Senior Director Regulatory Affairs

Found in: Appcast Linkedin GBL C2 - 3 weeks ago

Princeton, United States SUN PHARMA Full time

The Brands and Innovative Medicines Global Regulatory Affairs organization is seeking a Senior Director, Global Regulatory Portfolio Leader. Working with leaders across the organization, this individual will provide leadership for the regulatory strategy of one or more in-line and pipeline assets in one or more therapeutic areas and develop a team of US and/or global regulatory leaders (as assigned). Where possible, and leveraging contemporary mechanisms, a key goal for the role is to ensure the conceptualization, development and implementation of efficient global registration pathways to secure approval as well as maintain and (potentially) expand licenses in one and (typically) more geographies. The role will be a key member of the Global Regulatory Affairs Leadership Team, reporting directly to the VP/Head, Global Regulatory Affairs.


Primary Responsibilities:

  • Serve as key corporate regulatory contact and source of regulatory information and guidance for US and other markets as applicable; may serve as US Agent.
  • Serve as a line manager: constructing and developing a team (as resources are assigned)
  • Provide strategic, tactical, and operational direction and guidance for product’s pipeline and key regulatory milestones.
  • Responsible for developing, executing, and maintaining the regulatory commitments and requirements for assigned programs.
  • Stay abreast of regulatory agency regulations, directives, guidelines and policies, etc. that could have an impact on product development to assess approval pathways and issues.
  • Identify and communicate all issues to management related to product development that could impact product submission, approval, and product launch.
  • Set and monitor submission timelines along with other key stakeholders.
  • Facilitate and lead all communications with Regulatory Agencies / Health Authority as applicable.
  • Ensure communication with the regulatory body is in accordance with established procedure within the department.
  • At times, there may be the need for other functional areas to have a discussion with the Health Authority with their counterparts at the regulatory agency. The Regulatory Strategist/Lead should always be the point of contact and lead this interaction.
  • Ensure that communication that is documented per established procedure should be distributed within the Global Regulatory Affairs team and any other external department that is directly affected by the communication.
  • Must be involved in writing or to facilitate the authoring of certain regulatory sections of product submissions.
  • Develops and manages relationships with external regulatory agencies, industry groups and business partners.
  • As applicable, shall review the audit reports, Regulatory Agency inspection reports and responses to the inspection observations if any, when received.
  • To compile, prepare, and review regulatory submissions to regulatory agencies as applicable.
  • Conduct department level training, as necessary, to educate regulatory strategists and other roles in the department on regulatory requirements, policies, and procedures.
  • Participate in authoring and/or reviewing of the departmental procedure as applicable.

Qualifications:

  • Extensive global regulatory leadership as demonstrated by experience (> 15 years), milestones reached (e.g., original/supplemental approvals, expedited program designations), and health authority engagements (e.g., FDA, EMA, and others)
  • Strong staff and organizational development experience (e.g., building teams, and coaching and training both new and experienced staff); demonstrated strengths in delegation, resource allocation, and workload prioritization.
  • Broad experience in and across regulatory disciplines (notably global/regional strategy, labeling, clinical, nonclinical, CMC)
  • Direct experience and expertise in authoring and filing regulatory documentation across major regulated markets.
  • Ability and interest in building and/or working a nimble resourcing environment.


Education:

  • Advanced degree preferred (PhD, MD, PharmD, MBA, JD)

  • Director of Regulatory Affairs

    2 weeks ago

    Princeton, United States BioPhase Full time

    Hybrid - 3 days a week in office - Princeton, NJ The Associate Director of Regulatory Affairs Labeling will assist in the development of a cross-functional labeling strategy for products worldwide, including providing expert input on labeling requirements and strategic guidance during label development, facilitating cross functional labeling discussions...

  • Director of Regulatory Affairs

    6 days ago

    Princeton, United States BioPhase Full time

    Hybrid - 3 days a week in office - Princeton, NJ The Associate Director of Regulatory Affairs Labeling will assist in the development of a cross-functional labeling strategy for products worldwide, including providing expert input on labeling requirements and strategic guidance during label development, facilitating cross functional labeling discussions...

  • Director of Regulatory Affairs

    Found in: Appcast US C2 - 2 weeks ago

    Princeton, United States BioPhase Full time

    Hybrid - 3 days a week in office - Princeton, NJ The Associate Director of Regulatory Affairs Labeling will assist in the development of a cross-functional labeling strategy for products worldwide, including providing expert input on labeling requirements and strategic guidance during label development, facilitating cross functional labeling discussions with...

  • Executive Director, Head of Regulatory Affairs

    2 weeks ago

    Princeton, United States pmvpharma Full time

    Job DescriptionJob DescriptionPMV Pharmaceuticals Inc.Job Description: Executive Director, Head of Regulatory AffairsReports to: Chief Development OfficerLocation: Hybrid (2 days a week in Princeton, NJ office)Position OverviewThe Executive Director, Head of Regulatory Affairs position will provide regulatory expertise and leadership to ensure that the...

  • Executive Director, Head of Regulatory Affairs

    3 days ago

    Princeton, United States pmvpharma Full time

    Job DescriptionJob DescriptionPMV Pharmaceuticals Inc.Job Description: Executive Director, Head of Regulatory AffairsReports to: Chief Development OfficerLocation: Hybrid (2 days a week in Princeton, NJ office)Position OverviewThe Executive Director, Head of Regulatory Affairs position will provide regulatory expertise and leadership to ensure that the...

  • Executive Director, Head of Regulatory Affairs

    2 weeks ago

    Princeton, United States pmvpharma Full time

    PMV Pharmaceuticals Inc. Job Description: Executive Director, Head of Regulatory Affairs Reports to: Chief Development Officer Location: Hybrid (2 days a week in Princeton, NJ office)Position Overview The Executive Director, Head of Regulatory Affairs position will provide regulatory expertise and leadership to ensure that the company meets its objectives....

  • Director Regulatory Affairs Strategy

    2 weeks ago

    Princeton, United States Lynkx Staffing LLC Full time

    Job DescriptionJob DescriptionOur Pharmaceutical client seeks a Global Director Regulatory Affairs Strategy to guide global teams through the development and execution of regulatory strategy and the design of CMC components of drug development programs in collaboration with counterparts, investigators, project team members, and consultants. Lead/support...

  • Director Regulatory Affairs Strategy

    3 weeks ago

    Princeton, United States Lynkx Staffing LLC Full time

    Job DescriptionJob DescriptionOur Pharmaceutical client seeks a Global Director Regulatory Affairs Strategy to guide global teams through the development and execution of regulatory strategy and the design of CMC components of drug development programs in collaboration with counterparts, investigators, project team members, and consultants. Lead/support...

  • Director Regulatory Affairs Strategy

    3 days ago

    Princeton, United States Lynkx Staffing LLC Full time

    Job DescriptionJob DescriptionOur Pharmaceutical client seeks a Global Director Regulatory Affairs Strategy to guide global teams through the development and execution of regulatory strategy and the design of CMC components of drug development programs in collaboration with counterparts, investigators, project team members, and consultants. Lead/support...

  • Director Regulatory Affairs Strategy

    3 days ago

    Princeton, United States Lynkx Staffing LLC Full time

    Job DescriptionJob DescriptionOur Pharmaceutical client seeks a Global Director Regulatory Affairs Strategy to guide global teams through the development and execution of regulatory strategy and the design of CMC components of drug development programs in collaboration with counterparts, investigators, project team members, and consultants. Lead/support...

  • Associate Director of Regulatory Affairs

    Found in: Appcast Linkedin GBL C2 - 3 weeks ago

    Princeton, United States BioPhase Full time

    Hybrid - 3 days a week in office - Princeton, NJ The Associate Director of Regulatory Affairs Labeling will assist in the development of a cross-functional labeling strategy for products worldwide, including providing expert input on labeling requirements and strategic guidance during label development, facilitating cross functional labeling discussions with...

  • Regulatory Affairs Compliance and Planning- Project Manager

    2 weeks ago

    Princeton, United States Kyowa Hakko Kirin Full time

    The Project Manager, Global Regulatory Affairs Compliance and Planning will lead or support regional and global projects by effectively delivering assigned projects within GRA on time and within budget. This individual will support the develop of per Project Manager, Regulatory Affairs, Compliance, Planning, Manager, Regulatory, Business Services

  • Vice President Regulatory Affairs Quality Assurance

    Found in: Appcast US C2 - 2 weeks ago

    Princeton, United States Afton Consulting Group Full time

    Vice President of Regulatory Affairs & Quality AssuranceAre you a seasoned expert in pharmaceutical regulatory affairs and quality assurance? Do you crave the challenge of leading these critical functions within a dynamic, innovative organization? If so, this opportunity could be a pivotal career move.The Role:The Vice President of Regulatory Affairs &...

  • Vice President Regulatory Affairs Quality Assurance

    2 weeks ago

    Princeton, United States Afton Consulting Group Full time

    Vice President of Regulatory Affairs & Quality AssuranceAre you a seasoned expert in pharmaceutical regulatory affairs and quality assurance? Do you crave the challenge of leading these critical functions within a dynamic, innovative organization? If so, this opportunity could be a pivotal career move.The Role:The Vice President of Regulatory Affairs &...

  • Vice President Regulatory Affairs Quality Assurance

    Found in: Jooble US O C2 - 2 weeks ago

    Princeton, NJ, United States Afton Consulting Group Full time

    Vice President of Regulatory Affairs & Quality Assurance Are you a seasoned expert in pharmaceutical regulatory affairs and quality assurance? Do you crave the challenge of leading these critical functions within a dynamic, innovative organization? If so, this opportunity could be a pivotal career move. The Role: The Vice President of Regulatory Affairs...

  • Freelance Senior Regulatory Specialist

    Found in: Appcast Linkedin GBL C2 - 1 week ago

    Princeton, United States MRM Full time

    Job Title: Senior Regulatory Operations SpecialistAbout this role:The Senior Regulatory Operations Specialist position is an integral part of MRM for Health and the Regulatory Operations capability. Regulatory Operations is accountable and responsible for the preparation, review, and submission of regulatory packages to Client Medical, Legal and Regulatory...

  • Regulatory Business Analyst

    Found in: beBee S US - 3 weeks ago

    Princeton, United States QData Full time

    10+ Years of experience is mandatory. The Business Analyst will engage and partner with cross-functional business teams to gather business requirements perform gap analysis develop functional requirements define solution recommendations draft business cases perform vendor research partner with internal and external development and testing teams to...

  • Regulatory Business Analyst

    Found in: beBee jobs US - 3 weeks ago

    Princeton, New Jersey, United States QData Full time

    10+ Years of experience is mandatory. The Business Analyst will engage and partner with cross-functional business teams to gather business requirements perform gap analysis develop functional requirements define solution recommendations draft business cases perform vendor research partner with internal and external development and testing teams to execute...

  • Medical Affairs Consultant

    4 days ago

    Princeton, United States Clinical Resource Network (CRN) Full time

    Our client is looking to fill the role of Medical Affairs Consultant. This position will be fully remote.Responsibilities:Collaborating with Medical Affairs colleagues and external vendors to execute asset strategy and tactical plans with appropriate use of resources and according to developed timelinesTracking priority Medical Affairs tactics and...

  • Principal Regulatory Strategist

    3 days ago

    Princeton, United States MMS Full time

    Job DescriptionJob DescriptionMMS is an innovative, data-focused CRO that supports the pharmaceutical, biotech, and medical device industries with a proven, scientific approach to complex trial data and regulatory submission challenges. Strong industry experience, technology-enabled services, and a data-driven approach to drug development make MMS a valuable...