Senior Principal Scientist, CMC Dossier Development

At Johnson & Johnson,we believe health is everything.

Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented, treated, and cured,where treatments are smarter and less invasive, andsolutions 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 Senior Principal Scientist, Chemistry, Manufacturing & Controls (CMC) Dossier Development, with limited 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 Senior 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.

Key Responsibilities:


* Supports and implements dossier strategy/product development plans with autonomy.


* Leads and supervises dossier authoring activities for early and late-stage regulatory filings with limited or no 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 external partners, influencing alignment on new ideas and approaches.


* Combines technical expertise with managerial skills and may supervise consultants.


* Handles complex projects with potentially accelerated priority, or programs in NDA/BLA phase
...