Associate Director Regulatory Affairs
Job Description 500 million patients were touched by Sandoz generic and biosimilar medicines in 2020 and while we're proud of this, we know there is more we could do to continue to help pioneer access to medicines for people around the world.
Directs the development of submission of product registration, progress reports,supplements, amendments, and/or periodic experience reports. Provides strategic product direction to teams on interaction and negotiates evidence with regulatory agencies.Interacts and negotiates with regulatory agency personnel in order to expedite approval of pending registration and answers any questions. Serves as a regulatory liaison on the project team throughout the product lifecycle. Ensures rapid and timely approval on of new drugs, biologics/biotechnology and/or medical devices and continued approved status of marketed drugs or medical devices. Serves as regulatory representative to marketing or research project teams and government regulatory agencies. Provides advice to development and/or marketing teams on manufacturing changes, line extensions, technical labeling, appropriate regulations and interpretations. Coordinates, reviews, and may prepare reports for submission.
* Is responsible for implementing regulatory strategy and managing operational activities for assigned major/ large regions.
* Provides input into global regulatory strategy and contributes to Regulatory Functional
* Plan (RFP) and Seed Document, or their equivalents, including identification of gaps or risks in global strategic plan for assigned regions.
* Partners with regions to align on regulatory strategy in order to fulfil business objectives
* Implements RFP across assigned regions.
* Determines requirements and sets objectives for Health Authority (HA) interactions with DRA GPT representative and/or GTAL.
* Facilitates preparation and finalization of briefing books and contributes to preparation of summary documents.
* Develops and implements plans for timely response to HA requests and coordinates responses.
* May lead negotiations for regional approvals independently or with DRA GPT representative and/or GTAL.
* Responsible for facilitating timely submission and approval of dossier with HAs under the guidance of the DRA GPT representative and/or GTAL.
* Contributes to and often leads the development of departmental goals and objectives.
The pay range for this position at commencement of employment is expected to be between $158,400 and $237,600 year; however, while salary ranges are effective from 1/1/23 through 12/31/23, 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. EEO Statement The Novartis Group of Companies 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. Minimum requirements PhD, PharmD or BS in Science major. Advanced degree is preferred.
* 7+ years of pharmaceutical and/or biotech development related experience including a minimum of 5 years of regulatory affairs strategy experience, preferably biologics experience.
Why Sandoz?
How will we do this? We believe new insights, perspectives and ground-breaking solutions can be found at the intersection of medical science and digital innovation. That a diverse, equitable and inclusive environment inspires new ways of working.
We believe our potential can thrive and grow in an unbossed culture underpinned by integrity, curiosity and flexibility. And we can reinvent what's possible, when we collaborate with courage to aggressively and ambitiously tackle the world's toughest medical challenges. Because the greatest risk in life, is the risk of never trying!
Imagine what you could do here at Sandoz! Business Unit COMMERCIAL OPS NA SZ Work Location Princeton, NJ Company/Legal Entity Sandoz Inc Functional Area Research & Development
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Novartis Group Companies
parental leave, paid time off, sick time, 401(k)
Sep 05, 2023