissions). Includes developing and maintaining timelines for dossier preparation, authoring/ reviewing and compiling documents, and coordinating with contractors to ensure high quality submissions are completed on time.
Responsible for the review and approval of promotional materials and labeling in cooperation with cross-functional teams for FDA approved products, as assigned
Provides regulatory support to resolve issues and provide assistance to Manufacturing, QA/QC and Sales/Marketing, on an as needed basis. Includes review and approval of manufacturing changes through change control process with contract manufacturing sites.
Insures that all Regulatory Affairs activities and contractors are managed in an appropriate manner to comply with all of the Company's budgetary objectives. Manages/reviews all work of regulatory affairs contractors and maintains official Regulatory Files for Almirall.
Reviews and approves all scientific and technical protocols and reports required for regulatory submission to the appropriate authority
Maintains thorough knowledge of the laws, regulations and guidelines covering the conduct of clinical trials in the U.S. and post approval regulatory requirements for promotion, pharmacovigilance, and application maintenance. Also maintains a solid working knowledge of regulations regarding the nonclinical and clinical development requirements for investigational products.
REQUIRED EDUCATION AND EMPLOYMENT QUALIFICATIONS
B.S. or B.A. in Pharmaceutical or related sciences with at least 5 years of experience in Regulatory Affairs
Excellent written and verbal communication skills and the ability to manage multiple projects and competing priorities are essential
This position has a high level of complexity. The incumbent must be able to support regulatory activities for currently marketed products and new product development processes both inside and outside of the company and assist in prioritizing related activities to ensure that objectives are successfully met in a timely manner.
This position has a high level of interaction both internal and external to the Company. The incumbent must be capable of interacting with and influencing Almirall leadership, governmental agencies and third party consultants on a regular basis. This position is required to represent the Company on assigned regulatory matters.
The individual in this position handles highly confidential information regarding the Company’s internal documents involved in the product development and commercialization process
Almirall was founded in Barcelona, Spain, in 1943, and now operates in 21 countries through 13 affiliates with a portfolio of 40 products marketed across various geographies. A family company, we are focused on medical dermatology and skin health. Our US organization was acquired by Almirall S.A. in 2013, and is headquartered in Exton, Pennsylvania.
We invest heavily in R&D with nearly 14% of sales revenue and employees devoted to achieving our goal of being a leader of innovation in medical dermatology. Almirall strives every day to turn our expertise into real solutions. Through science, research & development, discovery agreements and alliances, we are building solid partnerships driven by the shared goal of discovering medical solutions to improve the lives of patients.