Associate Director of Regulatory Affairs Strategy

2 weeks ago


Trenton, United States Meet Full time

We are partnering with a growing biotech that is seeking a highly skilled and experienced Associate Director of Regulatory Affairs Strategy to join our Regulatory Affairs team. The successful candidate will play a pivotal role in developing and executing regulatory strategies to support the successful development, registration, and commercialization of our pharmaceutical products globally.

Responsibilities: Develop and execute comprehensive regulatory strategies in alignment with business objectives and regulatory requirements. Lead regulatory activities for assigned projects, including preparing regulatory submissions, managing regulatory interactions with health authorities, and ensuring compliance with applicable regulations and guidelines. Provide strategic regulatory guidance to cross-functional teams throughout the product development lifecycle, from early development to post-marketing activities. Collaborate with internal stakeholders, including R&D, Clinical Development, Quality Assurance, and Commercial teams, to integrate regulatory considerations into overall product development plans. Monitor regulatory landscape and proactively identify potential risks, opportunities, and changes in regulatory requirements that may impact product development or commercialization strategies. Mentor and provide guidance to junior regulatory affairs team members, fostering their professional growth and development.

Qualifications: Bachelor's degree in life sciences or related field required; advanced degree (e.g., Master's, PhD, PharmD) preferred. Minimum of 6 years of experience within the pharmaceutical or biotechnology industry, with at least 3 years of experience in regulatory strategy development. Strong understanding of global regulatory requirements and guidelines for drug development and commercialization, including FDA, EMA, and other major regulatory agencies. Demonstrated track record of successfully leading regulatory activities for pharmaceutical products throughout the product lifecycle. Experience in Oncology preferred

#J-18808-Ljbffr



  • Trenton, United States TANNER & ASSOC INC Full time

    Associate Director, Regulatory Affairs, Advertising & Promotion—New Jersey Tanner and Associates is recruiting an Associate Director, Regulatory Affairs, Advertising & Promotion for a Pharmaceutical Company. This Job is located in New Jersey. Responsibilities: Provides strategic and operational leadership in advertising and promotion for the US market in...


  • Trenton, United States Saviance Technologies Full time

    Pay Rate- *** to *** Onsite - Yes Regulatory Affairs Labeling Associate Level I is needed to support Client business to prepare and review regulatory labeling deliverables based on Reference Listed Drug labeling, FDA Guidance, regulation and Client internal practices. Support labeling review process with a Quality Assurance and data integrity mindset. Apply...


  • Trenton, United States OPEN Health Group Full time

    Associate Director, Medical Strategy Reports to SVP, Medical Strategy Job Summary The Associate Director, Medical Strategy is responsible for providing strategic medical and tactical direction to support all of OPEN Health’s Scientific Communications teams in (1) the development of strategic medical plans and multi-stakeholder scientific communication...


  • Trenton, United States EPM Scientific Full time

    Responsibilities: Lead the development and execution of regulatory strategies for PMA submissions, ensuring alignment with company goals and regulatory requirements. Oversee the preparation, review, and submission of PMA applications to regulatory authorities, including the FDA. Provide guidance and expertise on regulatory requirements, standards, and best...


  • Trenton, United States OPEN Health Group Full time

    Director, Medical Strategy Reports to SVP, Medical Strategy Job Summary The Director, Medical Strategy plays a pivotal role in driving strategic medical direction within OPEN Health’s Scientific Communications practice. This role involves spearheading the development of comprehensive Medical Affairs strategies and corresponding medical plans. Additionally,...


  • Trenton, United States Randstad North America, Inc. Full time

    The GRADS Compliance Specialist contractor is responsible for executing Regulatory and PV compliance activities based on relevant regulations, procedures, and contractual requirements. Through the implementation of quality and compliance tracking too PV, Regulatory, Compliance, Regulatory Affairs, Support, Management, Construction, Staffing


  • Trenton, United States EPM Scientific Full time

    Title : VP of RA/QA (Medical Devices) Location : Remote, but locations must be located in/near New Jersey (International travel 4x year) Industry : Medical Device (Ophthalmology) Compensation : Starting at $200,000 Responsibilities : Manage on and off-shore teams (regulatory and quality assurance/control) Oversee arena system for document control, adverse...


  • Trenton, United States Merck Full time

    **Job Description** **Role and Responsibilities:** We are seeking an experienced talented scientist to join the **Quantitative Pharmacology and Pharmacometrics -** **Immune/Oncology** **(QP2-IO)** team in the role of Associate Director QP2-IO team is part of the Global Clinical Development organization and has oversight over drug development...


  • Trenton, United States Lennar Full time

    Requirements The Director of Marketing is responsible for the oversight and support of the Division marketing and communication strategies with a focus on efficiencies and strategy implementation. The Director of Marketing will work closely with Divi Director, Marketing, Sales Associate, Business Partner, Construction, Business Services, Support, Development


  • Trenton, New Jersey, United States Ferring Holding SA Full time

    US Legal Operations Associate Director page is loadedUS Legal Operations Associate Director,in helping drive and implement operational success of Ferring's US Chief Legal Office (CLO) team, creating strategy, processes, and practices to transform and improve day-to-day efficiency and effectiveness, working in coordination with Global Legal Operations and the...


  • Trenton, United States Ultimate Healthcare Full time

    We are seeking a food service director (who is not classified as a dietitian) to be responsible for the food service function as well as planning and supervising department sanitation and food preparation according to menu planning for our Skilled Nursing Facility. Position will be located in Essex County, NJ. Additional responsibilities include: providing...


  • Trenton, United States Women In Development of Mercer County Full time

    Position Summary: The Development Director is an experienced professional and strategic thinker who will help advance the organization’s mission, guide the organization’s corporate and individual giving fundraising strategy, oversee and execute its related events and relationship-building activities, and manage relationships across fundraising platforms....


  • Trenton, United States Complete Care Management Full time

    Complete Care is a leading long-term care provider dedicated to enhancing the well-being of individuals through compassionate and high-quality healthcare services. With multiple locations across NJ, WI, PA, MD, WV, DE, CT, we are committed to delivering exceptional care and fostering a positive work environment. As the Regional HR Director , you will play a...


  • Trenton, United States BriteLife Recovery Full time

    This is a full-time remote hybrid position with occasional travel Job Summary: The role of the Human Resources Director encompasses the planning, directing, and coordination of all human resource management activities within the organization. The primary objective of the Human Resources Director is to optimize the strategic utilization of human resources...

  • EHS Director

    2 days ago


    Trenton, United States Cps4jobs Full time

    EHS Director/EHS Manager/EHS/Environmental/Health/Safety/Chemical Manufacturing/Chemicals/Engineer/Engineering/Chemical Engineer/EHS Generalist/Regulatory Compliance/EHS Specialist/Construction Materials/Manufacturing/Adhesives/Sealants/PSM/Chemistry/Wastewater Treatment As the EHS Director job responsibilities include, but are not limited to, the...


  • Trenton, United States Promotion In Motion Full time

    Do you love candy and snacks? Are you looking to join an ever evolving and rapidly growing team? PIM Brands might just be exactly what you’re looking for! At PIM, we make the brands you love. Our portfolio of products, from Welch’s Fruit Snacks to Sun-Maid Chocolate Raisins and Sour Jacks Sour Candies are enjoyed by millions of consumers every day. And...


  • Trenton, United States PIM Brands , LLC Defunct Full time

    Job Details Job Location Somerset - Somerset, NJ Position Type Full Time Education Level 4 Year Degree Job Shift All Shifts (1st, 2nd & 3rd) Job Category Management Description Do you love candy and snacks? Are you looking to join an ever evolving and rapidly growing team? PIM Brands might just be exactly what you're looking for! At PIM, we make the brands...

  • Senior Director

    3 weeks ago


    Trenton, United States Enzene Biosciences Full time

    We are looking for a Senior Director, Quality Assurance to lead our US Quality operations and ensure compliance with global regulatory standards and customer expectations. You will be responsible for overseeing the quality systems, processes, and personnel at our state-of-the-art biopharmaceutical manufacturing facility in the US. You will also be a key...

  • Sales Director

    2 weeks ago


    Trenton, United States Mindsprint Full time

    We are seeking a highly experienced Sales/Business Development Associate Director with a minimum of 10-15 years of experience in the industry, specifically in Business Process Services (BPS) and hunting for new business opportunities. This position will be based in the United States. The ideal candidate will have a proven track record of driving sales and...


  • Trenton, United States Rider University Full time

    Assistant Director, Financial Aid Rider University is an Equal Opportunity/Affirmative Action employer dedicated to excellence through diversity. Bookmark this Job Posting |Print Preview |Apply for this Job Posting Details Position Information Requisition Number 24F200020 Position Title Assistant Director, Financial Aid Position Description Provide financial...