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Senior Regulatory Affairs Program Lead - 2206073858W

Description

With annual sales of $11 billion, the Global Surgery Group is the world’s largest, most innovative surgical company. The strength of the Global Surgery Group is illustrated by the fact that more than 80% of our sales come from businesses with #1 or #2 global market share positions. We serve customers around the world, with about 60% of our sales generated outside the U.S., including a fast-growing presence in emerging markets. The Global Surgery Group is committed to innovation, with about 30% of our sales coming from products introduced in the past five years.

The Ethicon Surgical Care business offers a broad range of products, platforms and technologies—including sutures, surgical staplers, clip appliers, trocars and synthetic mesh devices—that are used in a wide variety of minimally invasive and open surgical procedures. Specialties include support for treatment of colorectal and thoracic conditions, women’s health conditions, hernias, cancer and obesity. The Ethicon Surgical Care business combines products and services of two market-leading legacy companies, both with long histories of medical innovation. Ethicon, Inc. based in Raritan, New Jersey, was founded more than 80 years ago as a pioneer in suture development and manufacturing, helping to transform the safety and effectiveness of open surgery. Ethicon Endo-Surgery, Inc. was created 20 years ago in Cincinnati, Ohio, developing innovative devices that have driven the revolutionary shift from open to minimally invasive surgery that continues to lead the industry today.

Ethicon Biosurgery, a member of Johnson & Johnson's Global Surgery Organization, is recruiting for a Sr. Program Lead, Regulatory Affairs , to be located in the U.S. (Raritan, NJ), Israel (Ness Ziona), or Europe . Other locations will be considered.

Position Duties

The Sr. Program Lead, Regulatory Affairs will be a member of the Ethicon Biosurgery Regulatory team and will be responsible for managing the Biologic regulatory strategies and submissions (BLA supplements, MAA variations, CTA and IND submissions and amendments, etc.) to support New Product Development, clinical studies, post-marketing safety requirements and submissions, and lifecycle maintenance related to the biological/combination products within the Ethicon Biosurgery platform. This role may also have some responsibility for medical device regulatory submissions and post-market responsibilities as well as liaising with J&J affiliates to support global regulatory submissions.

Roles Duties

• Prepare U.S. FDA, EMA, and international submissions for clinical, pharmacovigilance, and labelling changes related to biologics/combination products and/or medical devices as required, to ensure timely approval for market release. Communicate directly with cross-functional project team members, international Regulatory affiliates, and Health Authorities.

• Support all regulatory activities associated with the development, post-approval and life-cycle management for biologic/combination and/or medical device products. Support the creation of regulatory documents by interacting with project teams, Local Operating Companies (LOCs) in various global markets, and regulatory agencies and supporting submissions as appropriate.

• Develop and execute regulatory strategies/plans that comply with global regulatory requirements.

• Provide ongoing support to product development teams for regulatory issues/questions.

• Provide regulatory consultation/advice to cross-functional team members and leadership including Marketing, Medical, Clinical, Research and Development, Pharmacovigilance, and other functions as needed with regard to promotional and scientific materials, labelling and other commercial-related activities to support Ethicon Biosurgery products.

• Supporting the Advertising and Promotional Regulatory review of promotional and scientific materials within assigned product lines, as needed.

• Support the Pharmacovigilance team with interpretation of regulations and guidance, as well as process support, as needed.

• Support internal audits and external inspections by regulatory agencies as required.

• Contribute to the definition and development of new processes, procedures, standards or operational plans in support of the organizational/ business strategies, with a direct impact on business unit/function overall results.

• Provides mentorship to more junior level staff and contractors. May manage more junior team members.

• Ensure Regulatory Affairs files are maintained to support compliance with regulatory requirements.

Competencies

• Works independently in a role that demonstrates organizational influence within or across RA sub-functions and related functions. Transforms concepts into executable initiatives, and drives definition of project scope, timelines and deliverables. Seeks input from and forges agreements among sponsors regarding initiative goals and objectives.

• Leads project teams effectively. Escalates and drives resolution of project issues. Demonstrates effective group facilitation skills and ability to drive consensus among team members regarding process changes.

• Strong verbal and written communication skills.

• Ability to work effectively with diverse and global audiences and personnel.

• Ability to interact with senior management executives.

• Ability to work collaboratively in a matrix environment, building local and global partnerships is required.

• Strong attention to detail and problem-solving skills.

• Effective time management skills.

Qualifications

Qualifications

• B.S. in a life-science and/or technical field is required (pharmacy, chemistry, biology, engineering, etc); Advanced degree preferred.

• Minimum of 4-6 years of experience in regulated industry, preferred Regulatory Affairs or Clinical Affairs experience with a proven track record of involvement in US and EU regulatory submissions of biologic, pharmaceutical and/or combination products.

• Experience with US, EU and other local regulatory agencies for clinical trial study data generation for use in regulatory submissions is preferred.

• Combination product experience is preferred. Medical device experience is a plus.

• Strong project management skills required.

This position may be located in either the U.S. (Raritan, NJ), Israel (Ness Ziona), or Europe. Other locations will be considered. Up to proximately 10% travel may be required (US, Europe, Israel).

At Johnson & Johnson, we’re on a mission to change the trajectory of health for humanity. That starts by creating the world’s healthiest workforce. Through cutting-edge programs and policies, we empower the physical, mental, emotional, and financial health of our employees and the ones they love. As such, candidates offered employment must show proof of COVID-19 vaccination or secure an approved accommodation prior to the commencement of employment to support the well-being of our employees, their families and the communities in which we live and work.

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

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 NA-US-New Jersey-Raritan

Other Locations Europe/Middle East/Africa-United Kingdom, Europe/Middle East/Africa-Sweden, Europe/Middle East/Africa-Netherlands, Europe/Middle East/Africa-Ireland, Europe/Middle East/Africa-Israel, Europe/Middle East/Africa-Germany, Europe/Middle East/Africa-France, Europe/Middle East/Africa-Belgium, Europe/Middle East/Africa-Denmark

Organization Ethicon Inc. (6045)

Job Function Regulatory Affairs

Req ID: 2206073858W