Principal Scientist, CMC Regulatory Affairs

jj; Warszawa; On-site; PLN 205,000 - 354,000; Full time

Benefits offered by this job

Annual bonus

Vacation days

Parental leave

Bereavement leave

Caregiver leave

Volunteer leave

Well-being reimbursement

Health programs

Service awards

Insurance plans

Job summary

Johnson & Johnson Innovative Medicine in Warsaw seeks a Principal Scientist to lead Global CMC Regulatory Affairs for synthetics and established modalities, covering pre- and post-approval activities.

You will develop global CMC regulatory strategies, manage submission dossiers for Health Authorities, and collaborate across teams to ensure lifecycle compliance and timely regulatory responses.

Qualifications

• BS in biological, pharmaceutical, chemical or engineering sciences with 8+ years of experience; MS/PhD preferred.
• Experience communicating regulatory requirements.
• Understanding of biology, chemistry or engineering relevant to pharma.
• Experience developing regulatory strategies for global product development.
• Strong verbal and written communication; attention to detail.
• Ability to present regulatory strategy to cross-functional teams.
• Experience interacting with Health Authorities under supervision.
• Knowledge of global HA laws and submission routes.
• Understanding of competitors in development.

Responsibilities

• Be the CMC Regulatory Lead on cross-functional teams and represent Global CMC Regulatory Affairs.
• Develop global submission plans compliant with local regulatory requirements.
• Create and implement global CMC regulatory strategy for synthetic drugs/devices.
• Lead preparation of regulatory dossiers for submission to Health Authorities.
• Develop and get buy-in on CMC regulatory strategy for Health Authority responses.
• Participate in and conduct due diligence/licensing evaluations.
• Drive continuous improvement and communicate issues to management.
• Refine regulatory strategies as new data emerge.

Skills

Regulatory strategy

Regulatory communication

Cross-functional teamwork

Attention to detail

Verbal/written communication

Education

Bachelor's degree in biological, pharmaceutical, chemical or engineering sciences

MS/PhD or PharmD preferred

Job description

Job Function:

Discovery & Pre-Clinical/Clinical Development

Job Sub Function:

Regulatory Science

Job Category:

Scientific/Technology

All Job Posting Locations:

Warsaw, Masovian, Poland

Job Description:

Johnson & Johnson Innovative Medicine is recruiting a Principal Scientist in Global CMC Regulatory Affairs - Synthetics, Established Modalities., covering both pre- and post-approval activities. This position is located in Warsaw, Poland.

The Principal Scientist in CMC Regulatory Affairs will be responsible for the following:

• Participates as the CMC (chemistry, manufacturing and control) Regulatory Lead on CMC/Value Chain Teams and represents Global CMC Regulatory Affairs by providing regulatory expertise and input to team recommendations to facilitate successful product development globally.

• Actively participates on Global Regulatory Team(s) to develop global submission plans that comply with local regulatory requirements and commitments.

• Develops and executes global CMC regulatory strategy for one or more synthetic drugs and/or delivery device, meeting .

• Leads the preparation of regulatory dossiers for submission to Health Authorities.

• Develops and gets buy-in on CMC regulatory strategy for Health Authority responses as needed.
• Participates in selected initiatives within CMC RA / GRA
• Participates in and conducts due diligence/licensing evaluations as needed

• Drives a culture of continuous improvement to ensure compliance with Johnson & Johnson standards, regulatory requirements and expectations. Communicates critical issues to Management

Sphere of Authority

• Ensures the CMC development and commercial product regulatory strategy meets global regulatory requirements over the lifecycle of the product and is in alignment with the strategies of global regulatory affairs, the therapeutic area, commercial, regional functions and the Quality Target Product Profile (QTPP)
• Assures connectivity to the overall global regulatory strategy through partnership and communication with Therapeutic Area Regulatory Affairs (Global Regulatory Leader).

• Refines regulatory strategies as new data become available.

• Escalates issues to CMC Regulatory Affairs Management that affect registration, regulatory compliance and continued lifecycle management of the product.
• Develops and updates contingency plans for issues that may affect registration, regulatory compliance and the continued lifecycle management of the products in scope.
• Effectively and tactfully communicates with health authorities; maintain good relationship and credibility.
• Reviews CMC regulatory dossiers for global submissions throughout the product lifecycle.
• Provides accurate regulatory assessments of CMC changes and executes regulatory planning and implementation.

Position Requirements

• BS in biological, pharmaceutical, chemical or engineering sciences with generally a minimum of 8+ years of experience inclusive of post graduate education and/or pharmaceutical or health care industry experience or equivalent. An MS, Ph.D., or Pharm. D. degree preferred

• Demonstrated ability to communicate regulatory requirements.

• Solid understanding of biology, chemistry and/or engineering relevant to pharmaceutical industry

• Experience developing regulatory strategies and an understanding of product development, seen as an expert on product development and how it is applied in global regulatory strategy.

• Strong attention to detail with high-level verbal and written communication skills

• Communicates cross-functionally and cross-company. Presents and defends CMC management-approved regulatory strategy and opinion to project teams.

• Demonstrates model behavior that understands what the priorities are and encourages others to drive for results

• Experience interacting with Health Authorities under supervision of a senior member of the CMC RA staff.
• Good knowledge of global HA laws, regulations, guidance and regulation submission routes available for assigned products.
• Some understanding of competitors in the area and what they are doing in early/late development

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
• 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
• service anniversary and recognition awards
• subject to the terms of their respective plans, employees - and in some location’s eligible dependents - can participate in several insurance plans

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

The anticipated base pay range for this position is:

zł205,000.00 - zł354,200.00