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Job ID

393814BR

About the role

Sandoz is going through an exciting and transformative period as a global leader and pioneering provider of sustainable Generic and Biosimilar medicines.

Now as an independently listed company, Sandoz aims to increase its strategic focus, operate with greater agility, set clearer business objectives, enhance shareholder returns, and strengthen its culture for us, the Sandoz associates. This is an exciting time in our history, and by creating a new and ambitious path, it will provide a unique opportunity for us all, both professionally and personally.

Join us as a Founder of our ‘new’ Sandoz!

As the Associate Director/Director of Regulatory Affairs, you will direct a team within Regulatory in the development of submissions for New Drug and Abbreviated New Drug Applications for generic medicines. The level of the position will be commensurate with experience. This role will work directly with the development and maintenance teams on the product registrations, through FDA communication and review process, amendments, supplements, and annual reports. You will provide strategic product direction to cross functional teams with regards to Regulatory requirements and negotiate evidence with regulatory agencies. Interact and negotiate with regulatory agency personnel to expedite approval of pending registrations and answer any FDA related questions. Serves as a regulatory liaison on the project team from development throughout the product lifecycle. Ensures rapid and timely approval of new drugs, abbreviated new drugs and continued maintenance activities of marketed drugs. Serves as regulatory representative to marketing or research project teams and government regulatory agencies. Provides advice to development and/or manufacturing sites on manufacturing changes, line extensions, technical labeling, appropriate regulations and interpretations. Coordinates, reviews, and may prepare submissions.

Additional responsibilities include, but not limited to:

  • Preparation of regulatory new drug submissions (ANDA/NDAs), amendments, supplements, and annual report submissions.
  • Effectively manage a team of regulatory associates to handle a dedicated portfolio from beginning to end
  • Properly and compliantly evaluate proposed changes and provide regulatory input as needed for the US market
  • Effectively manage submission preparation to ensure implementation dates and approval goal dates are met.
  • Contribute to performance and KPI´s of the team to deliver agreed upon targets and objectives and supports reporting.
  • Provide internal and external development and maintenance sites, business development partners, and manufacturing business partners with proper strategic alignment and change evaluations to plan and implement registration activities and to meet commitments and requests from FDA including deficiency letters.
  • Ensure that the escalation process to next or higher-level management is followed.
  • Provide regulatory consultancy for products and technical operations.
  • Ensure proper data management.

This opportunity is located at the Sandoz Princeton, NJ site. Sandoz follows a hybrid approach to work location.

Preference will be given to local candidates not requiring relocation.

The pay range for this position at commencement of employment is expected to be between $174,400 and $261,600/year for an Associate Director level and $201,600 and $302,400 for Director level; however, while salary ranges are effective from 1/1/24 through 12/31/24, fluctuations in the job market may necessitate adjustments to pay ranges during this period. Further, final pay determinations will depend on various factors, including, but not limited to geographical location, experience level, knowledge, skills and abilities. The total compensation package for this position may also include other elements, including a sign-on bonus, restricted stock units, and discretionary awards in addition to a full range of medical, financial, and/or other benefits (including 401(k) eligibility and various paid time off benefits, such as vacation, sick time, and parental leave), dependent on the position offered. Details of participation in these benefit plans will be provided if an employee receives an offer of employment. If hired, employee will be in an “at-will position” and the Company reserves the right to modify base salary (as well as any other discretionary payment or compensation program) at any time, including for reasons related to individual performance, Company or individual department/team performance, and market factors.

On September 30, 2021, Sandoz entered into a 5-year Corporate Integrity Agreement. Certain positions will have responsibilities to support the execution and adherence to CIA obligations, CIA-related deliverables, and any relevant audit, monitoring or Independent Review Organization (IRO) remediation.

Position Title

Associate Director / Director, Regulatory Affairs (Generic Medicines)

Role Requirements

What you'll bring to the role:

  • Requires recent experience within Regulatory Affairs focusing on generic medicines
  • Minimum of a Bachelor’s degree is required. An MS, PhD, or PharmD degree is highly preferred
  • Associate Director level requires a minimum of 7 years of pharmaceutical related experience including a minimum of 5 years of Regulatory Affairs experience with a primary focus on generic medicines
  • Director level requires a minimum of 10 years of pharmaceutical related experience, including a minimum of 8 years of Regulatory Affairs experience with a primary focus on generic medicines. The level of the position will be commensurate with experience.
  • Requires recent hands-on experience with CMC documentation and strategy for generic medicines

Why Sandoz?

Generic and Biosimilar medicines are the backbone of the global medicines industry. Sandoz, a leader in this sector, touched the lives of almost 500 million patients last year and while we are proud of this achievement, we have an ambition to do more!

With investments in new development capabilities, state-of-the-art production sites, new acquisitions, and partnerships, we have the opportunity to shape the future of Sandoz and help more patients gain access to low-cost, high-quality medicines, sustainably.

Our momentum and entrepreneurial spirit is powered by an open, collaborative culture driven by our talented and ambitious colleagues, who, in return for applying their skills experience an agile and collegiate environment with impactful, flexible-hybrid careers, where diversity is welcomed and where personal growth is encouraged!

The future is ours to shape!

At Sandoz we offer a hybrid approach to work, along with a comprehensive benefits package and generous PTO. Just a few reasons to join us on our journey!

Join our Sandoz Network: If this role is not suitable to your experience or career goals but you wish to stay connected to hear more about Sandoz and our career opportunities, join the Network here: https://talentnetwork.novartis.com/sandoztalentpool

#Sandoz

Job Type

Full Time

Country

USA

Work Location

Princeton, NJ

Functional Area

Research & Development

Division

SANDOZ

Business Unit

NON-NVS TSA COMMERCIAL OPS NA SZ

Employment Type

Regular

Company/Legal Entity

Sandoz Inc

Commitment to Diversity & Inclusion:

We are Equal Opportunity Employers and take pride in maintaining a diverse environment. We do not discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, marital or veteran status, disability, or any other legally protected status. We are committed to building diverse teams, representative of the patients and communities we serve, and we strive to create an inclusive workplace that cultivates bold innovation through collaboration and empowers our people to unleash their full potential.

Accessibility and Reasonable Accommodations: Individuals in need of a reasonable accommodation due to a medical condition or disability for any part of the application process, or to perform the essential functions of a position, please let us know the nature of your request, your contact information and the job requisition number in your message:

  • Novartis: e-mail us.reasonableaccommodations@novartis.com or call +1 (877)395-2339
  • Sandoz: e-mail reasonable.accommodations@sandoz.com or call: +1-609-422-4098

Shift Work

No

Early Talent

No

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Confirmed 21 minutes ago. Posted 21 days ago.

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