Director of Labeling & Promotional Review

Description

  Zydus Therapeutics is a clinical stage, specialty-focused bio-pharmaceutical company focused on developing transformative treatments to transform lives, starting with rare and serious liver diseases and anemias.

Our purpose is simple, to empower people with the freedom to live healthier and more fulfilling lives, by unlocking new possibilities in life sciences and providing quality healthcare solutions.

Our lead drug candidate, Saroglitazar, is a liver-selective, dual peroxisome proliferator-activated receptor (PPAR) alpha / gamma agonist. Saroglitazar is an investigational treatment which has received Fast Track designation and orphan drug designation from the US Food and Drug Administration (FDA) for the treatment of patients with primary biliary cholangitis (PBC). Saroglitazar is also an investigational treatment in development for the treatment of non-alcoholic steatohepatitis (NASH). Our second drug candidate is Desidustat, an oral hypoxia-inducible factor prolyl hydroxylase (HIF- PH) inhibitor, an investigational treatment in development for the treatment of chemotherapy-induced anemia (CIA). As a wholly-owned subsidiary of Zydus Lifesciences, our pipeline is fueled by 1,300 researchers who are working with cutting-edge technologies to discover new medicines for tomorrow. 

Zydus Therapeutics, Inc. is seeking a candidate for the role of Director of Regulatory Labeling, Advertising, and Promotion who will oversee U.S. product labeling and promotional regulatory activities across the company’s portfolio. This position provides strategic/operational leadership to ensure promotional materials and labeling are scientifically accurate, FDA-compliant (OPDP), and aligned with corporate objectives.

RESPONSIBILITIES: 

• Ensure that advertising, and promotional materials meet applicable advertising and promotion regulations.  Ensure that medical affairs materials meet applicable regulations.  

• Oversee the development, maintenance, and lifecycle management of core labeling documents, including USPI and patient information leaflets.

• Partner with Supply Chain, Commercial, Medical, Legal, Compliance, and Regulatory Operations teams to effectively and efficiently build regulatory compliance into product labeling distribution, marketing and medical strategies and execution. The Regulatory Operations team is based in India.

• As the regulatory lead on the Promotional and the Medical Review Committees, design and optimize Medical & Legal Review (MLR) processes for Promotional and for Medical Affairs pieces, SOPs, and Review Committee operations to strengthen compliance and efficiency.

• Be the point of contact with OPDP, preparing advisory requests, 2253 filings, and engaging in enforcement risk management.

• Provide strategic regulatory input on claims, safety information, and labeling changes, assessing their impact on promotional materials and overall communication strategy.

• Train internal teams on FDA enforcement trends, guidance updates, and best practices.

Requirements

QUALIFICATIONS – SKILLS & REQUIREMENTS: 

• Deep understanding of advertising, medical affairs, and labeling regulations, FDA OPDP expectations, and enforcement trends.

• Ability to balance compliance with marketing innovation, translating complex regulations into actionable guidance.

• Experience in streamlining review cycles while reducing risk of enforcement action.

• Strong collaboration skills across cross-functional and external (e.g., FDA) stakeholders.

• Ability to effectively assess and communicate risk to inform strategic decisions.

EDUCATION & EXPERIENCE: 

• 10+ years of regulatory affairs experience in the biotech or pharmaceutical industry, with at least 5 years in labeling and promotional review, preferably with experience in product launch and/or accelerated approval product.

• Deep knowledge of FDA regulations on labeling, promotion and new drug applications (21 CFR Parts 201, 202, 314).

• Proven track record of leading cross-functional promotional review committees (PRC/MRC).

• Proven track record of translating complex regulatory requirements into actionable language and guidance.

• Strategic mindset with the ability to communicate risk effectively and balance compliance with business objectives.

TRAVEL: 

• Limited travel required.

WORK ENVIRONMENT: 

This is preferably a hybrid office-based position, located in our office in Princeton, NJ.  Alternatively, this position may be remote, but from time to time or when required, the employee will be required to report to our office. The physical demands described here are representative of those that must be met by an individual to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this job, the individual is:

• Frequently required to sit and/or stand, walk, talk, and hear.

• Ability to sit at a computer for an extended period of time.

• Vision ability requirements include clarity of visions at 20 inches or less due to computer work.

• Moderate noise (i.e., background noise due to computers, phone, printers, and light hallway traffic).

• Constantly required to use hands and fingers to operate office machines and equipment.

• Frequently required to reach with hands and arms. Occasionally required to stoop, kneel, and crouch.

The work environment characteristics described here are representative of those that an individual encounters while performing the essential functions of this job. 

Zydus Therapeutics provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws. Zydus is committed to providing reasonable accommodation to, among others, individuals with disabilities and disabled veterans. If you need an accommodation because of a disability to search and apply for a career opportunity with Zydus, please contact us and let us know the nature of your request.