- Serve as key corporate regulatory contact and source of regulatory information and guidance for US and other markets as applicable; may serve as US Agent.
- Serve as a line manager: constructing and developing a team (as resources are assigned)
- Provide strategic, tactical, and operational direction and guidance for product's pipeline and key regulatory milestones.
- Responsible for developing, executing, and maintaining the regulatory commitments and requirements for assigned programs.
- Stay abreast of regulatory agency regulations, directives, guidelines and policies, etc. that could have an impact on product development to assess approval pathways and issues.
- Identify and communicate all issues to management related to product development that could impact product submission, approval, and product launch.
- Set and monitor submission timelines along with other key stakeholders.
- Facilitate and lead all communications with Regulatory Agencies / Health Authority as applicable.
- Ensure communication with the regulatory body is in accordance with established procedure within the department.
- At times, there may be the need for other functional areas to have a discussion with the Health Authority with their counterparts at the regulatory agency. The Regulatory Strategist/Lead should always be the point of contact and lead this interaction.
- Ensure that communication that is documented per established procedure should be distributed within the Global Regulatory Affairs team and any other external department that is directly affected by the communication.
- Must be involved in writing or to facilitate the authoring of certain regulatory sections of product submissions.
- Develops and manages relationships with external regulatory agencies, industry groups and business partners.
- As applicable, shall review the audit reports, Regulatory Agency inspection reports and responses to the inspection observations if any, when received.
- To compile, prepare, and review regulatory submissions to regulatory agencies as applicable.
- Conduct department level training, as necessary, to educate regulatory strategists and other roles in the department on regulatory requirements, policies, and procedures.
- Participate in authoring and/or reviewing of the departmental procedure as applicable.
- Extensive global regulatory leadership as demonstrated by experience (> 15 years), milestones reached (e.g., original/supplemental approvals, expedited program designations), and health authority engagements (e.g., FDA, EMA, and others)
- Strong staff and organizational development experience (e.g., building teams, and coaching and training both new and experienced staff); demonstrated strengths in delegation, resource allocation, and workload prioritization.
- Broad experience in and across regulatory disciplines (notably global/regional strategy, labeling, clinical, nonclinical, CMC)
- Direct experience and expertise in authoring and filing regulatory documentation across major regulated markets.
- Ability and interest in building and/or working a nimble resourcing environment.
- Advanced degree preferred (PhD, MD, PharmD, MBA, JD)
-
Specialist - Regulatory Affairs
1 week ago
Novo Nordisk Plainsboro, United States**About the Department*** · The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one of the most diverse and collaborative groups within the organization. From health-care-provider interactions and developing and implementing regulatory strategies with the FDA ...
-
Regulatory Affairs Analyst
1 week ago
Freyr Princeton, United StatesRegulatory Affairs Analyst (Master's or equiv. degree w/1 yr. exp.) Princeton, NJ. Exp. in: manage & coordinate regulatory affairs team; implement regulations for preparation & submission of regulatory documentation; risk management planning & traceability matrix; submitting docu ...
-
Director of Regulatory Affairs
2 weeks ago
BioPhase Princeton, United StatesHybrid - 3 days a week in office - Princeton, NJ · The Associate Director of Regulatory Affairs Labeling will assist in the development of a cross-functional labeling strategy for products worldwide, including providing expert input on labeling requirements and strategic guidanc ...
-
director regulatory affairs
3 days ago
TK-CHAIN LLC Princeton, United StatesSUMMARY OF POSITION The Director, Regulatory Affairs integrates and applies knowledge of US regulatory guidelines and federal regulations governing pharmaceutical drug development to all aspects of Our Client's 's drug development programs, policies and procedures; ensuring a com ...
-
Regulatory Affairs Associate
5 days ago
Laboratoire Guerbet Princeton, United StatesAt Guerbet, we build lasting relationships so that to enable people to live better. This is Our Purpose. · We are a global leader in medical imaging, offering an extensive portfolio of pharmaceuticals, medical devices, digital and AI solutions, for diagnostic and interventional ...
-
Regulatory Affairs Associate
2 days ago
Laboratoire Guerbet Princeton, United StatesAt Guerbet, we build lasting relationships so that to enable people to live better . This is · Our Purpose. · We are a global leader in medical imaging, offering an extensive portfolio of pharmaceuticals, medical devices, digital and AI solutions, for diagnostic and interventio ...
-
manager regulatory affairs
2 days ago
TK-CHAIN LLC Princeton, United StatesJob Description · Job Description · SUMMARY OF POSITION · Manages team and leads Regulatory Associates and/or Senior Regulatory Associates in regulatory activities associated with planning, authoring, compiling and submitting highest-quality regulatory submissions to the FDA with ...
-
Senior Regulatory Affairs
1 week ago
Diverse Lynx Princeton, United StatesHi, · Welcome to Diverse Lynx We combine industry leading expertise and our personal dedication to help you find your next career opportunity. We are a Minority and Women Owned Business Enterprise (MWBE) certified by the State of New Jersey and Minority Business Enterprise (MBE) ...
-
director regulatory affairs
2 days ago
TK-CHAIN LLC Princeton, United StatesJob Description · Job DescriptionSUMMARY OF POSITION · The Director, Regulatory Affairs integrates and applies knowledge of US regulatory guidelines and federal regulations governing pharmaceutical drug development to all aspects of Our Clients s drug development programs, polici ...
-
Director Regulatory Affairs
4 days ago
Lynkx Staffing LLC Princeton, United StatesJob Description · Job DescriptionOur Pharmaceutical client is seeking a Director Regulatory Affairs Chemistry Manufacturing & Controls (CMC) to guide global teams through the development and execution of regulatory strategy and the design of CMC components of drug development pro ...
-
Regulatory Affairs Intern
3 weeks ago
Dr. Reddy's Laboratories Inc. Princeton, United States OTHERAt Dr. Reddy's "Good Health Can't Wait" · By joining Dr. Reddy's, you will contribute to making the breakthroughs of tomorrow a reality today From making medicines more affordable to discovering innovative treatment options to satisfy unmet medical needs, we are dedicated to help ...
-
Regulatory Affairs Intern
3 weeks ago
Dr. Reddy's Laboratories Inc. Princeton, United States OTHERAt Dr. Reddy's "Good Health Can't Wait" · By joining Dr. Reddy's, you will contribute to making the breakthroughs of tomorrow a reality today From making medicines more affordable to discovering innovative treatment options to satisfy unmet medical needs, we are dedicated to he ...
-
Specialist - Regulatory Affairs
1 week ago
Novo Nordisk A/S Plainsboro, United StatesProvide proactive support and technical assistance to more experienced regulatory personnel. Identify issues and inform appropriate individuals. Ability to work with less supervision than Associate. Take initiative to assist with overflow in other ar Regulatory Affairs, Regulator ...
-
Specialist - Regulatory Affairs
2 days ago
Novo Nordisk Plainsboro, United StatesAbout the Department · The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one of the most diverse and collaborative groups within the organization. From health-care-provider interactions and developing and implementing regulatory strategies with the FDA to ...
-
Specialist - Regulatory Affairs
1 day ago
Novo Nordisk Plainsboro, United StatesAbout the DepartmentThe Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one of the most diverse and collaborative groups within the organization. From health-care-provider interactions and developing and implementing regulatory strategies with the FDA to prov ...
-
Specialist - Regulatory Affairs
1 week ago
Novo Nordisk Plainsboro, United States Full timeAbout the Department · The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one of the most diverse and collaborative groups within the organization. From health-care-provider interactions and developing and implementing regulatory strategies with the FDA to ...
-
Regulatory Affairs Specialist Ii
1 week ago
Katalyst Healthcares & Life Sciences Inc Edison, United States**Responsibilities**: · - This position is responsible for the preparation of regulatory submissions required to market medical devices in both the U.S. and Europe, support of international product registrations and related regulatory affairs activities, including execution of pr ...
-
Senior Director Regulatory Affairs
1 week ago
Sun Pharma Princeton, United StatesThe Brands and Innovative Medicines Global Regulatory Affairs organization is seeking a Senior Director, Global Regulatory Portfolio Leader. Working with leaders across the organization, this individual will provide leadership for the regulatory strategy of one or more in-line an ...
-
Senior Director Regulatory Affairs
3 days ago
Sun Pharma Princeton, United StatesSenior Director, Regulatory Affairs - GDP · Shionogi Inc. · posted 05/06/2024 · More... · front runner · Senior Director, Regulatory Affairs CMC · Meet · Philadelphia, PA 19117 · posted 05/09/2024 · More... · front runner · Senior Director Regulatory Affairs · Sun Pharma ...
-
senior manager regulatory affairs
1 week ago
TK-CHAIN LLC Princeton, United StatesSUMMARY OF POSITION The Sr. Manager, Regulatory Affairs integrates and applies knowledge of US regulatory guidelines and federal regulations governing pharmaceutical drug development to all aspects of Our Client's 's drug development programs, policies and procedures; ensuring a ...
Senior Director Regulatory Affairs - Princeton, United States - SUN PHARMA
Description
The Brands and Innovative Medicines Global Regulatory Affairs organization is seeking a Senior Director, Global Regulatory Portfolio Leader. Working with leaders across the organization, this individual will provide leadership for the regulatory strategy of one or more in-line and pipeline assets in one or more therapeutic areas and develop a team of US and/or global regulatory leaders (as assigned). Where possible, and leveraging contemporary mechanisms, a key goal for the role is to ensure the conceptualization, development and implementation of efficient global registration pathways to secure approval as well as maintain and (potentially) expand licenses in one and (typically) more geographies. The role will be a key member of the Global Regulatory Affairs Leadership Team, reporting directly to the VP/Head, Global Regulatory Affairs.
Primary Responsibilities:
Qualifications:
Education: