Principal Scientist, CMC Dossier Development

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at jnj.com . As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit. Job Function: Discovery & Pre-Clinical/Clinical Development Job Sub Function: Regulatory Science Job Category: Scientific/Technology All Job Posting Locations: Beerse, Antwerp, Belgium, Leiden, South Holland, Netherlands Job Description: The Principal Scientist, Chemistry, Manufacturing & Controls (CMC) Dossier Development, with some managerial guidance, develops the technical eCTD sections for Regulatory CMC dossier applications, coordinating and providing technical oversight for the generation of the CMC dossier of marketing and clinical trial submissions. Coordinates the timeline, virtual document and Quality module generation, while assuming ownership and accountability for business results and solutions. Represents the department on multi-functional project development teams to support regulatory filings and authors/drives sections of the CMC dossier ensuring compliance with regulatory requirements. The Principal Scientist supports technical functions in developing responses to health authority inquiries for clinical trials and marketing applications, ensuring the completeness, accuracy and compliance of data provided for all regulatory submissions. Ensures timely completion of Quality submissions.

Supports and implements dossier strategy/product development plans with autonomy. Leads dossier authoring activities for early and late-stage regulatory filings with some managerial support. Identifies and drives business improvements within the functional organization and collaborates with other departments as needed. Works with CMC/Tech team members, Regulatory, J&J Innovative Medicine Supply Chain, external service providers and internal Discovery, Product Development & Supply customers, as well as Global Clinical Operations and Therapeutic Areas. Collaborates with internal and some external partners, influencing alignment on new ideas and approaches. Combines technical expertise with managerial skills and may supervise consultants. Handles a limited number of standard projects or, with assistance, complex projects with accelerated priority. Challenges the status quo and identifies innovative process improvements. Makes day-to-day operational decisions and allocates resources, while working independently and checking in regularly with a supervisor. Leads functional or cross-functional teams of up to 10 members.

Education: PhD with 3+ years of relevant post-doc experience OR Bachelor's or Master's degree in chemical, biological or pharmaceutical sciences or related fields with 6+ years of relevant experience is required. Experience and Skills: Experience with dossier authoring for synthetic and/or biologic products, with expertise in both or evidenced capacity and willingness to expand knowledge and leadership across modalities is required. Familiarity with CMC (Chemistry, Manufacturing, and Controls) regulatory submissions, eCTD format, and relevant regulatory guidelines (e.g., FDA, EMA) is preferred. Experience handling complex projects, preferably in the pharmaceutical or biotech industry, with a focus on regulatory submissions is preferred. Experience in