Senior Principal Scientist, CMC Dossier Development

Leiden Bio Science Park; Netherlands; On-site; EUR 120,000 - 180,000; Full time

Job summary

Leiden Bio Science Park is seeking a Senior Principal Scientist, Chemistry, Manufacturing & Controls (CMC) Dossier Development. You will develop technical eCTD sections for regulatory dossiers and oversee cross-functional teams to ensure compliant submissions.

The role requires leading dossier authoring for synthetic or biologic products, with strong CMC regulatory knowledge and excellent communication skills.

Qualifications

• Proven ability to lead dossier authoring for synthetic and/or biologic products.
• Familiar with CMC regulatory submissions, eCTD format and relevant guidelines.
• Experience managing complex regulatory submissions in pharma/biotech.
• Experience collaborating across departments and external partners.
• Strong written and verbal communication with leadership potential.

Responsibilities

• Supports dossier strategy and product development plans with autonomy.
• Leads dossier authoring activities for regulatory filings with limited supervision.
• Identifies and drives business improvements within the function.
• Collaborates with Regulatory, Supply Chain, and cross-functional teams.
• Influences alignment with internal and external partners.
• Mentalities combine technical and managerial skills, may supervise consultants.
• Manages complex projects with potentially accelerated priority.
• Challenges the status quo and identifies process improvements.
• Makes day-to-day decisions and allocates resources independently.

Skills

Dossier authoring

Regulatory submissions

eCTD

CMC

Leadership

Project management

Cross-functional collaboration

Regulatory knowledge

Technical writing

Quality awareness

Education

PhD (6+ yrs post-doc)

Bachelor's degree

Master's degree

Job description

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.