Associate Director, CMC Regulatory Affairs

Associate Director, CMC Regulatory Affairs - ~~~W

Description

Johnson & Johnson is recruiting for an Associate Director, CMC Regulatory Affairs. This position can be located in Spring House, PA; Horsham, PA; Titusville, NJ; Raritan, NJ; Beerse, Belgium or Leiden, Netherlands. Remote work options may be considered on a case-by-case basis and if approved by the Company.

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions 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 ~~~/.

For more than 130 years, diversity, equity & inclusion (DEI) has been a part of our cultural fabric at Johnson & Johnson and woven into how we do business every day. Rooted in Our Credo, the values of DEI fuel our pursuit to create a healthier, more equitable world. Our diverse workforce and culture of belonging accelerate innovation to solve the world's most pressing healthcare challenges.

We know that the success of our business - and our ability to deliver meaningful solutions - depends on how well we understand and meet the diverse needs of the communities we serve. Which is why we foster a culture of inclusion and belonging where all perspectives, abilities and experiences are valued and our people can reach their potential.

At Johnson & Johnson, we all belong.

Johnson & Johnson is looking for an individual with expertise in parenteral and general pharmaceutical development to guide the CMC and regulatory aspects of development and commercialization. This person is responsible for developing global CMC regulatory strategies. The primary responsibility is to work on CMC regulatory activities related to but not limited to parenterals. The role involves working in product development and post marketing applications in global markets. The individual will support CMC teams and provide input on the interpretation and application of global CMC regulations and strategic guidance. The ideal candidate will have knowledge about the country specific requirements needed to support IND/IMPD during clinical development as well as during marketing applications globally.

Key Responsibilities:

• Provides guidance and expertise to the Global Regulatory Team to develop global submission plans that comply with local regulatory requirements and commitments.

• Develops and executes CMC regulatory strategies that support the development of the products in which the candidate is responsible for.

• Provides regulatory and technical expertise and input to the CMC team to facilitate successful product development globally

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

• Provides technical expertise and technical input in the preparation and writing (as applicable) of regulatory dossiers for submission to Health Authorities globally.

• Has experience with writing/ reviewing briefing books & responding to questions from the Health Authorities.

• Has participated in Health Authority meetings and has experience in drafting questions and company position for the Health Authorities.

• Assesses manufacturing changes and evaluates the impact on marketing applications.

• Works closely with supply chain to ensure continuity of product

• May lead selected initiatives within the department

• Participates in and conducts due diligence/licensing evaluations as needed

• 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

• 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; maintains good rapport and credibility. When appropriate leads meetings with Health Authorities under supervision of a senior member of the department.

• Reviews CMC regulatory dossiers for global submissions throughout the product lifecycle

• Provides accurate regulatory assessments of chemistry, manufacturing and control changes to teams/projects and executes regulatory planning and implementation.

Qualifications

Education:

• Minimum of Bachelor's degree in biological, pharmaceutical, chemical or engineering sciences with generally a minimum of 10 years of experience inclusive of post graduate education and/or pharmaceutical or health care industry experience or equivalent is required. An MS, Ph.D., or Pharm. D. degree preferred

Experience and Skills:

• Demonstrated ability to communicate regulatory requirements.

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

• 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 leading interactions with Health Authorities under supervision of a senior member of the CMC RA staff.

• Strong knowledge of global HA laws, regulations, guidance and regulation submission routes available for assigned products.

• Good understanding of competitors in the area and what they are doing in early/late development

The anticipated base pay range for this position is $135,000 to $232,300.

Company maintains highly competitive, performance-based compensation programs. Under current guidelines, this position is eligible for an annual performance bonus in accordance with the terms of the applicable plan. The annual performance bonus is a cash bonus intended to provide an incentive to achieve annual targeted results by rewarding for individual and the corporation's performance over a calendar/performance year.

Bonuses are awarded at the Company's discretion on an individual basis.

• Employees and/or eligible dependents may be eligible to participate in the following Company sponsored employee benefit programs: medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance.

• Employees may be eligible to participate in the Company's consolidated retirement plan (pension) and savings plan (401(k)).

• This position is eligible to participate in the Company's long-term incentive program.

• Employees are eligible for the following time off benefits:

• Vacation - up to 120 hours per calendar year

• Sick time - up to 40 hours per calendar year; for employees who reside in the State of Washington - up to 56 hours per calendar year

• Holiday pay, including Floating Holidays - up to 13 days per calendar year of Work, Personal and Family Time - up to 40 hours per calendar year

• Additional information can be found through the link below. ~~~

The compensation and benefits information set forth in this posting applies to candidates hired in the United States. Candidates hired outside the United States will be eligible for compensation and benefits in accordance with their local market."

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.

For more information on how we support the whole health of our employees throughout their wellness, career and life journey, please visit ~~~.

Primary Location NA-US-Pennsylvania-Horsham

Other Locations NA-United States, NA-US-Pennsylvania-Spring House, Europe/Middle East/Africa-Netherlands-South Holland-Leiden, Europe/Middle East/Africa-Belgium-Antwerp-Beerse, NA-US-New Jersey-Raritan, NA-US-New Jersey-Titusville

Organization Janssen Research & Development, LLC (6084)

Job Function Regulatory Science

Req ID: ~~~W