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Regulatory Affair Director jobs in New Jersey

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ASSOCIATE DIRECTOR, REGULATORY AFFAIRS (ADVERTISING AND PROMOTION)

Provides regulatory review of Advertising and Promotional materials, new campaigns and launch strategies for assigned products. Assures timely and accurate review of Advertising and Promotional material to meet internal timelines...

CompanyBausch Health
AddressBridgewater, NJ
CategorySales/marketing
Date Posted 2 weeks ago See detail

Associate Director, Regulatory Affairs (Advertising and Promotion)

Bausch Health

Bridgewater, NJ

Provides regulatory review of Advertising and Promotional materials, new campaigns and launch strategies for assigned products. Assures timely and accurate review of Advertising and Promotional material to meet internal timelines...

2 weeks ago seen See more...

Director, Regulatory Affairs Strategy - Genetic Medicine

Biospace

Basking Ridge, NJ

Provide interpretation of regulatory authorities feedback, policies and guidelines.. Lead the development of regulatory strategic plans either directly in conjunction with project teams or through your reports. Own the preparation...

a month ago seen See more...

Associate Director, Regulatory Affairs - Inflammation & Immunology

Biospace

Basking Ridge, NJ

Provide interpretation of regulatory authorities feedback, policies and guidelines.. Lead the development of regulatory strategic plans either directly in conjunction with project teams or through your reports. Own the preparation...

a month ago seen See more...

Associate Director - Regulatory Affairs - AD Promo

Biospace

Princeton, NJ

Provide strategic guidance for responsible products and disease states based on current regulatory environment and competitive landscape. Assess risk and advise on mitigation strategies to meet overall business need, while maintai...

a month ago seen See more...

Director, Regulatory Affairs Strategy, Hematology

Biospace

Basking Ridge, NJ

Provide interpretation of regulatory authorities feedback, policies and guidelines. Lead the development of regulatory strategic plans either directly in conjunction with project teams or through your reports. Own the preparation...

2 months ago seen See more...

Director, Regulatory Affairs - Pharmaceuticals

Stryker

Mahwah, NJ

Serves as member of the extended business unit leadership team. Able to effectively communicate, interact, and navigate issues at leadership level. Creates long term regulatory strategy for drug products, provides input on combina...

2 months ago seen See more...

Director, Regulatory Affairs - Advertising, Promotion and Regulatory Compliance

Ferring Pharmaceuticals

Parsippany, NJ

Manage Regulatory Affairs, Advertising & Promotion and Compliance GroupManage the US RA Ad Promo, submission operations, labeling and compliance group staff, including objective setting and career development activities and motiva...

2 months ago seen See more...

Senior Manager, Regulatory Affairs - General Medicine

Biospace

Basking Ridge, NJ

Coordinate 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: INDs/CTAs, amend...

6 days ago seen See more...

Manager Regulatory Affairs

Teva Pharmaceuticals

Parsippany, NJ

Requires a Bachelors degree in Pharmacy Administration, Pharmaceutical Science, Regulatory Affairs, or a related field, and 3 years of Regulatory Affairs experience. Must have 2 years of sterile/ parenteral dosage form experience...

a week ago seen See more...

Senior Manager CMC Regulatory Affairs

Biospace

Basking Ridge, NJ

Responsible for CMC/CP product development activities to lead the regulatory standpoint during early phase, development, submissions and post market requirements. Participate in IOPS cross-functional meetings for program-specific...

2 weeks ago seen See more...

VP/TA Head, General Medicine - Global Regulatory Affairs

Merck

Rahway, NJ

Developing an active engagement strategy with US FDA and global health authorities to advocate advanced regulatory strategies for novel medicines.. Contributing to the continuous improvement of the operating model for regulatory a...

3 weeks ago seen See more...

Director, Global Medical Affairs Strategy and Execution, Specialty Ophthalmology

Johnson & Johnson

Raritan, NJ

GMAF Strategic Plans co-development of a consolidated global Medical Affairs Strategy (MAS) that meets prioritized global and regional strategic imperatives; providing expert knowledge in the MAS planning process; driving the c...

2 weeks ago seen See more...

Global Senior Director Medical Affairs (GDMA) – Daiichi Alliance, Oncology

Merck Sharp & Dohme

Rahway, NJ

$200,200 - $315,100 a year

The Global Senior Director Medical Affairs (GDMA) is responsible for driving execution of scientific & Medical Affairs plans for their assigned Therapy Areas (TA) in key countries and regions. They are impactful members of Product...

2 weeks ago seen See more...

Medical Affairs-Scientific Director CV Renal

Biospace

Plainsboro, NJ

Identify and anticipate potential trends, changes to market conditions and areas of opportunity aligned with Therapeutic Area priorities. Utilizes subject matter expertise and analytical tools to provide deeper customer knowledge...

2 weeks ago seen See more...

Manager - Regulatory Affairs - Therapeutic Area

Biospace

Plainsboro, NJ

Compile and submit responses to FDA communications. MANAGER, THERAPEUTIC AREA: Compile, submit and maintain applications (IND, NDA, Biologics, Devices) to government agencies in support of research and marketed products. Create an...

4 weeks ago seen See more...

Senior Director, Head of Global Medical Affairs for Pulmonary Hypertension

Johnson & Johnson

Raritan, NJ

Provide medical leadership in interactions with external stakeholders (HA bodies, external experts, advisory boards). Execution: Provide leadership, scientific input and guide the development of key Medical Affairs deliverables...

3 weeks ago seen See more...

Associate Director, Scientific Sales Affairs

Merck

Rahway, NJ

Hire, onboard, lead, coach, and motivate field veterinary staff of the Companion Animal Business Unit to build strong customer relationships and advance our company's offerings through medical education and needs discovery.. Provi...

3 weeks ago seen See more...

Senior Associate - Regulatory Affairs

Biospace

Princeton, NJ

Contribute to the preparation, review, approval, and dispatch of global submissions to regulatory applications (pre-submission activities, orphan drug applications, IND/INDs/CTAs/NDAs/MAAs etc.). Support the planning and conduct o...

a month ago seen See more...

USA Regulatory Affairs Specialist Project Lead I Scientific

Adecco

Bridgewater, NJ

$ 88 - $ 89.22 / Hour

Adecco Medical & Science is hiring a remote contract Regulatory Affairs Team Lead for our Pharmaceutical partner based out of Bridgewater, NJ.The anticipated wage for this position is between $88 and $89.22. A possible meeting in...

a month ago seen See more...

Associate Manager, Regulatory Affairs (Hybrid)

Iff Family Of Companies

Hazlet, NJ

Working with a team of regulatory Specialists and Managers. This will require the ability to work in a team environment and contribute to collaborative projects. Providing support for all product compliance/regulatory, product cla...

a month ago seen See more...

Manager, Regulatory Affairs- North America (Hybrid)

Iff Family Of Companies

Hazlet, NJ

Mentoring and working with a team of regulatory Specialists and Managers. This will require the ability to work in a team environment and contribute to collaborative projects. Providing support for all product compliance/regulator...

a month ago seen See more...

Regulatory Affairs Consultant

Katalyst Healthcares And Life Sciences

Rahway, NJ

Develop global regulatory strategies for medical device products to meet business objectives and collaborates across a matrixed organization to ensure global success of products' registration. Participate on product development te...

a month ago seen See more...

Regulatory Affairs Consultant

Katalyst Healthcares & Life Sciences

Rahway, NJ

Develop global regulatory strategies for medical device products to meet business objectives and collaborates across a matrixed organization to ensure global success of products\' registration. Participate on product development t...

a month ago seen See more...

Specialist - Regulatory Affairs

Biospace

Plainsboro, NJ

Therapeutic Area:. Assist Manager/Director in review of labeling for marketed products and new products as assigned. Maintain up-to-date knowledge of data requirements and formats, applicable current SOPs, regulations, and guideli...

2 months ago seen See more...

Manager - Regulatory Affairs - Therapeutic Area

Biospace

Plainsboro, NJ

Compile and submit responses to FDA communications. MANAGER, THERAPEUTIC AREA: Compile, submit and maintain applications (IND, NDA, Biologics, Devices) to government agencies in support of research and marketed products. Create an...

2 months ago seen See more...

Manager Global CMC Regulatory Affairs

Johnson & Johnson

Titusville, NJ

Develops and realize global regulatory strategies for development compounds and marketed products according to scientific and risk-based principles. Participates as regulatory lead on CMC/VCM teams and represents CMC RA by provid...

2 months ago seen See more...

Regulatory Affairs Associate - Drug Products (Princeton, NJ (USA), US)

Laboratoire Guerbet

Princeton, NJ

Participate in pre-submission meetings with FDA in order to agree on potential regulatory pathways, clarification and follow-up of submissions under review. Coordinate preparation, review, submission of e-CTD regulatory dossiers t...

2 months ago seen See more...

Director - Global Regulatory Lead

Biospace

Plainsboro, NJ

Serve as a member of the Global Project Team (GPT) utilizing precedent and experience to develop innovative and flexible approaches to achieve development goals, advise on development strategies, and deliver on associated regulato...

4 weeks ago seen See more...

Director, Regulatory CMC

Biospace

Jersey City, NJ

Develop and implement regulatory strategies for CMC aspects of our pharmaceutical products, including preparing and submitting regulatory submissions to regulatory agencies. Interact with regulatory agencies to ensure compliance w...

4 weeks ago seen See more...

Director, Regulatory Labeling

Biospace

Bridgewater, NJ

CCDS. regional prescribing information (e.g., USPI, SmPC, Japan PI). medication guides. patient information/leaflet/instructions for use. package labels. coordinating with multidiscipline team for US commercial implementation...

a month ago seen See more...

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