All active Regulatory Affairs roles based in Ireland.
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viagogo is the world’s leading marketplace to buy and sell tickets to any live event, anywhere. Through viagogo internationally and StubHub, our platform in North America, we service customers in 195 countries in 33 languages and 49 available currencies. With more than 300 million tickets available to events around the world annually -- from sports to music, comedy to dance, festivals to theater -- viagogo offers the safest, most convenient way to buy or sell tickets to the most memorable live experiences.
Viagogo is on a mission to redefine the live event experience on a global scale. Whether someone is looking to attend their first event or their hundredth, we’re here to delight them all the way from the moment they start looking for a ticket until they step through the gate. The same goes for our sellers. From fans selling a single ticket to the promoters of a worldwide stadium tour, we want viagogo to be the safest, most convenient way to offer a ticket to the millions of fans who browse our platform around the world.
Job Description:
The International Government Affairs team is seeking a Policy and Public Affairs Analyst to support the company’s government relations and regulatory engagement function across markets worldwide. This is a global-scope role based in Limerick, Ireland, reporting directly to the Head of International Government Affairs.
The team operates at the intersection of competition law, consumer policy and digital markets regulation across the EU, UK, Latin America and Asia-Pacific. The Policy Analyst will provide the research, monitoring and drafting infrastructure that allows the government affairs team to focus on direct engagement with legislators, regulators and competition authorities. This is not a junior administrative role: the successful candidate will produce outputs used directly in parliamentary submissions, regulatory filings and briefings to government officials.
Key Responsibilities:
Position Type and Expected Hours of Work:
Qualifications and experience:
Desirable:
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Olema Oncology is dedicated to developing better medicines for breast cancer and beyond. Our lead program, palazestrant (OP-1250), is a complete estrogen receptor antagonist (CERAN) currently in development for metastatic breast cancer with blockbuster potential as a monotherapy and in combination in ER+/HER2- metastatic breast cancer. Our follow-on product candidate, OP-3136, is a potent KAT6 inhibitor with best-in-class potential.
Our scientific breakthroughs are accelerated through the ways in which we fearlessly support, motivate, and challenge one another. At Olema, we know that when we put people first, our work becomes second to none. If you’re ready to join us at the edge of something unstoppable, let’s make a profound impact together for our patients, for your career, for what’s beyond.
You can view our latest corporate deck and other presentations here.
About the Role >>> Sr Director, Commercial Manufacturing & Operations
As the Sr Director, Commercial Manufacturing & Operations reporting to the SVP of CMC & Supply Chain, you will be an experienced manager with a track record of successful project leadership and oversight of late-stage (registrational, process validation, commercial) manufacturing of small molecule drug substances and drug products. You will be responsible for the execution of technical transfer (including process validation activities), oversight of manufacturing activities, document review, quality event support, etc. for drug substances and drug product.
This role is based out of our Boston, USA and will require 20% travel.
Your work will primarily encompass:
· Support the US launch of palazestrant in 2027 by creating the commercial supply platform and strategy
· Establish an operational commercial mapping of supply and partners (state licenses, 3PL & order-to-cash Services, shipping and import/export logistics, import/export compliance)
· Provide technical and functional project leadership on drug substance (DS) and drug product (DP) commercial manufacturing, and CMO management
· Develop business processes and systems to support and streamline all DS and DP commercial activities. Work globally to implement processes and systems within Olema’s global CDMO network. Develop metrics and continuous improvement initiatives.
· Ensure employees are engaged and tied to the global Olema’s business strategy
· Lead or manage documentation review and approval (MBRs, specifications, analytical methods, etc.), change controls and documentation for internal batch disposition
· Oversee investigations related to deviations to assess impact to product and manufacturing process; ensures timely closure of such investigations
· Partner with Commercial, Quality Assurance and CMC Regulatory Affairs SMEs to develop and operate appropriate commercial procedures to ensure the drug substance and drug product meets established quality standards and adheres to established and regulatory agency approved parameters
· Work closely with SMEs and CMOs to execute shipment of drug substance batches and drug product lots
· Partner with supply chain teams to design DS and DP production schedules while maximizing production and cost efficiencies
· Develop, maintain and communicate product manufacturing plans, timelines, milestones and budgets. Integrate and align commercial manufacturing activities with corporate development program objectives. Develop and apply resource and capacity models
· Stay current with state-of-the art approaches and applicable global regulations and industry standards
Ideal Candidate Profile >>>
A love of challenging, important work. We are a pragmatic team, driven to imagine and develop meaningful therapies for improving lives. All employees within our company play a unique and crucial role in our success, both in accomplishing our mission and building a positive company culture. As such, we are looking for someone with the right combination of knowledge, experience, and attributes for this role.
Knowledge and experience:
· BS/MS/Ph.D. in Chemistry, or related discipline with a minimum of 10+ years of experience, or a business degree with a minimum of 15 years of experience, in a CMC development and manufacturing organization
· Sense of urgency, ability to recognize time sensitivity, appetite to lead aggressive activity within the manufacturing function
· Flexible and adaptable style, achievement oriented by nature with a willingness and eagerness to take on challenges
· Visionary as well as tactile and concrete at an operational level.
· Demonstrated successful leadership in a pharmaceutical CMC drug substance and drug product development and manufacturing role
· Broad experience working with CDMOs and managing external development and manufacturing partners
· Expertise in oversight of GMP manufacturing, including tech transfer and process validation
· Understanding of supplier performance management (quality metrics, adherence to supply and quality agreements) and familiarity with commercial supply agreement negotiations
· Thorough understanding of global regulatory requirements for the manufacture, testing, and control of commercial drug substances
· Strong communication, negotiation, problem solving and decision-making skills at all levels of the organization, verbally and in writing
· Ability to work collaboratively to connect vision, strategy and goals and present plans, justifications and mitigation scenarios to executive management
· Effective written, oral communication and interpersonal skills
Attributes:
· A high level of curiosity, intelligence, ability to work independently, “can do” attitude, and ability to work cross-functionally. Strong initiative and follow-through are essential for this job.
· Specific personal characteristics include:
o Highly analytical and detail oriented
o Self-Starter
o Goal and data driven
o Ability to multi-task and shift priorities rapidly to meet tight deadlines
o Aspires to the highest scientific and ethical standards
o Keen to improve processes and overcome inefficiencies
The base pay range for this position is expected to be $225,000 - $250,000 annually, however the base pay offered may vary depending on location, market, job related knowledge, skills and capabilities, and experience. The total compensation package for this position also includes equity, bonus, and benefits.
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Important Information >>>
We provide equal opportunity to all employees and applicants for employment and believe that great ideas and discoveries come from a mix of expertise, background, and experience. Olema is building a culture where the value of difference is celebrated.
We offer a competitive compensation and benefits package, seeking to provide an open, flexible, and friendly work environment to empower employees and provide them with a platform to develop their long-term careers. A Summary of Benefits is available for all applicants.
Please note: Olema doesn’t accept agency resumes and is not responsible for any fees related to unsolicited resumes. Thank you.
Fraud Alert: We are aware of employment scams where individuals pose as representatives of Olema Oncology and make false use of our company name to defraud job seekers. To protect yourself, please note that Olema’s official email addresses end in @olema.com. Our official corporate website is olema.com; our careers page is olema.com/careers; our LinkedIn page is linkedin.com/company/olema-oncology. Please visit these links for official information from Olema. Communication from any other variant is fraudulent. Olema does not conduct interviews via text message/messaging platforms, will not ask you to download anything as part of your interview, will never request any form of payment, provide upfront payments of any kind, and does not make job offers without an in-person interview.
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Cytokinetics is a late-stage, specialty cardiovascular biopharmaceutical company focused on discovering, developing and commercializing first-in-class muscle activators and next-in-class muscle inhibitors as potential treatments for debilitating diseases in which cardiac muscle performance is compromised. As a leader in muscle biology and the mechanics of muscle performance, the company is developing small molecule drug candidates specifically engineered to impact myocardial muscle function and contractility.
Job purpose
As the Associate Director, External Manufacturing and Supply Operations, you are responsible for operational execution of external manufacturing and related supply activities. This is a central role within Manufacturing and External Supply Operations and requires the ability to manage multiple activities simultaneously, balancing priorities, with a strong sense of urgency, ability to work with ambiguity, and attention to detail. This position will have you collaborating with other members of Supply Chain, Quality Assurance, Regulatory Affairs, and Finance to execute and deliver endorsed global supply plans for both clinical and commercial supply. You will report to the Director, External Supply Operations.
Responsibilities
Qualifications
Education & Core Experience
Our employees come from different backgrounds, and we celebrate those differences. We are looking for the best candidates for our open roles, but do not expect applicants to meet every qualification in order to be considered. If you are excited about what you could accomplish at Cytokinetics and believe you can add value to our team, we would love to hear from you.
Please review our General Data Protection Regulation (GDPR) policy PRIOR to applying.
Our passion is anchored in robust scientific thinking, grounded in integrity and critical thinking. We keep the patient front and center in all we do – all actions and decisions are in service of the patient and their caregivers. We champion integrity, ethics, doing the right thing, and being our best selves.
Fraud Warning: How to Identify Impersonated Cytokinetics Job Postings and Offers
Recently, there have been fraudulent employment offers being sent to candidates on behalf of Cytokinetics. Please be advised that all legitimate offers from Cytokinetics will come directly from our official email domain (Cytokinetics.com) and will only be made after completing a formal interview process.
Here are some ways to check for authenticity:
Please visit our website at: www.cytokinetics.com
Cytokinetics is an Equal Opportunity Employer
Ready to apply?
Apply to Cytokinetics
Share this job
Cytokinetics is a late-stage, specialty cardiovascular biopharmaceutical company focused on discovering, developing and commercializing first-in-class muscle activators and next-in-class muscle inhibitors as potential treatments for debilitating diseases in which cardiac muscle performance is compromised. As a leader in muscle biology and the mechanics of muscle performance, the company is developing small molecule drug candidates specifically engineered to impact myocardial muscle function and contractility.
Job purpose
As a Manager, External Manufacturing and Supply Operations, you are responsible for the end-to-end technical and operational oversight of external manufacturing and supply activities across a network of Contract Manufacturing Organizations (CMOs). This role sits at the core of Manufacturing and External Supply Operations and requires a strong technical foundation, the ability to manage multiple concurrent priorities, and to operate effectively in a fast-paced, ambiguous environment.
This position places particular emphasis on batch record review and approval, process oversight, and technical decision-making, ensuring that manufacturing activities are executed in full compliance with cGMP standards and aligned with global supply requirements.
You will collaborate cross-functionally with Quality Assurance, Technical Operations, Regulatory Affairs, and Supply Chain to ensure robust, compliant, and reliable supply for both clinical and commercial products. You will report to the Director, External Supply Operations.
Responsibilities
Qualifications
Education & Core Experience
Our employees come from different backgrounds, and we celebrate those differences. We are looking for the best candidates for our open roles, but do not expect applicants to meet every qualification in order to be considered. If you are excited about what you could accomplish at Cytokinetics and believe you can add value to our team, we would love to hear from you.
Please review our General Data Protection Regulation (GDPR) policy PRIOR to applying.
Our passion is anchored in robust scientific thinking, grounded in integrity and critical thinking. We keep the patient front and center in all we do – all actions and decisions are in service of the patient and their caregivers. We champion integrity, ethics, doing the right thing, and being our best selves.
Fraud Warning: How to Identify Impersonated Cytokinetics Job Postings and Offers
Recently, there have been fraudulent employment offers being sent to candidates on behalf of Cytokinetics. Please be advised that all legitimate offers from Cytokinetics will come directly from our official email domain (Cytokinetics.com) and will only be made after completing a formal interview process.
Here are some ways to check for authenticity:
Please visit our website at: www.cytokinetics.com
Cytokinetics is an Equal Opportunity Employer
Ready to apply?
Apply to Cytokinetics
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