Regulatory Affairs Assoc III

Teva; West Chester (Chester County); On-site; USD 65,000 - 90,000; Full time

Benefits offered by this job

Health insurance

401(k) with employer match

Paid time off

Life and disability insurance

Employee assistance program

Job summary

Teva seeks an Associate III, PARC Operations, to manage materials through Teva’s PARC review process. You will route materials, schedule PARC meetings, and ensure timely completion of all required activities before PARC discussions.

Ideal candidates have 4–6 years of experience in prescription drug advertising review, Veeva proficiency, and knowledge of FDA 2253 submissions. strong organization and teamwork are essential.

Qualifications

• 4–6 years of experience with review and approval of prescription drug advertising and promotion materials.
• Experience with electronic review systems for advertising and promotion (Veeva) preferred.
• Working knowledge of FDA 2253 submission process in eCTD format.
• Excellent organization and follow-up skills.
• Ability to work independently within the PARC structure and with outside Agencies.

Responsibilities

• Route review materials to PARC team members within timelines.
• Schedule and manage PARC meeting dates/times and issue agendas timely.
• Ensure all activities leading up to PARC meetings are completed on time.
• Ensure PARC comments are addressed and understood by participants.
• Document final changes to materials and outcomes of PARC discussions.
• Review and approve material proofs ensuring PARC changes are incorporated.
• Prepare and manage submissions to FDA OPDP within timelines.
• Collaborate with responsible functions to manage material expiry/renewals.
• Author and review PARC process and internal guidance documents.
• Develop and run reports to support metrics and document compliance.

Skills

PARC process experience

Veeva experience

Organizational skills

Independent worker

Education

BA/BS Degree

Tools

Veeva

FDA 2253 eCTD

Job description

We Are Teva

We’re Teva, a leading innovative biopharmaceutical company, enabled by a world-class generics business. Whether it’s innovating in the fields of neuroscience and immunology or delivering high-quality medicine worldwide, we’re dedicated to addressing patients’ needs now and in the future. Here, you will be part of a high-performing, inclusive culture that values fresh thinking and collaboration. You'll have the room to grow, the flexibility to balance life with work, and the opportunity to better health worldwide, together.

Our Team, Your Impact

The Associate III, PARC Operations, is responsible for managing materials through Teva’s Promotion and Advertising Review Committee (PARC) process. The PARC process supports the review/approval of all product advertising and promotional materials, as well as other related materials, (e.g., disease awareness campaigns, sales training materials, etc.) to assure adherence to established regulatory requirements, corporate standards and procedures prior to use.

How You’ll Spend Your Day

• Route review materials to assigned PARC team members within established timelines.
• Schedule and manage PARC meeting dates/times and issue PARC agendas in a timely manner.
• Assure that all required activities leading up to PARC meetings are successfully completed within established timelines.
• Assure that all PARC review team comments are addressed and understood by PARC participants.
• Document any final changes to the materials and any outcomes of PARC discussions and route materials for final disposition.
• Review and approve material proofs to ensure that all PARC requested changes have been properly incorporated.
• Prepare and manage submissions to the US Food and Drug Administration Office of Prescription Drug Promotion (FDA OPDP) within established timelines.
• Proactively work with the responsible functions to assure that materials are expired or renewed in accordance with established procedures and timelines.
• Author and review PARC related process and internal guidance documents
• Develop and run reports to support metrics and document compliance

Your Skills and Experience

Required Qualifications:

• 4-6 years of experience with processes related to the review and approval of prescription drug advertising and promotion materials.
• Working knowledge of at least one electronic review system designed for advertising and promotion materials (Veeva) preferred.
• Working knowledge of the FDA 2253 submission process in eCTD format
• Demonstrates excellent organization and follow up skills
• Ability to work independently within the PARC structure and with outside Agencies

Also Good to Have

Preferred Qualifications:

• BA/BS Degree.
• Ability to work under pressure and adhere to deadlines.
• Ability to work well in teams, including but not limited to peers and PARC members.
• Excellent written and verbal communication skills.

How We’ll Take Care of You

We offer a competitive benefits package, including:

• Comprehensive Health Insurance: Medical, Dental, Vision, and Prescription coverage starting on the first day of employment, providing the employee enrolls.
• Retirement Savings: 401(k) with employer match, up to 6% and an annual 3.75% Defined Contribution to the 401k plan.
• Time Off: Paid Time Off including vacation, sick/safe time, caretaker time and holidays.
• Life and Disability Protection: Company paid Life and Disability insurance.
• Additional benefits include, but are not limited to, Employee Assistance Program, Employee Stock Purchase Plan, Tuition Assistance, Flexible Spending Accounts, Health Savings Account, Life Style Spending Account, Volunteer Time Off, Paid Parental Leave, if eligible , Family Building Benefits, Virtual Physical Therapy, Accident, Critical Illness and Hospital Indemnity Insurances, Identity Theft Protection, Legal Plan, Voluntary Life Insurance and Long Term Disability and more.

The total compensation may also include restricted stock units and discretionary awards, depending on the position offered. Details of participation in these benefit plans will be provided if an employee receives an offer of employment.

Teva’s Equal Employment Opportunity Commitment

Teva Pharmaceuticals is committed to equal opportunity in employment. It is Teva's policy that equal employment opportunity be provided without regard to age, race, creed, color, religion, sex, disability, pregnancy, medical condition, genetic information, marital status, sexual orientation, gender identity or expression, ancestry, national or ethnic origin, citizenship status, military status or status as a disabled or protected veteran, or any legally recognized status entitled to protection under applicable federal, state, or local laws.

Please advise us of any accommodations needed to support you throughout the recruitment and selection process. All accommodation information provided will be treated as confidential and used only for the purpose of providing an accessible candidate experience. Request a reasonable accommodation by sending an email to [e-mail] with the nature of your request and your contact information. Only inquiries concerning a request for a reasonable accommodation will be responded to from this email address.