Senior Director Regulatory Affairs Liaison- General Medicine Merck & Co IncSenior Director Regulatory Affairs Liaison- General MedicineUpper Gwynedd, PA$190,800–$300,300 / yearRequired Skills: Corporate Commercial, Cross-Cultural Awareness, Drug Development, Exercises Judgment, Global Health, Global Market, Healthcare Innovation, Interpersonal Relationships, In Vitro Diagnostics (IVD), Multiple Therapeutic Areas, Oral Communications, Orphan Drugs, Pharmaceutical Regulatory Affairs, Process Improvements, Regulatory Affairs Compliance, Regulatory Affairs Management, Regulatory Communications, Regulatory Compliance, Regulatory Issues, Regulatory Management, Regulatory Strategy Development, Written Communication. As the Global Regulatory Lead (GRL), the Senior Principal Scientist functions as the regulatory single, accountable, global point of contact on the project team and interacts with the global regulatory agencies and/or subsidiaries with regard to global regulatory strategy/registration requirements for one or more company investigational and marketed drugs/biologics in early- and/or late-stage development.
Associate Director, Promotional Regulatory Affairs AstraZeneca PlcAssociate Director, Promotional Regulatory AffairsWilmington, DE$150,098–$225,147 / yearAs the Associate Director Promotional Regulatory Affairs, you will ensure efficient and effective regulatory review and risk assessment of promotional material for all segments (HCP, Consumer, Managed Markets) and media (Print, broadcast and electronic), sales training, faculty training, Proactive Scientific Exchange by SciP, Corporate Affairs communications, and any other materials required to be reviewed through AZAP. The Associate Director Promotional Regulatory Affairs will work with a with a cross-functional review team and provide regulatory guidance and risk assessment to help business teams develop and deliver initiatives that are intended to comply with applicable laws, rules and regulations governing the advertising and promotion of pharmaceutical products in the US.
Associate Director, Commercial Regulatory Affairs Bristol-Myers Squibb CoAssociate Director, Commercial Regulatory AffairsPrinceton, NJ$173,350–$210,058 / yearResponsibilities include: Provides regulatory advice, risk assessment and mitigation strategies to Commercial Teams, Medical Affairs, Public Affairs, Value Access and Payment, and other internal groups, on all promotional materials, including concepts, disease awareness, and institutional campaigns on assigned product/therapeutic area. Description: The role of Associate Director of US Commercial Regulatory Affairs requires the ability to apply complex scientific and expert regulatory advice and risk assessment for the development of promotional campaigns and materials for an assigned product/therapeutic area in order to help ensure the Company's objectives are met.
Associate Director Regulatory Affairs, Oncology GSK plcAssociate Director Regulatory Affairs, OncologyCollegeville, PA$138,750–$231,250 / yearThis role will ensure the development of appropriate global and/or regional regulatory strategy(s) and their execution for assigned asset(s) consistent with Medicines Development Strategy /Integrated Asset plan to ensure the development program meets the needs of the key markets identified and the Medicines Profile. Work with the Early/Medicine Development Team (EDT/MDT) or GRL, to ensure a robust regulatory strategy is in place to support the development program to meet the needs of the key markets identified in the Integrated Asset plan and the Medicine Profile.
Associate Director, Regulatory Affairs Project Planning & Coordination ACADIA Pharmaceuticals Inc.Associate Director, Regulatory Affairs Project Planning & CoordinationPrinceton, NJ$154,000–$193,000 / yearWe are developing the next wave of therapeutic advancements with a robust and diverse pipeline that includes mid- to late-stage programs in Alzheimer's disease psychosis and Lewy body dementia psychosis, along with earlier-stage programs that address other underserved patient needs. The Associate Director, Regulatory Affairs Project Planning & Coordination is responsible for developing, implementing, and monitoring project plans and best practices that facilitate how the Global Regulatory Affairs department executes its strategic and functional goals.
Executive Director, Regulatory Affairs Liaison Merck & Co IncExecutive Director, Regulatory Affairs LiaisonNorth Wales, PA$231,900–$365,000 / yearRequired Skills: Accountability, Accountability, Business Development, Communication, Complaint Management, Cross-Cultural Awareness, External Communication, Global Health, Global Regulatory, Leadership, Oncology Drug Development, Ophthalmology, People Management, Pharmaceutical Regulatory Affairs, Professional Integrity, Project Resource Allocation, Project Tasks, R&D Strategy, Regulatory Affairs Compliance, Regulatory Affairs Management, Regulatory Compliance, Regulatory Experience, Regulatory Filings, Regulatory Strategy Development, Resource Allocation {+ 3 more}. Provide oversight for direct reports and support them to function as the single global point of accountability for assigned projects, partnering closely with international regulatory colleagues and engaging global health authorities to deliver on Company priorities.
Director, Global Regulatory Affairs Lead (Oncology) GSK plcDirector, Global Regulatory Affairs Lead (Oncology)Collegeville, PA$171,750–$286,250 / yearProven track record of facilitating groups of individuals to work together on creating solutions and developing regulatory strategies, proactively seeking information and insight from a broad range of sources and weight benefits and risks before making important decisions. Works with the respective GRS TG Portfolio Lead and TG VP to ensure a robust regulatory strategy and appropriate TG resource is in place to support respective development programs to meet the needs of the key markets identified in the IES and the Medicine Profile.
Senior Director, Regulatory Affairs (Ad Promo) Bausch Health Companies IncSenior Director, Regulatory Affairs (Ad Promo)Philadelphia, PA$215,000–$296,000 / yearRepresents regulatory affairs in cross functional prescription product promotional review teams as required, participate in development committees for processes and procedures relating to ad promo. Job Location: Washington, District of Columbia, USA | Boston, Massachusetts, USA | Bridgewater, New Jersey, USA | NewYorkCity, New York, USA | Philadelphia, Pennsylvania, USA.
Director/Sr. Director/Executive Director, Clinical Regulatory Affairs SystimmuneDirector/Sr. Director/Executive Director, Clinical Regulatory AffairsPrinceton, NJ$200,000–$300,000 / yearThe Regulatory Affairs (Clinical/Nonclinical) role will drive regulatory strategy and execution within SI Project development teams and the RA Department in all aspects of global regulatory affairs related to development of novel oncology therapeutics (multiple modalities such as ADCs, bispecific antibodies and T-cell engagers etc.). Own/drive the preparation, submission, management and maintenance of global regulatory submissions related to clinical and nonclinical aspects of product development, including, but not limited to, the following: BLA/INDs/CTAs, amendments and information requests, Orphan drug applications, Annual Reports and Investigator’s Brochure.
Director/Sr. Director/Executive Director, Clinical Regulatory Affairs SystImmune, Inc.Director/Sr. Director/Executive Director, Clinical Regulatory AffairsPrinceton, NJ$200,000–$300,000 / yearThe Regulatory Affairs (Clinical/Nonclinical) role will drive regulatory strategy and execution within SI Project development teams and the RA Department in all aspects of global regulatory affairs related to development of novel oncology therapeutics (multiple modalities such as ADCs, bispecific antibodies and T-cell engagers etc.). Own/drive the preparation, submission, management and maintenance of global regulatory submissions related to clinical and nonclinical aspects of product development, including, but not limited to, the following: BLA/INDs/CTAs, amendments and information requests, Orphan drug applications, Annual Reports and Investigator's Brochure.
Manager, Product Stewardship & Regulatory Affairs AzelisManager, Product Stewardship & Regulatory AffairsWest Chester, PennsylvaniaTeamwork - Balances team and individual responsibilities; Exhibits objectivity and openness to others' views; Gives and welcomes feedback; Contributes to building a positive team spirit; Puts success of team above own interests; Able to build morale and group commitments to goals and objectives; Supports everyone's efforts to succeed. Problem Solving - Identifies and resolves problems in a timely manner; Gathers and analyzes information skillfully; Develops alternative solutions; Works well in group problem solving situations; Uses reason even when dealing with emotional topics.
NewSenior Director, Regulatory Affairs Immunocore Holdings PlcSenior Director, Regulatory AffairsRadnor, PA$250,000–$270,000 / yearVacancy NameSenior Director, Regulatory Affairs Vacancy NoVN870 Employment TypeFull Time Location of roleGaithersburg, MD, Radnor, PA DepartmentRegulatory Affairs Key ResponsibilitiesThe Senior Director of Regulatory Affairs will be responsible for assigned projects and all of the regulatory affairs activities by providing expertise to Immunocore's development programs to include regulatory scientific and tactical strategy development, IND development/submission/maintenance, BLA/sBLA development/submission/maintenance, agency liaison and regulatory intelligence. $250,000- $270,000 About the CompanyImmunocore (NASDAQ: IMCR) is a pioneering, commercial-stage T cell receptor biotechnology company whose purpose is to develop and commercialize a new generation of transformative medicines which address unmet patient needs in oncology, infectious diseases and autoimmune disease.
Head of Government and Regulatory Affairs Resolution Life Group Holdings LtdHead of Government and Regulatory AffairsWest Chester, PA$285,000–$440,000 / yearThe Head of Government and Regulatory Affairs will be accountable for establishing and operating a coordinated government and regulatory affairs function, including identifying and assessing legislative, regulatory, supervisory, and public policy developments that may affect Resolution Life, developing and implementing results-drive advocacy strategies to advance key business priorities, coordinating regulatory and government engagement, and representing the company with regulators, government officials, industry forums, and trade associations. The role will report to the Head of Legal & Compliance and will also work closely with the Chief Executive Officer, North America, Chief Risk Officer, Chief Legal, People & Partnerships Officer, and other senior leaders across the global business.
Senior Director, Regulatory Affairs ICON PlcSenior Director, Regulatory AffairsBlue Bell, PAAs a Senior Director, Regulatory Affairs at ICON, you will provide strategic direction and management of Regulatory Affairs teams (up to 80 team members) and projects and contribute to the strategic direction and overall management of the Regulatory Affairs function at ICON strategic solutions. Key responsibilities include: Lead and oversee the regulatory affairs strategy for ICON's therapeutic area teams as a departmental leader, set a clear and convincing future direction, while communicating with clarity.
Senior Specialist, Regulatory Affairs West Pharmaceutical ServicesSenior Specialist, Regulatory AffairsExton, PAWest solved the problem of supplying penicillin in mass quantities to the US Government during World War 2. Through our work to deliver thousands of life-saving and life-enhancing injectable medicines to millions of patients daily, West's indelible mark on the healthcare industry has just begun. Ability to assess, plan, schedule and manage multiple long-term and short-term projects, tasks, responsibilities and/or priorities in a concurrent fashion with several parallel deliverables and execute deliverables to time-line commitments.
Director, Regulatory Affairs, Ex-US Larimar Therapeutics IncDirector, Regulatory Affairs, Ex-USPAProvide tactical advice to project teams, functional heads and other stakeholders to achieve timely and efficient program development, submissions and approval, while ensuring compliance with applicable global regulatory requirements • Lead regulatory submissions to ex-US health authorities (medicine regulatory and reimbursement groups) to ensure high-quality, timely submissions that align with Larimar's global regulatory strategy and plan • Collaborate with colleagues in Commercial, Medical, Legal, Compliance and other expertise areas in creation of advertising and promotional materials as assigned; and preparation of timely OPDP submissions • Prepare Larimar impact assessment of global regulatory intelligence including but not limited to ICH and global Health Authority guidances, global Health Authority Pilot programs and initiatives, rare disease product approvals, and FDA advisory committee meetings • Develop internal regulatory procedures and practices • Work closely with RA Sr. Requirements: Key Experience, Skills and Knowledge: • Minimum of 4-year undergraduate degree • 5 to 8 years' experience in a Regulatory Affairs role in the pharmaceutical industry, experience with EMA, MHRA and other local European agencies preferred • Understanding of GxP systems and Quality principles • Ability to research global regulatory guidance (nonclinical, clinical and CMC) and precedence to assist in the development and execution of global regulatory strategies • Experience with preparation (authoring and review) of documents for global Health Authority submissions including but not limited to IND amendments, CTA submissions, Global Health Authority Meeting packages and global marketing authorization applications • Excellent communication, time management and project management skills • Continuous quality improvement mindset and attention to details • Can do attitude, flexibility, and mental agility.
Senior Analyst - Compliance & Regulatory Affairs AXA SASenior Analyst - Compliance & Regulatory AffairsEXTON, PA$64,600–$107,300 / yearBy combining a comprehensive and efficient capital platform, data-driven insights, leading technology, and the best talent in an agile and inclusive workspace, empowered to deliver top client service across all our lines of business - property, casualty, professional, financial lines and specialty. You will report to the Manager Regulatory Compliance Services What you will BRING Were looking for someone who has these abilities and skills: Required Skills and Abilities Property & Casualty Insurance experience in the field of regulatory compliance, state filings, product development, underwriting or underwriting support.
Vice President, Global Regulatory Affairs, Team Lead, Strategy Genmab ASVice President, Global Regulatory Affairs, Team Lead, StrategyPrinceton, NJFor 25 years, its hard-working, innovative and collaborative team has invented next-generation antibody technology platforms and harnessed translational, quantitative and data sciences, resulting in a proprietary pipeline including bispecific T-cell engagers, antibody-drug conjugates, next-generation immune checkpoint modulators and effector function-enhanced antibodies. The Vice President, Global Regulatory Affairs Strategy is a key leadership role within Global Regulatory Affairs, responsible for managing the regulatory strategy and regulatory deliverables for a portfolio of assets across all stages of development.
Sr Mgr, Regulatory Affairs CMC KaztronixSr Mgr, Regulatory Affairs CMCDelware County, PARemoteThe Senior Manager, Regulatory Affairs, CMC will primarily be responsible for managing regulatory CMC submissions and strategy for development and marketed products, for biologic/small molecules, from early development through late-stage (phase 3, registration and post-approval). Experience with global clinical trial and marketing applications, eCTD submissions, electronic document management systems (e.g., Veeva Vault platform), and Starting Point and Microsoft Word Templates.
EG-140 - Regulatory Affairs / Medical Writing Bristol-Myers Squibb CoEG-140 - Regulatory Affairs / Medical WritingPrinceton, NJ$170,880–$207,061 / yearBased on eligibility*, additional time off for employees may include unlimited paid sick time, up to 2 paid volunteer days per year, summer hours flexibility, leaves of absence for medical, personal, parental, caregiver, bereavement, and military needs and an annual Global Shutdown between Christmas and New Years Day. Demonstrated expert writing skills in authoring and managing the production of clinical and regulatory document including registrational submission documents (eg, briefing documents, CTD summary documents, responses, pediatric plans).