global regulatory affairs associate director (cardio-metabolic) Jobs in London United Kingdom

global regulatory affairs associate director (cardio-metabolic)

associate director - cmc regulatory affairs Jobs in London United Kingdom

associate director - cmc regulatory affairs

associate, healthcare consulting Jobs in London United Kingdom

associate, healthcare consulting

global head of marketing Jobs in London United Kingdom

global head of marketing

senior compliance analyst Jobs in London United Kingdom

senior compliance analyst

global regulatory affairs associate director cardio metabolic

Novartis Farmacéutica

Choose LocationChoose Location# Global Regulatory Affairs Associate Director (Cardio-Metabolic)REQ-Oct 14, 2025United Kingdom Summary (12 days per month on-site) Location: London (The Westworks), United Kingdom or Dublin, Ireland Internal Job Title: Global Program Regulatory Associate Director We are looking for an experienced and proactive Senior Global Program Regulatory Manager to join our Global Regulatory Affairs team.The role involves directing the development and submission of regulatory documents, providing strategic direction and negotiating with agencies to expedite approvals. It also ensures timely approval and compliance of new and marketed products, and serves as a regulatory liaison throughout the product lifecycle. About the Role Major accountabilities: Lead the implementation of regulatory strategies and operational activities across major global regions. Provide strategic input into global regulatory plans, identifying risks and contributing to key planning documents. Align regional regulatory approaches with global objectives through collaboration with cross-functional and regional teams. Define and manage Health Authority (HA) interaction strategies, including preparation of briefing materials. Oversee the planning, coordination, and submission of regulatory dossiers (e.g., CTAs, INDs, Risk Management Plans). Serve as a liaison with local HAs (e.g., FDA, EMA) and lead or support negotiations for regional approvals. Develop and implement strategies to minimize review delays and regulatory clock stops. Ensure timely and compliant responses to HA queries and requests. Contribute to departmental goal setting and lead initiatives to improve regulatory processes. Ensure adherence to internal policies, SOPs, and global regulatory requirements. Minimum requirements: Bachelor's or Master's degree in Life Sciences, Pharmacy, or a related field. Significant experience in regulatory affairs within the pharmaceutical industry. Proven track record in project management and regulatory operations. Experience representing the organization in cross-functional and cross-cultural settings. Strong knowledge of clinical trials, drug development, and regulatory compliance. Excellent problem-solving, negotiation, and communication skills. Detail-oriented with the ability to manage complex regulatory projects. Skilled in risk management and working with cross-functional teams. Ability to navigate and influence Health Authority interactions. Fluency in English (written and spoken) is essential. Commitment to Diversity and Inclusion/EEO Novartis is committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve. Why Novartis: Join our Novartis Network: Benefits and Rewards: Read our handbook to learn about all the ways we'll help you thrive personally and professionally:DevelopmentUniversal Hierarchy NodeUnited KingdomLondon (The Westworks)GB16 (FCRS = GB016) Novartis Pharmaceuticals UK Ltd.Research & DevelopmentFull timeRegularNoNovartis is committed to building an outstanding, inclusive work environment and diverse teams' representative of the patients and communities we serve.REQ- Global Regulatory Affairs Associate Director (Cardio-Metabolic)<img src="https://www.jobg8.com/Tracking.aspx?n70Gs5vBCd8IWwUuLMXZlaNb9isvX8%2f5f" width="0" height="0" />

Global Regulatory Affairs Associate Director (Cardio-Metabolic)

Healthcare Businesswomens Association

Job Description Summary (12 days per month on-site) Location: London (The Westworks), United Kingdom or Dublin, Ireland Internal Job Title: Global Program Regulatory Associate Director Job Description We are looking for an experienced and proactive Senior Global Program Regulatory Manager to join our Global Regulatory Affairs team. The role involves directing the development and submission of regulatory documents, providing strategic direction and negotiating with agencies to expedite approvals. It also ensures timely approval and compliance of new and marketed products, and serves as a regulatory liaison throughout the product lifecycle. Major Accountabilities <ul> <li>Lead the implementation of regulatory strategies and operational activities across major global regions.</li> <li>Provide strategic input into global regulatory plans, identifying risks and contributing to key planning documents.</li> <li>Align regional regulatory approaches with global objectives through collaboration with cross-functional and regional teams.</li> <li>Define and manage Health Authority (HA) interaction strategies, including preparation of briefing materials.</li> <li>Oversee the planning, coordination, and submission of regulatory dossiers (e.g., CTAs, INDs, Risk Management Plans).</li> <li>Serve as a liaison with local HAs (e.g., FDA, EMA) and lead or support negotiations for regional approvals.</li> <li>Develop and implement strategies to minimize review delays and regulatory clock stops.</li> <li>Ensure timely and compliant responses to HA queries and requests.</li> <li>Contribute to departmental goal setting and lead initiatives to improve regulatory processes.</li> <li>Ensure adherence to internal policies, SOPs, and global regulatory requirements.</li> </ul> Minimum Requirements <ul> <li>Bachelor's or Master's degree in Life Sciences, Pharmacy, or a related field.</li> <li>Significant experience in regulatory affairs within the pharmaceutical industry.</li> <li>Proven track record in project management and regulatory operations.</li> <li>Experience representing the organization in cross-functional and cross-cultural settings.</li> <li>Strong knowledge of clinical trials, drug development, and regulatory compliance.</li> <li>Excellent problem-solving, negotiation, and communication skills.</li> <li>Detail-oriented with the ability to manage complex regulatory projects.</li> <li>Skilled in risk management and working with cross-functional teams.</li> <li>Ability to navigate and influence Health Authority interactions.</li> <li>Fluency in English (written and spoken) is essential.</li> </ul> Commitment to Diversity and Inclusion/EEO Novartis is committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve. Skills Desired <ul> <li>Clinical Trials</li> <li>Cross-Functional Teams</li> <li>Detail-Oriented</li> <li>Drug Development</li> <li>Lifesciences</li> <li>Negotiation SkillsProblem Solving SkillsRegulatory ComplianceRisk Management</li> </ul><img src="https://www.jobg8.com/Tracking.aspx?vAeLusD9WE0pILu4uWEJNiiMBr948H6fb" width="0" height="0" />

Medpace, Inc.

Job Summary We are seeking several Medical Director to join our dynamic team. The Medical Director will have overall responsibility for providing medical, scientific, and strategic leadership for the successful planning, execution, and reporting of clinical trials. Additionally, this role acts as the Medpace internal medical expert and will serve as a medical resource for the review, presentation, and interpretation of results in the Clinical Study Report. The Medical Director will also be involved in the development of new clinical projects, including study design, protocol, and project plans as required.We are currently seeking Medical Directors in the following Therapeutic Areas:<ul><li>Neurology / CNS</li><li>Oncology (adult)</li><li>Cardiology (adult)</li><li>Gastroenterology</li><li>Metabolic / Endocrinology</li><li>Radiology</li><li>Infectious Disease</li><li>Immunology</li><li>Nephrology</li><li>Psychiatrist</li></ul>We are open to various locations throughout Europe. All Medical Directors have hybrid WFH flexibility. This role also has the ability to be fully remote with the right experience. Responsibilities <ul><li>Provide medical management and expertise for clinical trials;</li><li>Contribute medical expertise to study reports, regulatory documents, and manuscripts;</li><li>Manage safety issues in clinical trials and work closely with associates in evaluation and assessment of the trials;</li><li>Participate in new business development through involvement in proposal and sponsor meetings as requested;</li><li>Coordinate with other departments in all phases of the studies and trials including feasibility assessments, design processes, educational efforts, management of medical information, and reviewing and editing of medical documents;</li><li>Follow specific research related protocol and lead others in strict adherence to the policies.</li></ul> Qualifications <ul><li>Must have an M.D. with board certification and current medical licensure;</li><li>Must have prior clinical trial research experience; and</li><li>Previous experience in pharmaceutical-related clinical research is preferred.</li></ul>Travel: up to 20% Medpace Overview Medpace is a full-service clinical contract research organization (CRO). We provide Phase I-IV clinical development services to the biotechnology, pharmaceutical and medical device industries. Our mission is to accelerate the global development of safe and effective medical therapeutics through its scientific and disciplined approach. We leverage local regulatory and therapeutic expertise across all major areas including oncology, cardiology, metabolic disease, endocrinology, central nervous system, anti-viral and anti-infective. Headquartered in Cincinnati, Ohio, employing more than 5,000 people across 40+ countries. Why Medpace? People. Purpose. Passion. Make a Difference Tomorrow. Join Us Today.The work we've done over the past 30+ years has positively impacted the lives of countless patients and families who face hundreds of diseases across all key therapeutic areas. The work we do today will improve the lives of people living with illness and disease in the future.Medpace Perks<ul><li>Flexible work environment</li><li>Competitive compensation and benefits package</li><li>Competitive PTO packages</li><li>Structured career paths with opportunities for professional growth</li><li>Company-sponsored employee appreciation events</li><li>Employee health and wellness initiatives</li></ul>Awards<ul><li>Recognized by Forbes as one of America's Most Successful Midsize Companies in 2021, 2022, 2023 and 2024</li><li>Continually recognized with CRO Leadership Awards from Life Science Leader magazine based on expertise, quality, capabilities, reliability, and compatibility</li></ul>What to Expect NextA Medpace team member will review your qualifications and, if interested, you will be contacted with details for next steps.<img src="https://www.jobg8.com/Tracking.aspx?tmjKrTVbLoprzb9nV8nGLqknbbR%2fB8t8r" width="0" height="0" />

Therapeutic Area Medical Director

Perrigouk

Select how often (in days) to receive an alert: Associate Director - CMC Regulatory Affairs Location: London, GB, SW11 7BW; Dublin, IE, D02 TY74; Rotterdam, NL, 3062 CE; Ghent, BE, 9050; Chatillon, FR, 92320; Chatillon Cedex, FR, 92320At Perrigo, we are driven by our mission to Makes Lives Better Through Trusted Health and Wellness Solutions, Accessible to All. We are proud to be a Top 10 player in the European Consumer Self-Care market and the largest U.S. store brand provider of over the counter and infant formula. Dedicated to providing The Best Self-Care for Everyone, we are the people behind the brands you trust. We are Opill , Compeed , Solpadeine , NiQuitin , and many more. We Are Perrigo. We are committed to enhancing the wellbeing of our colleagues and consumers alike. We pride ourselves on fostering an inclusive, collaborative culture where each person can experience a sense of belonging.Join us on our One Perrigo journey as we evolve to win in self-care. Description Overview As Associate Director, you will lead the development and execution of cutting-edge Chemistry, Manufacturing & Control (CMC) strategies, ensuring the highest standards of regulatory excellence across our diverse portfolio-from pharmaceuticals and medical devices to supplements, cosmetics, and beyond.You will contribute to the creation of robust quality dossiers and the seamless navigation and influencing of regulatory landscapes, turning challenges into opportunities for innovation and growth. By delivering timely submissions and proactively identifying risks and mitigation plans, you'll enable first-to-market approvals that enhance Perrigo's reputation as a global leader in CMC.You will inspire and empower a high-performing regulatory team, instilling a culture of agility, compliance, and continuous improvement. Scope of the Role <ul><li>Lead global CMC regulatory strategy and execution for innovation projects, post-approval changes, lifecycle management, and compliance across all product categories.</li><li>Oversee the preparation, review, and submission of high-quality CMC documentation (e.g., Module 3, Quality Overall Summary) for global health authority submissions, including new MAAs/NDAs/ANDAs, variations, renewals, and compliance updates.</li><li>Develop and implement response strategies for regulatory queries and deficiency letters related to CMC matters. Engage in technical discussions with Competent Authorities in partnership with Country Regulatory teams.</li><li>Collaborate with cross-functional teams to ensure regulatory CMC alignment with commercial strategy, manufacturing changes, and global supply continuity.</li><li>Manage CMC strategy and documentation for complex CMC projects, such as tech transfers, major reformulations and geo-expansion</li><li>Manage CMC risks associated with ingredient challenges and develop action plans to support defence, in partnership with Regulatory Product Stewardship team.</li><li>Monitor global CMC regulatory trends and new regulations and guidance. Provide product impact assessments and strategic guidance to ensure continued compliance and readiness for evolving requirements, in partnership with Regulatory Product Stewardship team.</li><li>Represent Perrigo in external regulatory forums and trade associations to advocate for CMC-related policy positions and regulatory best practices.</li><li>Build and lead a high-performing, globally distributed team with deep expertise in CMC</li><li>Foster a culture of excellence, agility, innovation, and continuous learning.</li><li>Develop talent pipelines and succession plans to ensure long-term organizational capability.</li></ul> Experience Required <ul><li>Advanced degree in Life Sciences (PhD, PharmD, MSc preferred).</li><li>15+ years of progressive experience including management roles in CMC</li><li>Proven track record of successful global submissions and approvals across diverse product categories.</li><li>Strong strategic, financial, and operational acumen.</li><li>Exceptional leadership, collaboration, and stakeholder engagement skills.</li><li>Experience with global regulatory systems and digital platforms.</li></ul> Benefits We believe our people are our greatest asset. Alongside competitive compensation, we offer benefits tailored to supporting you and your family, as well as career development opportunities to ensure you feel valued and supported, both professionally and personally.Hybrid Working Approach We love our offices and the setting they provide for in-person collaboration and celebration. We also appreciate the opportunity to work remotely can energise you too, so we promote flexibility with the ability to work two days a week from home in many roles.We are proud to be included in the Forbes list of "America's Best Employers by State 2024". Find out more hereApplicants please note: To apply to this position please click the APPLY button at the bottom of the application. (The SAVE button will only save your profile information but not submit an application for this open position.) Thank you.We are an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, status as a protected veteran, or other characteristics protected by law. <img src="https://www.jobg8.com/Tracking.aspx?HuNA3DPAJ8sb3AkohtyD6%2b1Ih9%2bnDZPTm" width="0" height="0" />

Associate Director - CMC Regulatory Affairs

Barrington James Limited

I'm currently partnering with an innovative biotech company advancing a novel immunology pipeline and preparing for their first-in-human clinical study. This is a unique opportunity to join at a pivotal stage and shape the clinical and scientific strategy from the ground up.Key Responsibilities:<ul><li>Provide strategic clinical leadership as the company progresses from preclinical into FIH studies.</li><li>Oversee the design, execution, and medical oversight of early-phase clinical trials.</li><li>Lead interactions with global regulatory authorities to support IND and trial initiation.</li><li>Build and guide a high-performing clinical and medical affairs function.</li><li>Partner with executive leadership, board members, and investors to drive long-term development strategy.</li></ul>Ideal Profile:<ul><li>MD (board-certified in immunology is strongly preferred).</li><li>Significant clinical development experience, with a proven track record in early-phase and FIH trials.</li><li>Deep scientific expertise in immunology and immune-mediated diseases.</li><li>Entrepreneurial mindset with the ability to thrive in a lean, fast-paced biotech environment.</li><li>Previous CMO or senior clinical leadership experience in biotech or pharma.</li></ul><img src="https://www.jobg8.com/Tracking.aspx?CY95c1eotcyg1FqGBiopGnG0iTh3CxGCd" width="0" height="0" />

Chief Medical Officer

Mason Blake

Investment Solutions & Asset Allocation (Discretionary Wealth Management)- Associate Director Job details LocationLondonDate Posted6 September 2018CategoryInvestmentJob TypePermanentJob IDJ16766 Description An exciting opportunity to join a global Asset Manager who are looking to build out their digital wealth platform.This role will form part of a small, growing team set up to launch this new proposition and will help deliver, evolve and manage the discretionary investment offering.Key responsibilities include:<ul><li>Define the strategic asset allocation that are recommended to client and the ongoing tactical asset allocation</li><li>Select underlying vehicles used to express the asset allocation</li><li>Actively manage the funds within the asset allocation</li><li>Assist in the strategic assessment and development of the investment solution and drive continuous improvement</li><li>Work with internal and external stakeholders to plan and implement the investment solution</li></ul>Candidate Profile:<ul><li>Relevant experience in a discretionary investment management business</li><li>Experience designing and managing investment solutions for retail and wholesale clients</li><li>Knowledge of retail investment vehicles including ICAV and OEIC</li><li>Self-starter with the ability to work in a fast-paced, entrepreneurial environment</li></ul>Mason Blake acts as an employment agency for permanent recruitment and employment business for the supply of temporary workers. Mason Blake is an equal opportunities employer and welcomes applications regardless of sex, marital status, ethnic origin, sexual orientation, religious belief or age. Apply for this job<img src="https://www.jobg8.com/Tracking.aspx?jJgsV495VLe9wdCmQ7G5MwzUye60X4EZw" width="0" height="0" />

Investment Solutions & Asset Allocation (Discretionary Wealth Management)- Associate Director

Michael Page

We're seeking a highly organised and proactive Directorate Assistant to support a senior leadership team within a regulatory standards department. This is a varied and rewarding role offering close collaboration with senior stakeholders and the opportunity to contribute to impactful work.Client DetailsOur client is a respected regulatory body committed to promoting high standards, diversity, and access to justice within the legal profession. The Regulatory Standards Department plays a vital role in ensuring that professional standards evolve in response to societal needs, technological change, and consumer expectations. The organisation is driven by values of fairness, independence, and excellence, and fosters a collaborative and inclusive working culture.DescriptionAs Directorate Assistant, you will:<ul><li>Provide diary and administrative support to the Director of Regulatory Standards and senior stakeholders.</li><li>Organise internal and external meetings, including agendas, papers, and minute-taking.</li><li>Support the Supervision Team with case management, record keeping, and visit logistics.</li><li>Assist with recruitment administration and issuing contracts and cover letters.</li><li>Raise purchase orders and support financial processes within the department.</li><li>Coordinate the monthly Directorate newsletter.</li><li>Organise events such as conferences and away days.</li><li>Carry out ad hoc duties as required by the Director and senior team members.</li></ul>Profile <ul><li>A-Level education or equivalent experience.</li><li>Strong administrative and IT skills, including data management and MS Office.</li><li>Excellent communication skills, both written and verbal, with a diplomatic and professional approach.</li><li>Proven ability to manage multiple tasks, prioritise effectively, and meet deadlines.</li><li>High integrity and discretion when handling confidential information.</li><li>A collaborative mindset with the ability to build strong working relationships.</li></ul> Job Offer <ul><li>Hybrid working: minimum 8 days per month in the central London office.</li><li>A values-led culture that supports personal and professional development.</li><li>The opportunity to work closely with senior leaders in a respected regulatory environment.</li><li>A varied and impactful role within a supportive and inclusive team.</li></ul> If you're an organised, proactive professional looking to make a difference in a respected regulatory environment, we'd love to hear from you. Apply today and help shape the future of professional standards. <img src="https://www.jobg8.com/Tracking.aspx?ArXQWHzQuHjs2XljxlVa404wZWmraNzwa" width="0" height="0" />

Directorate Assistant

Explore 107+ Global regulatory affairs associate director cardio metabolic in London United Kingdom this November. Find roles across top companies and apply now to boost your career.

107 global regulatory affairs associate director cardio metabolic jobs IN London United Kingdom

Global Regulatory Affairs Associate Director (Cardio-Metabolic)

Global Regulatory Affairs Associate Director (Cardio-Metabolic)

Therapeutic Area Medical Director

Associate Director - CMC Regulatory Affairs

Chief Medical Officer

Investment Solutions & Asset Allocation (Discretionary Wealth Management)- Associate Director

Directorate Assistant