4 Regulatory Affairs Manager New Opportunity jobs in County Dublin

Position Overview We are seeking a highly motivated Regulatory Affairs CMC Specialist to join our Regulatory Affairs team at Helsinn Birex Pharmaceuticals Ltd, based in Dublin 15. In this role, you will support the management and maintenance of Marketing Authorisations (MAs) in compliance with European and international regulations. You will work closely with regulatory authorities, internal stakeholders, and external partners to ensure the smooth lifecycle management of our pharmaceutical products. Key Responsibilities Prepare and submit Marketing Authorisation Applications (MAAs), variations, renewals, and post-authorisation activities in line with European regulatory requirements. Manage communications and respond to queries from regulatory authorities (EMA, EU and non-EEA competent authorities). Publish dossiers and submissions using validated document management systems and ensure correct electronic formats. Ensure compliance between authorised Marketing Authorisations and manufacturing site procedures. Review and evaluate proposed changes related to quality, manufacturing, supply chain, and Contract Manufacturing Organisations (CMOs). Review and approve product artwork to ensure regulatory compliance. Liaise with Helsinns corporate office and licensing partners to support regulatory activities. Manage correspondence and compliance activities with the HPRA, including manufacturing and active substance registrations. Review GMP documentation (specifications, batch records, analytical methods) related to regulatory compliance. Maintain up-to-date regulatory status information and circulate regulatory approval notices internally. Contribute to continuous improvement initiatives within Regulatory Affairs. Adhere to company policies, cGMP, EHS, and quality standards. Required Qualifications and Experience Bachelors degree in Pharmacy, Chemistry, Life Sciences, or a related discipline. Minimum 5 years of experience in pharmaceutical regulatory affairs, with a focus on CMC (Chemistry, Manufacturing, and Controls) activities. Proven experience preparing and submitting Marketing Authorisation Applications and related documentation in the EU. Knowledge of EU pharmaceutical regulations, EMA guidelines, and experience liaising with regulatory authorities. Familiarity with GMP and quality systems in a pharmaceutical manufacturing environment. Experience using electronic document management and publishing systems. Strong attention to detail and organisational skills. Excellent written and verbal communication skills in English. Ability to work independently and collaboratively within a team. Key Competencies Regulatory Knowledge: Strong understanding of regulatory frameworks applicable to pharmaceutical products in the EU and internationally. Analytical Thinking: Ability to evaluate complex data and regulatory requirements effectively. Communication: Clear and professional communication with internal teams, regulatory authorities, and external partners. Project Management: Ability to manage multiple tasks and deadlines while maintaining high-quality standards. Problem Solving: Proactive in identifying issues and proposing compliant solutions. Teamwork: Collaborative approach to working with colleagues and cross-functional teams. Integrity & Ethics: Commitment to confidentiality, compliance, and ethical conduct. Adaptability: Flexible and responsive to changing regulatory requirements and business needs. Skills: Regulatory Affairs CMC Marketing Authorisation Applications Pharma GMP Pharmaceutical Regulations Benefits: Health Insurance Performance Bonus Pension Scheme Parking Space with EV Charger Flex Time Work from Home Scheme

At Regeneron, we're advancing science and medicine to improve lives. We're seeking a talented Regulatory Affairs Manager to join our team and play a pivotal role in supporting EU regulatory activities for oncology drug development. This is your chance to contribute to groundbreaking clinical development programs while collaborating with global experts and building relationships across the EU regulatory network. Join us in shaping the future of oncology treatments and making a meaningful impact on patients' lives. A Typical Day: As a Regulatory Affairs Manager, your day might include: Developing regulatory strategies for oncology programs by researching guidelines, EU precedents, and emerging trends. Managing CTA submissions via CTIS for multiple EU member states, ensuring compliance with EU requirements. Organizing, preparing, and reviewing CTA amendments, annual reports, and other regulatory documents. Performing critical analyses of clinical and preclinical data to develop interpretations and conclusions. Leading EU Scientific Advice requests and coordinating EMA and EU national agency meetings. Monitoring newly published EU Commission and EMA guidelines to ensure compliance and provide training for scientific staff. Representing Regeneron Regulatory Affairs in engagements with EMA scientific committees, EU national agencies, and industry associations. This Role May Be For You If: You are someone who: Thrives in a collaborative environment and enjoys working with multidisciplinary teams. Has a proven ability to navigate EU regulatory frameworks and requirements. Is detail-oriented and skilled in analyzing clinical and preclinical data. Has experience leading regulatory agency meetings and negotiating effectively with stakeholders. Is passionate about contributing to oncology drug development programs. Values continuous learning and stays updated on emerging regulatory trends. Has excellent written and verbal communication skills. To Be Considered: We're looking for candidates with: An advanced degree in a scientific discipline. At least 4 years of regulatory experience, with a focus on clinical development. Proven experience supporting EU Clinical Trial Applications through approval and study start-up. Familiarity with EMA processes such as scientific advice, orphan designation, and PIPs. Experience in oncology regulatory strategy is an advantage. A strong ability to negotiate and express clear positions to stakeholders at all levels. Preferred qualifications include experience with marketing authorization applications or life-cycle management of approved products in the centralized procedure. Why Join Us? At Regeneron, we believe in fostering innovation, collaboration, and growth. You'll have the opportunity to work with a passionate team dedicated to advancing science and improving patient outcomes. Together, we'll make a difference. Does this sound like you? Apply now to take your first step towards living the Regeneron Way. We have an inclusive and diverse culture that provides comprehensive benefits, which often include (depending on location) health and wellness programs, fitness centers, equity awards, annual bonuses, and paid time off for eligible employees at all levels. Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or parental status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations. The Company will also provide reasonable accommodation to the known disabilities or chronic illnesses of an otherwise qualified applicant for employment, unless the accommodation would impose undue hardship on the operation of the Company's business. For roles in which the hired candidate will be working in the U.S., the salary ranges provided are shown in accordance with U.S. law and apply to U. positions. For roles which will be based in Japan and/or Canada, the salary ranges are shown in accordance with the applicable local law and currency. If you are outside the U.S, Japan or Canada, please speak with your recruiter about salaries and benefits in your location. Please note that certain background checks will form part of the recruitment process. Background checks will be conducted in accordance with the law of the country where the position is based, including the type of background checks conducted. The purpose of carrying out such checks is for Regeneron to verify certain information regarding a candidate prior to the commencement of employment such as identity, right to work, educational qualifications etc.

At Gilead, we're creating a healthier world for all people. For more than 35 years, we've tackled diseases such as HIV, viral hepatitis, COVID-19 and cancer - working relentlessly to develop therapies that help improve lives and to ensure access to these therapies across the globe. We continue to fight against the world's biggest health challenges, and our mission requires collaboration, determination and a relentless drive to make a difference.
Every member of Gilead's team plays a critical role in the discovery and development of life-changing scientific innovations. Our employees are our greatest asset as we work to achieve our bold ambitions, and we're looking for the next wave of passionate and ambitious people ready to make a direct impact.
We believe every employee deserves a great leader. People Leaders are the cornerstone to the employee experience at Gilead and Kite. As a people leader now or in the future, you are the key driver in evolving our culture and creating an environment where every employee feels included, developed and empowered to fulfil their aspirations. Join Gilead and help create possible, together.
**Job Description**
Global Therapeutic Area (TA) Regulatory Liaisons is a core function within Gilead's Global Regulatory Affairs (GRA) organization and acts as a critical strategic partner across drug discovery, development and commercial teams. Global TA Regulatory Liaisons develop regulatory strategic options and work closely with cross-functional leaders and regulatory authorities to determine appropriate pathways to obtain and maintain licensure and optimal formulary listings. These strategies are essential in obtaining and maintaining licensure of Gilead's medicinal products and proprietary methodologies and technologies by managing registrations, other filings and regulatory agency communications and interactions in our key markets around the world.
Gilead's Pediatric Center of Excellence is a global hub in Dublin, Ireland, dedicated to advancing research and development of treatments for children with serious diseases, including HIV, viral hepatitis, COVID-19, and cancer. You will act as the Franchise Lead for Regulatory Affairs at the Pediatric Center of Excellence. You will provide leadership and mentorship for your direct reports by overseeing and guiding the development and execution of regulatory strategies, plans and objectives for pediatric development of products and compounds across the Virology, Oncology and Inflammation therapeutic areas in alignment with and within the overall global development of a product. This may include overseeing the development of global pediatric regulatory plans and preparation of pediatric regulatory submissions, monitoring the progress and completion of global pediatric commitments, and guiding and advising colleagues in the thorough and compliant completion of these activities. You may act as the Global Regulatory Lead and/or the serve as a Gilead contact to / for regulatory authorities as needed.
As **Senior Director, Global Regulatory Affairs Liaison - Pediatric Center of Excellence** , you will act as a senior regulatory representative and pediatric subject matter expert to cross-functional leaders and teams. You will play a leadership role on regulatory leadership teams, at the Pediatric Center of Excellence and in ad hoc or special projects/initiatives that seek to continuously improve or advance GRA capabilities.
**RESPONSIBILITIES:**
+ Accountable for oversight and leadership of the development and successful completion of global pediatric regulatory strategies, submissions, documents, activities, and other deliverables for products across the Virology, Oncology and Inflammation TAs to achieve strategic milestones and objectives.
+ Makes significant contributions to the ongoing development and optimization of pediatric regulatory strategies, processes, standards, and practices in collaboration across Global TA regulatory liaisons and cross-functional teams to ensure alignment with broader product development goals, driving efficiency and enhancing organizational capabilities.
+ Represents Gilead in negotiations with regulatory authorities as needed.
+ Proactively identifies regulatory or pediatric-related risks/issues and ensures timely development of mitigation and/or contingency plans.
+ Manages one or more direct reports.
+ Provides accurate and thorough input and recommendations into resource plans required to complete deliverables. Tracks resources to ensure compliance with agreed resource allocation, including budgets.
+ Ensures own work complies with established practices, policies and processes, and any regulatory or other requirements.
+ Provides significant leadership as a member of the Global TA Regulatory Liaison leadership team and leads or contributes to non-program-related corporate/department initiatives, process improvements, best practices, and projects.
+ Provides leadership and advisement for Pediatric Center of Excellence site management.
**REQUIREMENTS:**
We are all different, yet we all use our unique contributions to serve patients.
Please see the following for the qualifications and skills we seek for this role:
**Education & Experience**
+ MA/MS/MBA/PharmD/PhD with 12+ years' relevant experience.
+ BA/BS with 14+ years' relevant experience.
+ Extensive experience in Global Regulatory Affairs (pharmaceutical industry experience is strongly preferred) and developing global pediatric regulatory strategies.
+ Experience working with one or more Gilead therapeutic areas and varying stages of drug development is strongly preferred.
+ Extensive leadership experience and proven effectiveness through direct people leadership or matrix leadership.
+ Extensive experience and significant successes setting and directing the regulatory or related strategy to successful conclusion for multiple products.
+ Experience and proven effectiveness negotiating with regulatory authorities.
+ Extensive experience leading and influencing cross-functional teams and activities across a broad spectrum of programs, projects and other activities.
+ Proven track record of successfully managing large scale, complex, time-sensitive projects.
**Knowledge & Skills**
+ Exceptional interpersonal, self-awareness and negotiation skills, including effective verbal/written communication, team orientation, critical thinking, active listening, problem-solving, dependability, and adaptability, and understanding of team dynamics.
+ Expert knowledge of the drug development process, and global and regional regulatory requirements for medicinal products.
+ Advanced regulatory and business knowledge and advanced analytical abilities, as evidenced by strengths in assessing complex, multidisciplinary data, and understanding and effectively advising on its regulatory implications.
+ Demonstrable ability to effectively communicate project direction and status to varying organizational levels, including leadership teams, executives and steering committees.
+ Ability to summarize complex matters into a clear business case and roadmap for execution.
+ Strong coaching capabilities to mentor/develop staff.
+ When needed, ability to travel.
+ **This role requires the successful candidate to work at our Dublin office - therefore candidates that are not based within a commutable distance to the office must be open to relocation.**
**Equal Employment Opportunity (EEO)**
It is the policy of Gilead Sciences, Inc. and its subsidiaries and affiliates (collectively "Gilead" or the "Company") to recruit select and employ the most qualified persons available for positions throughout the Company. Except if otherwise provided by applicable law, all employment actions relating to issues such as compensation, benefits, transfers, layoffs, returns from layoffs, company-sponsored training, education assistance, social and recreational programs are administered on a non-discriminatory basis (i.e. without regard to protected characteristics or prohibited grounds, which may include an individual's gender, race, color, national origin, ancestry, religion, creed, physical or mental disability, marital status, sexual orientation, medical condition, veteran status, and age, unless such protection is prohibited by federal, state, municipal, provincial, local or other applicable laws). Gilead also prohibits discrimination based on any other characteristics protected by applicable laws.
**For Current Gilead Employees and Contractors:**
Please apply via the Internal Career Opportunities portal in Workday.
Gilead Sciences, Inc. is a biopharmaceutical company that has pursued and achieved breakthroughs in medicine for more than three decades, with the goal of creating a healthier world for all people. The company is committed to advancing innovative medicines to prevent and treat life-threatening diseases, including HIV, viral hepatitis and cancer. Gilead operates in more than 35 countries worldwide, with headquarters in Foster City, California.