Regulatory Affairs Senior Associate

Janssen Research & Development, L.L.C., a member of Johnson & Johnson’s Family of Companies, is recruiting for a Senior Associate, Global Regulatory Affairs. The position will focus on drug products and will be based at one of the following sites: United States: New Jersey - Titusville, Raritan, and other J&J locations on the East Coast; other locations include High Wycombe, UK, Leiden, Netherlands, Beerse, Belgium and Warsaw, Poland. Remote work options may be considered on a case-by-case basis and if approved by the Company.

Janssen thrives on a diverse company culture, celebrating the uniqueness of our employees and is committed to inclusion. Janssen is proud to be an equal opportunity employer. Our culture is interconnected by the shared values of Our Credo. It is a culture that celebrates diversity and diverse perspectives, and helps its employees achieve an effective balance between work and home life and supports their efforts to have a positive impact on their communities.

As a Senior Associate, you will provide regulatory support to the Regional Regulatory Liaison and/or Global Regulatory Leader for a portfolio of CNS drug products which are supported by the Established Products team. This includes:

- Contributing to the regulatory activities for products that are currently marketed and ensuring that all regulatory filings support the global regulatory strategy.
- Ensuring compliance and adherence to all post-approval requirements.
- Supporting the regulatory strategy and activities for products that may have additional post-approval development activity.
- Supporting the regulatory activities and strategy to register products in line with agreed regulatory submission and approval targets.

**Key Responsibilities of this role include**:

- Act as a liaison with internal (e.g. labeling, supply chain, commercial, legal, clinical and medical affairs) and external stakeholders (e.g. business partners) to ensure that submissions and responses to Health Authority queries are made in a timely manner.
- Review dossier content to ensure compliance with regulatory strategy.
- Assist in the completion of periodic safety reports, annual reports, and renewals and to interact with external third parties as required for the completion of these reports.
- Where applicable, participate in development and clinical trial activities.
- Contribute to delisting and divestment activities and, where applicable, litigation support.
- Provide regulatory input for and appropriate follow-up to inspections and audits.
- Serve as the Regulatory representative on specific multi-discipline teams

**Qualifications**
**Qualifications**:

- A minimum of a Bachelor’s Degree/undergraduate in a scientific or technical discipline is required plus at least 3 years relevant regulatory/industry experience.
- Experience in a regulatory affairs or related function (e.g., R&D, quality, regulatory compliance) is required.
- HA regulatory knowledge in any one of the following regions - US /EU / LATAM / AsiaPac is an asset.
- HA regulatory knowledge of US Regulations (21 CFR) and/or EU Regulations is an asset.
- Understanding of the drug development process is preferred.
- Understanding of the regulatory submission and approval process is required.
- Experience developing sections/modules for pre
- or post-approval regulatory submissions for drug products is preferred.
- Knowledge of risk management principles is preferred.
- Direct experience in regulatory affairs is desirable.
- The ability to work successfully within a collaborative, cross-functional, matrix team environment, as well as individually, is required.
- The ability to prioritize effectively for multiple products and/or projects is required.
- The ability to up to 10% travel is required.

Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.

**Primary Location**
United Kingdom-England-High Wycombe
- **Other Locations**
North America-United States-New Jersey-Titusville, Europe/Middle East/Africa-Netherlands-South Holland-Leiden, Europe/Middle East/Africa-Poland-Mazowieckie-Warsaw, North America-United States-New Jersey-Raritan, Europe/Middle East/Africa-Belgium-Antwerp-Beerse
**Organization**
Janssen Cilag Ltd. (7360)
**Job Function**
Regulatory Affairs
**Requisition ID**
2206021984W