Director Product Regulatory Affairs &#8211; Pharma (Remote US) in Allentown, Pennsylvania
As a leader in the science of nutrition, Nestlé Health Science believes in empowering healthier lives for patients and consumers through a rich product portfolio featuring top brands such as Garden of Life®, Nature’s Bounty®, Vital Proteins®, Nuun®, Persona Nutrition®, BOOST®, Carnation Breakfast Essentials®, Peptamen®, Compleat Organic Blends®, and more, as well as through Aimmune Therapeutics, a biopharmaceutical company developing therapies to prevent, manage and treat food, GI and metabolic-related diseases.
Our team members are challenged to make a genuine impact and play an integral role in driving the business forward. We embrace a dynamic culture that always puts the consumer first, and where ownership, accountability and agility are celebrated at every level. To help our people thrive, we offer expansive career growth potential, the opportunity to work alongside and learn from talented colleagues with diverse backgrounds and skill sets, and a range of best-in-class benefits.
We have more than 11,000 employees around the world, and products available in over 140 countries.
This position is not eligible for Visa Sponsorship.
The Director, Global Regulatory Affairs will be a strategic leader providing direction and managing regulatory activities associated with commercial and growing pipeline of clinical development projects/programs in food allergy, gastro-intestinal, rare disease, and other therapeutic areas. The primary responsibilities for this position include planning, coordination, and assembly of key regulatory documents for review and submission to health authorities (i.e., FDA, MHRA, Health Canada, and other regulatory agencies, as needed). The candidate will have demonstrated the ability to work independently, apply knowledge of regulatory requirements (specific to key regions such as the US, EU, Canada, and other EU countries) to their daily work and manage critical projects as part of an interdisciplinary team. The Director, Regulatory Affairs is responsible for managing, tracking, and maintaining submission to health authorities (e.g., Orphan indications, IND, BLA, and MAA) and establishing good working relationships with regulatory authorities.
The primary job functions include, but not limited to the following:
Independently develop regulatory dossiers/documents to support programs in a rare disease indication, provide ongoing regulatory strategy and support to FDA requests regarding company’s request for Orphan Drug Designations.
Maintain FDA and European Medicines Agency (EMA) orphan drug designations by submitting Orphan Drug Annual Reports and other submissions as required; provide ongoing regulatory strategy and support.
Compile, review, and submit documents for the company, including but not limited to initial Pre-INDs, INDs/CTAs/BLAs and amendments or supplements.
Assist regulatory management and project teams in the development and implementation of regulatory strategies and plans.
Work cross-functionally and collaboratively with leadership from manufacturing, supply chain, quality assurance, and project management to ensure timely availability stability data and reports studies.
Develop, maintain, and communicate timelines for regulatory submissions to ensure timely delivery of regulatory documentation.
Participate in the review of critical documents such as: protocols, ICFs, IBs, CSRs, DSURs, etc. to ensure they are compliant with relevant regulations and guidance (e.g. ICH, FDA, EMA, etc.) prior to submission.
Coordinate with Regulatory Operations to appropriately plan and finalize submissions to health authorities in accordance with regulations and guidelines.
Maintain databases of regulatory information, submissions, and correspondence.
Independently plan daily work to complete time sensitive assignments.
Review, write and present guidelines and SOPs as needed to support high quality submissions and assure adherence to regulatory requirements.
Maintain current knowledge of applicable US and global regulations, guidance, and standards for drug development and product registration.
Qualifications / Requirements:
A minimum of a BS in life sciences with 10-12 years of experience in Regulatory Affairs roles.
Demonstrated experience leading eCTD formatted submissions for biologics and/or drugs e.g. INDs, NDAs/BLAs, MAAs, annual reports, amendments and supplements.
Previous experience with NDA or BLA submissions desirable.
Experience in management of all components of regulatory submissions including chemistry, manufacturing & controls (CMC), annual reports, lot distribution reports and drug listing activities to maintain commercial products.
Detailed understanding of the drug development process, FDA/EMA guidance and regulations, and knowledge of global guidance.
Has successfully coordinated and supported responses to health authorities and critical submission projects while maintaining agreed timelines.
High attention to detail, ability to work on multiple projects with tight deadlines and able to work independently.
Demonstrates creative approach to problem solving; with a demonstrated track record of being results driven.
Special Skills / Knowledge:
Excellent oral and written communication skills and time management skills essential.
Demonstrated ability to work effectively with and/or lead cross-functional teams e.g., research, clinical, and CMC teams.
Ability to develop regulatory plans and strategies while proactively identifying risks.
Ability to work on multiple tasks to meet company objectives.
Strong attention to detail.
Knowledge of 21 CFR and FDA, ICH, GCP, GMP, and global guidelines.
Excellent Computer Skills – MS Word, Excel, Power Point, and document management software/system.
It is our business imperative to remain a very inclusive workplace.
To our veterans and separated service members, you’re at the forefront of our minds as we recruit top talent to join Nestlé. The skills you’ve gained while serving our country, such as flexibility, agility, and leadership, are much like the skills that will make you successful in this role. In addition, with our commitment to an inclusive work environment, we recognize the exceptional engagement and innovation displayed by individuals with disabilities. Nestlé seeks such skilled and qualified individuals to share our mission where you’ll join a cohort of others who have chosen to call Nestlé home.
The Nestlé Companies are an equal employment opportunity and affirmative action employer seeking diversity in qualified applicants for employment. All applicants will receive consideration for employment without regard to race, ethnicity, color, gender, gender identity, age, religion, national origin, ancestry, disability, perceived disability, medical condition, genetic information, veteran status, sexual orientation, or any other protected status, as defined by applicable law. Prior to the next step in the recruiting process, we welcome you to inform us confidentially if you may require any special accommodations in order to participate fully in our recruitment experience. Contact us at [email protected] or please dial 711 and provide this number to the operator: 1-800-321-6467.
This position is not eligible for Visa Sponsorship.
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