REGULATORY AFFAIRS

Develops treatments that improve the health and lifestyles of patients in various therapeutic areas, particularly those with unmet medical needs. Research and development areas encompass Client targets in neurologic disorders, gastroenterology, cardiovascular therapies, hematology, and metabolic disorders. Our ultimate goal is to identify areas of unmet medical needs and help people live healthy lives.
It is a culture that celebrates diversity and diverse perspectives, and helps its employees achieve an effective balance between work and home life and supports their efforts to have a positive impact on their communities.
The Manager/Director, Regulatory Affairs, will be responsible for developing regulatory strategy and activities related to compounds in development and/or marketed products in the assigned portfolio.

Key Responsibilities Include, But Not Limited To, The Following

·         Develops and implements regulatory strategy.

·         Leads and facilitates cross functional activities related to regional strategy, including providing input on implications of regulatory strategy through participation in product-related teams (e.g., Clinical and Labeling Working Groups and Dossier Submission Teams).

·         Provides regulatory input to CMOs and Marketing Partners.

·         Serves as primary contact with FDA and/or other regulatory agencies.

·         Within the context of the regulatory strategy, determines timing and content for all meetings.

·         Leads and/or participates in meetings with regulatory agencies as appropriate.

·         Prepares company personnel for interactions with regulatory agencies.

·         Ensures that responses to FDA questions are handled in a timely manner and in line with the approved product strategy.

·         Leads and oversees the preparation of dossier content for INDs, BLAs and NDAs according to the strategic plan.

·         Performs critical review of submission documents to ensure compliance with regulatory requirements.

·         Serves as a member of Labeling Working Group (LWG) to derive and update proposed Company Core Data Sheet (CCDS) and US Package Insert (USPI) based on target label.

·         Participates in development of labeling negotiation strategies.

·         Provides input into strategy with respect to clinical study design.

·         Negotiates and manages post-approval commitments.

·         Understands the competitive landscape, e.g., views of HAs, regulatory precedents, and labeling differences.

·         Maintains a working knowledge of laws, guidances, and requirements related to general regulatory knowledge.

Qualifications
To be successful in the role, a candidate is required to possess the following experience and skills:

·         A minimum of a B.S. or undergraduate degree is required. A degree in a life-sciences discipline is highly preferred.

·         An advanced degree (e.g., M.S., Ph.D., PharmD) is preferred.

·         A minimum of 5 years of pharmaceutical, medical device, or health-regulated industry experience with knowledge of the drug development process, regulatory submission, and approval process is required.

·         A minimum of 5 years of experience working in a regulatory affairs function is preferred.

·         An understanding of the drug product lifecycle from discovery to clinical trials to marketing is required.

·         Therapeutic area experience in multiple areas is beneficial.

·         Understanding of FDA and ICH Regulatory requirements and guidelines specific to the areas of clinical research, product development, and labeling is required.

·         Previous experience interacting with health authorities is required.

·         Experience critically reviewing and compiling regulatory documents is required.

·         A previous track record of successfully working within a cross-functional team environment as an individual contributor and as a decisionmaker is required.

·         A proven track record of successfully working within a collaborative team environment and building positive relationships as an individual contributor is required.

·         A previous track record of effectively and successfully prioritizing assignments for multiple projects simultaneously is required.

·         Approximately 10% of domestic travel and international travel may be required.