Director - Global Regulatory Strategy
1 month ago
Description
Summary
Serves as a key regulatory interface with Global Health Authorities and acts as global regulatory lead for product brand teams to develop, maintain and obtain alignment of global regulatory strategies in accordance with business plans. The incumbent is expected to exhibit leadership behaviors consistent with level and to act with a high degree of flexibility and prompt response in a fast-paced work environment. In addition, the role ensures compliance with global regulatory requirements and proactively anticipates and mitigates regulatory risks.
Principal Responsibilities
As Regulatory and PV Program Head (RPH), leads the Regulatory Affairs and PV (RAPV) project team for development and marketed products. Key internal leader and driver of regulatory objectives and strategy for assigned products.
Acts as the single point of accountability for RAPV for assigned projects within the R & D Organization and with key internal stakeholders including commercial and operations.
Responsible for preparation and maintenance of written global regulatory strategy plans, risk registers and mitigation plans and written assessments of product probability of regulatory success.
Leads preparation of Global regulatory dossiers for new product registrations and supplements, variations and amendments for assigned products. Prioritizes project deliverables and ensures that submission timelines are realistically prepared and met.
Ensures the key deliverables for the role: regulatory support of clinical development for new indications, overall regulatory strategy for manufacturing initiatives and management of label updates. Communicates to regulatory team and cross-functionally the immediate to long-range plans to carry out regulatory objectives thereby ensuring that corporate product goals are met.
Works independently on complex issues under the direction of senior regulatory leadership. Makes decisions regarding work processes or operational plans and schedules in order to achieve the program objectives. Ensures that regulatory documents are organized and archived in accordance with all applicable global regulations.
May participate in or lead departmental and business development initiatives. Provides coaching and mentoring for global regulatory project team members. Advances the organization’s goals by participating in professional associations, industry and trade groups as appropriate. Advises management of the effect of current or proposed laws, regulations, guidelines and standards, etc.
Provides input to Resource forecasting for projects, encompassing internal staff as well as external vendors.
Minimum Requirements
Experience / Skills:
Bachelor's degree; preferably in a scientific or technical field; advanced scientific-related degree strongly preferred; MD or PhD in related science field or Master's degree in Regulatory Affairs (or equivalent) desirable.
RAC Certification desirable
10 years drug/device development experience with a minimum of 5-7 years in regulatory
Global and strategic experience preferred
Experience leading teams, mentoring or managerial experience a plus
Rare disease or specialty pharmaceutical experience preferred
Competencies:
Excellent verbal and written communication skills as well as strong interpersonal skills and tactful negotiation skills.
Ability to establish and maintain collaborative relationships with key employees in Regulatory and Pharmacovigilance, R&D, and Medical Affairs; Quality Assurance; Operations; Commercial and Legal, as well as positive interactions with senior management.
Able to lead interdisciplinary teams including partner organizations.
Experience with leading efforts to prepare Marketing Authorization submissions, achieve successful approval, and launch.
Expertise with Health Authority Meetings and negotiations.
Working knowledge of all aspects of regulatory affairs, including CMC, clinical development, statistical concepts, toxicology and non-clinical research, pharmacovigilance aspects and operations; FDA & EU guidelines and regulations with an emphasis registration requirement; experience with Rest of World submission requirements.
Detailed knowledge of content and preparation of all regulatory documents and experience in maintaining regulatory compliance within pharmaceutical industry.
Broad experience with multiple therapeutic area(s) and understanding of business impact of regulatory strategies.
Experience in leading teams and managing junior staff, either directly or indirectly in matrix environment; including coaching & mentoring, setting priorities, giving feedback and positively engaging cooperation.
Addresses issues and challenges rapidly and in a proactive and positive manner.
Knowledge of EDMS systems, regulatory publishing, preparation of regulatory submissions and expertise with Microsoft Office programs
Organizational Relationship/Scope:
Reports to Executive Director of Regulatory Affairs
Working Conditions:
Standard Office environment with minimal (10%) travel. Position may be based in our Irish office in Dublin or based remotely in the United Kingdom or European Union (within limits of Mallinckrodt's jurisdictions).
Disclaimer:
The above statements are intended to describe the general nature and level of work being performed by employees assigned to this classification. They are not intended to be construed as an exhaustive list of all responsibilities, duties and skills required of employees assigned to this position.
#LI-KD1
-
Global Director of Regulatory AffairsNew
2 weeks ago
Dublin, Ireland Next Generation Full timeExciting Opportunity: Global Director of Regulatory Affairs Company Overview: Our client, an expanding global biopharmaceutical company, is at the forefront of innovation in oncology therapeutics. With a commitment to improving patient outcomes, they are expanding their therapeutic portfolio and seeking a talented Global Director of Regulatory Affairs...
-
Dublin, Ireland Gilead Sciences Ireland UC Full timeDescription Director, Global Regulatory Affairs, Pediatrics Dublin, Ireland At Gilead we believe every employee deserves a great leader. As a people leader now or in the future, we expect that you will model and create an environment of inclusion, be intentionally focused on the hiring, development, growth and retention of talent, and empower...
-
Dublin, Ireland Gilead Sciences Full timeJob Description 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...
-
Associate Procurement Director
1 month ago
Dublin, Ireland DSJ Global Full timeDSJ Global is pleased to offer a fantastic opportunity for an experienced procurement professional looking for their next challenge. Our client is seeking an Associate Procurement Director who will be based in our office located in beautiful and vibrant Dublin, Ireland. Key Responsibilities: Lead all aspects of direct and indirect procurement within the...
-
Dublin, Ireland Linesight Full timeGlobal Director of Health and Safety Services Global Director of Health and Safety Services As a Global Director of Health & Safety Services at Linesight, you will work with highly experienced, culturally diverse, and passionate teams nurturing a strong social dynamic and a shared sense of achievement. We will empower, support, and enable you to take...
-
Manager, Regulatory Affairs Global CMC
1 month ago
Dublin, Ireland Viatris Full timeMcDermott Laboratories Limited At VIATRIS, we see healthcare not as it is but as it should be. We act courageously and are uniquely positioned to be a source of stability in a world of evolving healthcare needs. Viatris empowers people worldwide to live healthier at every stage of life. We do so via: Access – Providing high quality trusted medicines...
-
Manager, Regulatory Affairs Global CMC
1 month ago
Dublin, Ireland Viatris inc. Full timeManager, Regulatory Affairs Global CMC page is loaded Manager, Regulatory Affairs Global CMC Apply locations Northern Cross, Dublin, Ireland Ireland Remote Office time type Full time posted on Posted Today job requisition id R5643497 McDermott Laboratories Limited At VIATRIS, we see healthcare not as it is but as it should be. We act courageously and are...
-
Manager, Regulatory Affairs Global CMC
1 month ago
Dublin, Ireland Viatris Full timeManager, Regulatory Affairs Global CMC page is loaded Manager, Regulatory Affairs Global CMC Postuler locations Northern Cross, Dublin, Ireland Ireland Remote Office time type Temps plein posted on Offre publiée aujourd'hui job requisition id R5643497 McDermott Laboratories Limited Chez Viatris, nous envisageons la santé non pas telle qu'elle est...
-
Manager, Regulatory Affairs Global CMC
1 month ago
Dublin, Ireland Viatris Inc. Full timeManager, Regulatory Affairs Global CMC page is loaded Manager, Regulatory Affairs Global CMC Solicitar locations Northern Cross, Dublin, Ireland Ireland Remote Office time type Tiempo completo posted on Publicado hoy job requisition id R5643497 McDermott Laboratories Limited En VIATRIS, vemos la atención médica no como es, sino como debe ser. Actuamos...
-
Digital Strategy Director
1 day ago
Dublin, Ireland Prosperity Full timeWe are seeking a Digital Strategy Director for a prominent strategic communications and public affairs consultancy for their Corporate & Reputation divisions. The chosen candidate will lead the efforts in developing comprehensive digital strategies, aligning with client objectives to enhance consumer and influencer marketing and achieve business goals. ...
-
Global Segment Director
1 month ago
Dublin, Ireland TOMRA Full timeJob Description Seeking individuals with demonstrated experience working with either apples or kiwifruit. We are seeking an experienced professional to take the pivotal role of Global Segment Director at TOMRA Food, reporting to the VP, Head of Customer Value. As the Global Segment Director, you will be responsible for shaping the business strategy...
-
Associate Director
3 weeks ago
Dublin, Dublin City, Ireland GrabJobs Full timeJob summaryAssociate Director - Clinical Regulatory Scientist (Oncology)Full time Posted Yesterday Job seniority: associate level Responsibilities Develop, Update and Execute US and Canada Registration Strategy Initiate and Update Regulatory Strategy Document Assist or lead in the development of regulatory strategy by leveraging scientific, drug/device...
-
Senior Director, Global Patient Safety
4 weeks ago
Dublin, Ireland Regeneron Pharmaceuticals, Inc Full timeReporting to the Global Patient Safety (GPS) Therapeutic Area (TA) Head, the Senior Director, serves as the first point of contact (POC) for all safety related issues for the compound(s) assigned within the therapeutic area (TA). They are the GPS representative on the cross functional Strategic Program Team (SPT) and the Chair of the Safety Management Team...
-
Sr. Director
5 days ago
Dublin, Dublin City, Ireland eli lilly and company Full timeSr. Director - Global Regulatory Scientist - Early Clinical DevelopmentLocation: Ireland, CorkEmployment Type: Full timeAt Lilly, we combine compassion with exploration to enhance the quality of life for individuals worldwide. As a prominent player in the healthcare sector situated in Indianapolis, Indiana, we are dedicated to uncovering and introducing...
-
Sr. Counsel
4 weeks ago
Dublin, Ireland Pinterest Full timeWhat you’ll do:Build and maintain strong relationships with Pinterest’s UK and EU content regulators.Respond to requests for information from global regulators and defend the company in regulatory enforcement matters and litigation.Provide specialised legal guidance to cross-functional partners and other members of the Legal team on intermediary...
-
Associate Director
4 days ago
Dublin, Dublin City, Ireland eli lilly and company Full timeAssociate Director - Clinical Central Services and InnovationAt Lilly, we strive to bring impactful medicines and solutions to individuals worldwide. Join our team based in Indianapolis, Indiana to contribute to our mission of enhancing healthcare and giving back to communities through philanthropy and volunteerism. We are seeking dedicated individuals who...
-
Associate Director
1 month ago
Dublin, Dublin City, Ireland WTW Full timeAt Willis Towers Watson (WTW), we're committed to shaping the future of non-life insurance and risk management. We're seeking a dedicated Non-Life Associate Director to join our Dublin team and be part of something extraordinary. Key ResponsibilitiesConduct non-life reserving analyses and provide expert recommendations. Collaborate with clients and...
-
Data Analytics Director
1 month ago
Dublin, Ireland Innovate Skillsource Full timeDirector Data, Insight & Analytics - Telecommunications IndustryWe are seeking an individual passionate about data to drive and deliver our data strategy across all business lines. Reporting to the Chief Financial Officer, the Director of Data, Insight and Analytics will provide strategic support to our wholesale, retail, and television businesses. Key...
-
Associate Director
3 weeks ago
Dublin, Ireland Edelman Full timeThe Opportunity We are recruiting a senior corporate/B2B consultant to deliver international/ multi market reputation programmes for key clients. The successful candidate will be Associate Director or Account Director level, dependent on experience, advising clients on international as well as domestic communications strategies and devising and executing...
-
Associate Director
1 month ago
Dublin, Dublin City, Ireland Willis Towers Watson Full timeJob DescriptionAt Willis Towers Watson (WTW), we're committed to shaping the future of non-life insurance and risk management. We're seeking a dedicated Non-Life Associate Director to join our Dublin team and be part of something extraordinary.Key ResponsibilitiesConduct non-life reserving analyses and provide expert recommendations. Collaborate with clients...