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Director, Regulatory Affairs Lifecycle Management

Posted Jul 08
Contract
Bridgewater, New Jersey

ID: 822

Date of Posting: Jul 8, 2024

Job Family: Regulatory Affairs

Job Type: Direct Employee

On site / Remote / Hybrid: On Site

Location:

Bridgewater, NJ, US

Territory

Shift: Full Time

Seniority: Director

_With its beginnings in a family run pharmacy in Correggio, Italy in the 1920s, Recordati is now a global pharmaceutical force, listed on the Italian stock exchange, with over 4,300 employees.

We are a group of like-minded, passionate individuals who go to extraordinary lengths for our partners, customers, investors and the people across the globe who we serve. We develop and commercialise medicines to serve people living with common diseases, as well as those living with some of the rarest, in around 150 countries.

At Recordati, our mantra is simple. We’ve always believed that health, and the opportunity to live life to the fullest, is a right, not a privilege. Whether that is for common diseases or the rarest – we want to give people the opportunity to be the best version of themselves.

This drive will never stop. Together, we will always be reimagining tomorrow – with new ideas, new technologies and new innovations to fight diseases.

Recordati. Unlocking the full potential of life.

_ 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 devastating rare diseases, focusing on providing often overlooked treatments to underserved communities in the U.S. Our mission is to mitigate the impact of rare diseases through increased awareness, improved diagnoses, and enhanced treatment availability, covering endocrinology, metabolic, and oncology franchises. RRD is dedicated to excellence, fostering a dynamic work environment that promotes professional growth and a significant impact on patients' lives.

Reporting Structure

Reports To: Vice President, NA Regulatory Affairs and Quality Assurance (GCP/GPV)

Direct Reports: Regulatory Affairs Specialist and Associates

Areas Managed: Regulatory Affairs Lifecycle Management

Overview

  • Lead RRD Regulatory Affairs Lifecycle Management for US and Canada, including development and implementation of the overall regulatory strategy, preparation of regulatory submissions and interface with relevant health authorities, and assurance that promotional labeling and communications are in compliance with applicable regulations.
  • Establish and maintain the Company’s regulatory policies and procedures pertaining to post-approval reporting commitments to ensure that all company activities (in-house and outsourced) are done in full compliance with all applicable regulatory guidelines.

Essential Duties And Responsibilities

  • Develop and implement regulatory strategies supporting lifecycle management for US and Canada.
  • Assess data and oversee assembly of documentation to support lifecycle management submissions.
  • Liaise with regulatory authorities as needed pertaining to product lifecycle management.
  • Manage cross-functional review process to ensure that advertising, promotional labeling, training materials, and communications are compliant with FDA regulations and guidance documents.
  • Oversee submission of advertising and promotional material to the FDA as required.
  • Support and/or direct 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.
  • Oversee and track marketing authorization (MA) renewal 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.
  • Support business objectives with regulatory strategic support and due diligence as required.
  • Perform additional duties as may be assigned.

Education And Experience

  • Bachelor’s degree required; master’s or doctoral degree in the life sciences strongly preferred.
  • At least 15 years’ experience in Regulatory Affairs; ideally with managerial experience.
  • 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 guidances; 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.
  • Experience with third-party contract manufacturing organizations (CMO) is preferred.
  • 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 20% 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 on the basis of any characteristic protected by federal, state, or local law. Recordati Rare Diseases will provide reasonable accommodate for qualified individual 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.

_At Recordati we believe in people! Inspired by our purpose - unlocking the full potential of life - we are committed to creating a diverse environment and cultivating a culture of inclusion. We strive to continually lead with our values and beliefs, enabling our employees to bring their whole selves to work and develop their potential.

_ _We are proud to be an equal opportunity employer. We recruit, develop and reward without regard to, amongst others, gender, sexual orientation, gender identity or expression, national origin, age, physical or mental ability, race, ethnicity, political or religious belief.

_ If you are looking to join a company where you can try new things, speak openly, and be bold, we invite you to apply today.