Associate Director Regulatory Labeling Strategist
Found in: Appcast US C2 - 2 weeks ago
The Labelling Strategy Associate Director provides regulatory labelling expertise, typically for more complex drug projects, to the Global Regulatory Submission Team (GRST)/Global Regulatory Execution Team (GRET), and cross functional Product Labelling Teams (PLT). This individual leads the development/implementation of the labelling strategy and maintenance of Core Product Information and United States (US) /European Union (EU) Market Product information (MPI) for assigned client (Client) marketed or pipeline products.
Responsibilities :
Ensures that the labelling process is followed through the lifecycle of the product.
Ensure all work is performed in accordance with established procedures, regulatory requirements and GxPs.
Leads the development of the labelling strategy, in line with the overall regulatory strategy for the product, by interpretation of regulations, guidance and competitor analyses, anticipating and communicating the wider impacts of the strategy and the long-term consequences for the product and the wider Client portfolio.
Leads the PLT in the preparation and maintenance of high-quality Core Prescribing Information, EU Quality review of Documents (QRD), US Prescribing Information (PI), Instructions For Use (IFUs) through to Senior Leader approval with the aim of achieving advantageous labelling.
Leads the development of labelling negotiation strategies, anticipating HA perspectives.
Provides labelling expertise for assigned products regarding language, placement and regulatory content detail for CPI and MPI in line with company procedures, regional labelling regulations and guidance.
Provides clarity regarding applicable labelling requirements and expectations in complex situations to relevant stakeholders, including risk insight and proposing mitigations
Evaluates, interprets and communicates global regulations and trends on labelling and any business impact these might have on product labelling
Ensures appropriate communication across Labelling subfunctions
Able to justify and communicate the labelling rationale to Senior Leaders to enable effective decision making.
Leads the development of target labelling documents as appropriate
Minimum requirements :
University Degree in Science or related discipline
5 years pharmaceutical experience, including regulatory experience, preferably working with labelling
Knowledge of labelling regulations and guidance
Excellent verbal and written communication skills
Keen attention to detail and accuracy
Multi-cultural awareness and sensitivity; demonstrated experience effectively communicating and negotiating in diverse cultures.
Ability to assimilate clinical and scientific information and present it in a concise manner
Ability to think strategically, appropriately assess risks and formulate strategies to manage risk
Must demonstrate competencies in:
Building Relationships (works well across formal and informal networks)
Negotiation Skills (good listener; able to build a consensus)
Critical Information Seeking (works well across formal and informal networks)
Rational Persuasion (able to distil an issue to its key components and suggest solutions)
Interpersonal Awareness (aware of how actions affect other people)
-
Associate Director, CMC Regulatory Affairs
6 days ago
Gaithersburg, United States WORK180 USA Full timeAssociate Director, CMC Regulatory Affairs The most difficult thing is the decision to act, the rest is merely tenacity. The role holder will have the appropriate level of CMC Regulatory Strategy, Operational, tactical, and decision-making expertise for projects and sophisticated product ranges from the development phase through to global launch and...
-
Associate Director, CMC Regulatory Affairs
Found in: Jooble US O C2 - 1 week ago
Gaithersburg, MD, United States Work180 Full timeAssociate Director, CMC Regulatory Affairs The most difficult thing is the decision to act, the rest is merely tenacity. The role holder will have the appropriate level of CMC Regulatory Strategy, Operational, tactical, and decision-making expertise for projects and sophisticated product ranges from the development phase through to global launch and...
-
Gaithersburg, United States AstraZeneca Full time**CMC RA Associate Director Project Leadership** Are you ready to turn our pipeline into reality and impact unmet patient needs? We are seeking a CMC RA Associate Director Project Leadership to join our Oncology R&D team. The role holder will have the appropriate level of CMC Regulatory Strategy, Operational, tactical, and decision-making expertise for...
-
Gaithersburg, United States AstraZeneca Full time**Associate Director Clinical Pharmacology and Pharmacometrics (Clinical Pharmacology)** Introduction to Role: Are you ready to make a meaningful impact on patients' lives? We are looking for an Associate Director Clinical Pharmacology to join our dedicated Research & Development team in the Biopharmaceuticals R&D department. This scientific role works...
-
Regulatory Affairs Director
3 days ago
Gaithersburg, United States The Economic Development Alliance for Brazoria Co Full timeRegulatory Affairs Director - Oncology Cell and Gene Therapy Regulatory Affairs Director - Oncology Cell and Gene Therapy AstraZeneca Pharmaceuticals LP Location: Gaithersburg, Maryland Type: Full-Time, Non-Remote Posted on: April 2, 2024 Apply at Original Source #J-18808-Ljbffr
-
Associate Director, Patient Safety Scientist
4 hours ago
Gaithersburg, United States AstraZeneca PLC Full timeAssociate Director, Patient Safety Scientist Location: Onsite 3 days in Gaithersburg This is an opportunity to further develop your pharmacovigilance (PV) experience in safety programmes, spanning the entire life cycle of drug development and peri-/post-submission. Our Scientists and Physicians play a strategic role in developing our medicines and the...
-
Associate Director
7 hours ago
Gaithersburg, United States AstraZeneca PLC Full timeAssociate Director (Human Factors Engineering) Do you have a passion for science? Would you like to apply your expertise to impact a company that follows the science and turns ideas into life changing medicines? Then AstraZeneca might be the place for you! At AstraZeneca, we put patients first and strive to meet their unmet needs worldwide. Working here...
-
Associate Director
2 days ago
Gaithersburg, United States AstraZeneca Full time**Associate Director (Integrated Bioanalysis)** **Bold Disruptors. Push the boundaries of science. Fearlessly break new ground.** Are you ready to work at the cutting-edge, where scientific innovations and an entrepreneurial spirit are the norm? We’re looking for dynamic thought leaders with curious minds, who are comfortable taking smart risks and...
-
Associate Director Study Leader Cell Therapy
6 days ago
Gaithersburg, United States Workday Full timeAre you ready to take our leading Oncology pipeline to the next level? As an Associate Director (AD) Study Leader Cell Therapy, you will be responsible for delivering a single or several smaller Cell Therapy development programs. This role requires a high degree of flexibility and autonomy, as you may also provide expert input to other non-drug programs and...
-
Associate Director Study Leader Cell Therapy
1 week ago
Gaithersburg, United States CareerBuilder Full timeAre you ready to take our leading Oncology pipeline to the next level? As an Associate Director (AD) Study Leader Cell Therapy, you will be responsible for delivering a single or several smaller Cell Therapy development programs. This role requires a high degree of flexibility and autonomy, as you may also provide expert input to other non-drug programs and...
-
Gaithersburg, United States Taleo BE Full timeAssociate Director- Flow Cytometry Specialist- Integrated BioanalysisGaithersburg, USBold Disruptors. Push the boundaries of science. Fearlessly break new ground.Are you ready to work at the cutting-edge, where scientific innovations and an entrepreneurial spirit are the norm? Were looking for dynamic thought leaders with curious minds, who are comfortable...
-
Gaithersburg, United States Taleo BE Full timeAssociate Director- Flow Cytometry Specialist- Integrated Bioanalysis Gaithersburg, US Bold Disruptors. Push the boundaries of science. Fearlessly break new ground. Are you ready to work at the cutting-edge, where scientific innovations and an entrepreneurial spirit are the norm? We’re looking for dynamic thought leaders with curious minds, who are...
-
Associate Director, Flow Cytometry Specialist
23 hours ago
Gaithersburg, United States AstraZeneca Full timeAssociate Director- Flow Cytometry Specialist- Integrated Bioanalysis Gaithersburg, US Bold Disruptors. Push the boundaries of science. Fearlessly break new ground. Are you ready to work at the cutting-edge, where scientific innovations and an entrepreneurial spirit are the norm? Were looking for dynamic thought leaders with curious minds, who are...
-
Director, Safety and Mechanistic Pharmacology
4 hours ago
Gaithersburg, United States AstraZeneca PLC Full timeAre you an expert within Safety Pharmacology with extensive knowledge in designing and interpreting high quality studies, translating scientific findings into applicable information in a drug development environment? Be part of a dedicated Research & Development team. Fuelled by our commitment to help more patients, strengthen our pipeline and grow our...
-
Associate Director- Molecular Specialist
7 hours ago
Gaithersburg, United States AstraZeneca PLC Full timeBold Disruptors. Push the boundaries of science. Fearlessly break new ground. Are you ready to work at the cutting-edge, where scientific innovations and an entrepreneurial spirit are the norm? We're looking for dynamic thought leaders with curious minds, who are comfortable taking smart risks and constantly challenging the boundaries of science all the...
-
Senior Director Clinical Programs
Found in: Appcast US C2 - 2 weeks ago
Gaithersburg, United States Zenith LifeScience Full timePreferred work locations are Gaithersburg, Maryland or Wilmington, Delaware (Hybrid)Provides expert clinical operational input into project or study level documents, for example clinical development plan, clinical study protocol, clinical study report, and may lead the delivery of study documentsWith oversight from the Senior Director Clinical Programs, may...
-
Senior Director Clinical Programs
Found in: Appcast Linkedin GBL C2 - 2 weeks ago
Gaithersburg, United States Zenith LifeScience Full timePreferred work locations are Gaithersburg, Maryland or Wilmington, Delaware (Hybrid)Provides expert clinical operational input into project or study level documents, for example clinical development plan, clinical study protocol, clinical study report, and may lead the delivery of study documentsWith oversight from the Senior Director Clinical Programs, may...
-
Associate Installer
1 week ago
Gaithersburg, United States One Source Systems Full timeJob DescriptionJob Description**Position Overview: Associate Installer***The successful candidate for the Associate Installer position must possess a fundamental understanding of low voltage systems and exhibit a capacity to follow instructions diligently. Adaptability, a strong work ethic, punctuality, and the ability to drive a personal vehicle to job...
-
Staff Scientist
2 days ago
Gaithersburg, United States VRL Full timeJob DescriptionJob DescriptionOVERVIEW:This is an excellent opportunity for an experienced individual in immunodiagnostics and molecular diagnostics. The individual will be responsible for the development and implementation of diagnostic assays for the identification of research animal pathogens. He/she/they will make scientific observations, maintain...
-
Staff Scientist
1 week ago
Gaithersburg, United States VRL Full timeJob DescriptionJob DescriptionOVERVIEW:This is an excellent opportunity for an experienced individual in immunodiagnostics and molecular diagnostics. The individual will be responsible for the development and implementation of diagnostic assays for the identification of research animal pathogens. He/she/they will make scientific observations, maintain...