Regulatory Affairs Manager

This position is with Recordati Rare Diseases, Inc. (RRD), North America, an affiliate of Recordati.

Recordati Rare Diseases, Inc. (RRD) develops high-impact therapies for rare diseases, focusing on providing treatments to underserved communities in the U.S. Our mission is to mitigate the impact of rare diseases through increased awareness, better diagnoses, and improved treatment access in endocrinology, metabolic, hematology and oncology franchises. RRD is dedicated to fostering a dynamic work environment that promotes professional growth and a significant impact on patients' lives.

Reporting Structure

Reports To:    Senior Director, Regulatory Affairs, Strategy and Lifecycle Management
Direct Reports:    N/A
Areas Managed:    Regulatory Affairs

Overview

•    Manage RRD Regulatory Affairs for assigned products for US and Canada, including implementation of the overall regulatory strategy, preparation of regulatory submissions and interface with relevant health authorities.

Essential Duties and Responsibilities

•    Implement regulatory strategies supporting drug development and lifecycle management for US and Canada.
•    Review documentation and prepare lifecycle management submissions.
•    Review documentation and prepare drug development activity of pre-IND and IND submissions.
•    Liaise with regulatory authorities as needed pertaining to drug development and product lifecycle management.
•    Oversee submission of advertising and promotional material to the FDA as required.
•    Support the labeling and/or change control processes to ensure timely and comprehensive review.

•    Maintain labels/labeling for newly acquired and existing products in compliance with regulatory requirements and company standards.
•    Track Annual Report and Periodic Safety Update Reports (PSUR) schedules to ensure that required dossiers are prepared and submitted as required.
•    Coordinate with Medical Affairs & Pharmacovigilance to ensure timely reporting of safety data to regulatory agencies and partners.
•    Ensure compliance with all federal regulations regarding post-marketing reporting to the FDA and other health authorities.
•    Act in full compliance with all laws, regulations, and policies including adverse events / pharmacovigilance responsibilities.
•    Perform additional duties as may be assigned.

Education and Experience

•    Bachelor’s degree required; advanced degree in the life sciences preferred.
•    A minimum of 5 years’ experience in Regulatory Affairs
•    Experience in a commercial-stage organization required.
•    Demonstrated ability to deliver quality results within a fast-paced, dynamic environment.

Knowledge and Skills

•    Knowledge of current FDA and Health Canada regulations and guidance; and knowledge of and experience with pharmacovigilance and related drug safety reporting regulations.
•    Ability to manage multiple priorities and regulatory submissions at different stages as required.
•    Strong project management skills with proven ability to drive projects through to completion.
•    Working knowledge of Veeva platform helpful but not required.

Work Environment

This job operates in a professional office environment. This role routinely uses standard office equipment such as computers, phones, photocopiers, filing cabinets and fax machines. Based upon job requirements, employee may be required at times to attend meetings including travel out of state over weekends and nights. Employee must be able to freely operate and travel by car and train/plane modes of transportation. Employee is required to have a valid driver’s license and means of transportation.

Physical Demands

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. The employee must be able to fly via commercial air carrier.

This is largely a sedentary role; however, the employee frequently is required to stand; walk; use hands to finger, handle or feel; and reach with hands and arms; talk and hear. Occasionally is required to lift and/or move light to moderate weight up to 25 lbs.

Location/Travel

•    This position is located at RRD’s US headquarters in New Jersey.
•    Approximately 10% travel (domestic and international) required.

FLSA Classification

•    This position is considered Exempt.

EEO Statement

It is the policy of Recordati Rare Diseases to provide equal employment opportunity (EEO) to all persons regardless of race, color, religion, sex, sexual orientation, gender identity, or national origin. Further, Recordati Rare Diseases will not discriminate based on any characteristic protected by federal, state, or local law. Recordati Rare Diseases will provide reasonable accommodation for qualified individuals with disabilities.

Disclaimer

This job description is not designed to cover or contain a comprehensive listing of the activities, duties or responsibilities that may be required.