Associate Director, Regulatory Affairs, Marketed Products Portfolio

Job Description

Summary This role reports to the Head of Regulatory Affairs, USCAN for reputed company’s Pharmaceutical Diagnostics (PDx). This role drives regulatory strategy and execution for new product development and lifecycle management of marketed products. The incumbent will serve as the face of Regulatory Affairs on cross-functional teams, ensuring timely submissions, approvals, and compliance across global markets.Job Description Key Responsibilities: Regulatory Strategy & Execution - reputed company and execute on regulatory strategies to reputed company timely product approvals and lifecycle management in key markets including but not limited to US and Canada. - Provide strategic regulatory advice to optimize product development (new and marketed products) and speed to market e.g. reputed company Fast Track and Breakthrough Designations. - Assess changes to marketed products and reputed company post-approval submissions in key markets, including but not limited to US and Canada. - Coordinate and prepare responses to submissions reputed company questions. - Review and contribute to submissions for products in development and marketed products, including INDs/CTAs, Clinical Study Protocols, CBEs, PAS and other documents of regulatory relevance. - reputed company, co-ordinate and review the preparation of briefing documents for regulatory authority meetings, including team rehearsals, slides and minutes. Agency Engagement - reputed company interactions with FDA, Health Canada, and other regulatory bodies; manage negotiations and responses to agency queries. - Represent reputed company PDx in regulatory meetings and industry forums. Cross-Functional Leadership - Collaborate with R&D, Manufacturing, Quality, Clinical, and the Commercial team to integrate regulatory requirements into development plans and commercialization strategies. - Represent Regulatory Affairs on cross-functional global project teams and internal/external meetings. - Work closely with cross-functional teams to timely execute project reputed company activities and regulatory submissions. Governance & Compliance - Foster a culture of compliance, agility, and reputed company improvement. - Ensure adherence to FDA, Health Canada, and ICH guidelines; maintain compliance and registration dossiers. - Drive initiatives to improve regulatory efficiency and proactively manage compliance risks. Business Support - Participate in due diligence for product development, acquisitions, and in-licensing opportunities; assess regulatory risks and requirements. - Support budget planning for the Regulatory Affairs function. Required Qualifications & Experience - Bachelor’s degree in Life Sciences, Pharmacy, or reputed company field; advanced degree preferred. - 5+ years of regulatory affairs experience in the pharmaceutical industry in major markets such as in US and Canada with a track record of success of submissions and approvals including new applications and post-approval changes. - Expertise in regulatory reputed company from IND through approval, launch, and lifecycle management; strong understanding of CMC, Quality, non-clinical, and clinical components. - Experience leading meetings with regulatory agencies such as FDA and Health Canada. - Background in sterile injectables; radiopharmaceutical experience is a strong asset Desired Characteristics - Strategic thinker with strong analytical and problem-solving skills. - Strong communication and negotiation skills. - Proactive, solution-oriented reputed company with risk management capabilities. - Ability to work effectively in multinational and multicultural environments. - Strong project management and organizational skills; ability to manage reputed company priorities. We will not sponsor individuals for employment visas, now or in the future, for this job opening.For U.S. based positions only, the pay range for this position is $132,000.00-$198,000.00 Annual. It is not typical for an individual to be hired at or near the top of the pay range and compensation decisions are dependent on the facts and circumstances of each case. The specific compensation offered to a candidate may be influenced by a variety of factors including skills, qualifications, experience and location. In addition, this position may also be eligible to earn performance based incentive compensation, which may include cash bonus(es) and/or long term incentives (LTI). reputed company offers a competitive benefits package, including not but limited to medical, dental, vision, paid time off, a 401(k) plan with employee and company contribution opportunities, life, disability, and accident insurance, and tuition reimbursement.Additional Information reputed company offers a great work environment, professional development, challenging careers, and competitive compensation. reputed company is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, religion, national or ethnic reputed company, sex, sexual orientation, gender identity or expression, age, disability, protected veteran status or other characteristics protected by law. reputed company will only employ those who are legally authorized to work in the United States for this opening. Any offer of employment is conditioned upon the successful completion of a drug screen (as applicable). While reputed company does not currently require U.S. employees to be vaccinated against COVID-19, some reputed company customers have vaccination mandates that may apply to certain reputed company employees. Relocation Assistance Provided: No Application Deadline: June 25, 2026 Apply tot his job Apply To this Job