Senior Principal Scientist, CMC Dossier Development

Johnson & Johnson; Leiden; On-site; EUR 96,000 - 165,000; Full time

Benefits offered by this job

Annual bonus

Vacation days

Parental leave

Well-being reimbursement

Insurance plans

Job summary

Johnson & Johnson in Leiden, Netherlands, invites a Senior Principal Scientist, Chemistry, Manufacturing & Controls (CMC) Dossier Development, to lead regulatory CMC dossiers for marketing and clinical submissions. You will coordinate timelines, author sections, and ensure regulatory compliance across FDA/EMA guidelines.

You will supervise dossier authoring activities, work with multi-disciplinary teams, and drive strategic plans for product timelines while mentoring colleagues and delivering

Qualifications

• PhD with 6+ years post-doc or equivalent in chemical/biological/pharmaceutical sciences.
• Experience leading CMC dossier authoring for synthetic or biologic products.
• Familiarity with FDA/EMA regulatory guidelines and eCTD.
• Experience coordinating regulatory submissions and cross-functional teams.

Responsibilities

• Supports dossier strategy and development plans with autonomy.
• Leads dossier authoring for early and late-stage regulatory filings with limited supervision.
• Drives business improvements within the function and with other departments.
• Collaborates with CMC, Regulatory, Supply Chain, and external partners.
• Influences alignment on new ideas and approaches with partners.
• Combines technical expertise with managerial skills; may supervise consultants.
• Handles complex projects or NDA/BLA programs with accelerated priority.
• Identifies innovative process improvements and challenges status quo.
• Makes day-to-day decisions and allocates resources; reports to supervisor.
• Leads functional or cross-functional teams of up to 15 members.

Skills

Dossier leadership

CMC regulatory submissions

eCTD knowledge

Project leadership

Cross-functional collaboration

Regulatory writing

Strategic planning

Team mentoring

Communication skills

Analytical thinking

Independent work

Education

PhD with 6+ years post-doc

Bachelor's/Master's in chemical/biological/pharma with 8+ years

Job description

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
• Challenges the status quo and identifies innovative process improvements.
• Makes day-to-day operational decisions and allocates resources, while working independently and checking in as needed with a supervisor.
• Leads functional or cross-functional teams of up to 15 members.

Qualifications

Education

• PhD with 6+ years of relevant post-doc experience OR Bachelor's or Master's degree in chemical, biological or pharmaceutical sciences or related fields with 8+ years of relevant experience is required.

Experience And Skills

• Proven ability to lead 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 required.
• Experience handling complex projects, preferably in the pharmaceutical or biotech industry, with a focus on regulatory submissions is required.
• Experience in writing or leading all aspects of the preparation of regulatory CMC documents, including CMC sections for marketing and clinical trial submissions is required.
• Experience collaborating with various departments and external partners in a multi-disciplinary environment is required.
• Ability to develop and implement strategic plans related to dossier development and product timelines is preferred.
• Skills in leading teams or projects, mentoring colleagues, and coordinating resources effectively is required.
• Excellent written and oral communication skills with the ability to communicate complex technical information to diverse partners is required.
• Strong analytical and problem-solving abilities to identify and implement business improvements and innovations is required.
• Ability to work independently, handle multiple priorities, and adapt to changing project needs is required.

The anticipated pay range for this position, in the primary posting location, is:

€96,000.00 - €165,025.00

The anticipated pay ranges for additional locations are:

The anticipated base pay range for this position is 82.900 – 144.210 EUR

Benefits

In addition to base pay, we offer the following benefits*: an annual bonus with set target (% of pay) depending on pay grade / location, where the actual amount is based on the employees’ and companies’ performance of the previous calendar year, or sales commissions. Moreover, we offer vacation days, parental leave for a minimum of 12 weeks, bereavement leave, caregiver leave, volunteer leave, well-being reimbursement, programs for financial, physical and mental health. We also offer service anniversary and recognition awards, and subject to the terms of their respective plans, employees - and in some location’s eligible dependents - can participate in several insurance plans. For more information, visit Employee benefits | Supporting well-being & career growth | Johnson & Johnson Careers.

• This is for informative purposes only. Amounts and actual benefits may vary by location and are subject to change.