Sr Scientist Product Lead CMC RA

Biopharma Careers; Beerse; Sur place; EUR 73 000 - 115 000; Plein temps

Avantages offerts par ce poste

Annual bonus

Vacation days

Parental leave

Bereavement leave

Caregiver leave

Volunteer leave

Well-being reimbursement

Insurance plans

Résumé du poste

Johnson & Johnson Beerse (Belgium), Warsaw (Poland) or East Coast USA seeks a Senior Scientist Product Lead CMC RA - Synthetics, New Modalities to drive regulatory strategy for global CMC programs.

You will contribute to global CMC regulatory strategies, lead on CMC Teams, prepare dossiers for Health Authorities, and ensure compliance with regulatory requirements while collaborating across functions and regions.

Qualifications

• Bachelor's degree in biological, pharmaceutical, chemical or engineering sciences; MS/PhD preferred.
• Demonstrated ability to communicate regulatory requirements.
• Solid understanding of biology, chemistry or engineering relevant to pharmaceutical industry.
• Prior drug development, analytical development, or manufacturing experience.
• Strong attention to detail with high-level verbal and written communication skills.

Responsabilités

• Contributes to development of global CMC regulatory strategies and dossier plans.
• May participate as Regulatory CMC Lead on CMC Teams and provide regulatory expertise to facilitate global development.
• Supports global regulatory filings for development compounds and possibly marketed products.
• Prepares regulatory dossiers for submission to Health Authorities under supervision.
• Coordinates and manages CMC country-specific documents for global submissions.
• Assists in developing CMC Health Authority responses as needed.
• Drives continuous improvement to ensure compliance with Johnson & Johnson standards.

Connaissances

Regulatory communication

CMC regulatory

Drug development

HA interaction

Cross-functional collaboration

Attention to detail

Formation

Bachelor's degree in biological/pharmaceutical/chemical/engineering sciences

MS/PhD preferred

Description du poste

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 .

Job Function

Discovery & Pre-Clinical/Clinical Development

Job Sub Function

Regulatory Science

Job Category

Scientific/Technology

All Job Posting Locations

• Beerse, Antwerp, Belgium, Warsaw, Masovian, Poland
• East Coast USA - Requisition Number: R-098180

Job Description

About Innovative Medicine Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow.

Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way.

We are searching for the best talent for a Senior Scientist Product Lead CMC RA - Synthetics, New Modalities to be in our Beerse (Belgium), Warsaw (Poland) or our East coast USA locations.

Principle responsibilities

• Contributes to the development of global CMC regulatory strategies and dossier plans according to scientific/risk-based principles in collaboration with other Global CMC Regulatory Affairs (CMC RA) personnel.
• May participate as the Regulatory CMC Lead on CMC Teams and represent CMC RA by providing regulatory expertise on the CMC Core Team and Global Regulatory Team (GRT) to facilitate successful product development globally and to provide input on team recommendations.
• Supports global regulatory filings for mainly development compounds, and potentially also marketed products, in collaboration with other CMC RA senior personnel.
• Prepares regulatory dossiers for submission to Health Authorities under supervision.
• Coordinates, compiles, and manages CMC country specific documents required as part of the approval process for global submissions.
• Assists in developing and preparing CMC Health Authority responses as needed according to the proposed strategy.
• May participate in selected initiatives within CMC RA / GRA.
• Drives a culture of continuous improvement to ensure compliance with Johnson and Johnson standards, regulatory requirements and expectations. Communicates critical issues to Management.

Sphere of Authority

• May contribute to the development/implementation of global CMC regulatory strategies and dossier plans for development compounds (and marketed products).
• Ensures the CMC regulatory strategy 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) or other senior level CMC RA personnel.
• Provides input to and assists in the preparation of dossiers for submission to Health Authorities (NDA/BLA /MAA/IND/CTA and post approval variations).
• Assists in providing accurate regulatory assessments of CMC changes to teams for execution of regulatory planning and implementation.
• Escalates issues to CMC RA Management that affect registration, regulatory compliance and continued lifecycle management of the product.
• Assists in execution or development of contingency plans for issues that affect registration, regulatory compliance, and continued lifecycle management of the product.
• Provides CMC Regulatory support to health authority inspections.

Position Requirements

• BS in biological, pharmaceutical, chemical or engineering sciences with generally a minimum of 6+ 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.
• Prior drug development, analytical development, or manufacturing experience.
• 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.
• Working knowledge of global HA laws, regulations and guidances.

Benefits

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

€72,500.00 - €115,230.00

The anticipated pay ranges for additional locations are:

Poland – The anticipated base pay range for this position is 163.000 PLN/y– 262.200 PLN/y