Director, Scientific Regulatory Strategy and Scientific Writing

Are you a highly motivated and experienced regulatory strategist and scientific writer? Do you have a passion for promoting innovative healthcare solutions that can improve the lives of millions? If so, we have an exciting opportunity for you at Pfizer as our Director of Scientific Regulatory Strategy and Scientific Writing.In this role, you will lead a team of regulatory experts and scientific writers to develop and execute global regulatory strategies for our portfolio of pharmaceutical products. You will be responsible for ensuring compliance with regulatory requirements and providing strategic guidance to cross-functional teams. Additionally, you will oversee the development of high-quality scientific documents for regulatory submissions and internal communication.To be successful in this position, you must have a strong understanding of global regulatory requirements, excellent project management skills, and the ability to effectively communicate complex scientific information. A minimum of 10 years of experience in regulatory affairs and scientific writing in the pharmaceutical industry is required.If you are ready to make a meaningful impact in the healthcare industry and drive the success of life-changing medicines, join us at Pfizer as our Director of Scientific Regulatory Strategy and Scientific Writing.

1. Lead and manage a team of regulatory experts and scientific writers to develop and implement global regulatory strategies for Pfizer's portfolio of pharmaceutical products.
2. Ensure compliance with all relevant regulatory requirements and guidelines at the global level.
3. Provide strategic guidance and support to cross-functional teams in the development, registration, and commercialization of pharmaceutical products.
4. Oversee the preparation and submission of high-quality regulatory documents, including but not limited to INDs, NDAs, and BLAs.
5. Develop and maintain strong relationships with regulatory authorities to facilitate efficient and timely product approvals.
6. Stay updated on the latest regulatory developments and ensure timely implementation of changes in regulatory requirements.
7. Collaborate with internal and external stakeholders to identify potential regulatory issues and develop mitigation strategies.
8. Manage and allocate resources effectively to ensure timely completion of regulatory submissions and other projects.
9. Ensure consistency and accuracy of scientific information in all regulatory documents and communications, both internal and external.
10. Act as a mentor and coach to the team, providing guidance and support in their professional development.
11. Represent Pfizer in external forums and conferences, sharing expertise and knowledge in regulatory affairs and scientific writing.
12. Proactively identify opportunities for process improvement and implement best practices to optimize the regulatory strategy and scientific writing processes.
13. Work closely with cross-functional teams to provide regulatory input and support in product development and life-cycle management activities.
14. Maintain a thorough understanding of Pfizer's products, therapeutic areas, and business objectives to effectively contribute to the overall success of the company.
15. Adhere to Pfizer's code of conduct and ethical standards in all interactions and communications.

According to JobzMall, the average salary range for a Director, Scientific Regulatory Strategy and Scientific Writing in San Diego, CA, USA is $130,000-$150,000 per year. This can vary depending on factors such as experience, qualifications, and the specific company or organization the individual is employed by. Other factors that can affect salary include the complexity and scope of the job responsibilities, the size and industry of the company, and the individual's track record of success and achievements.

Pfizer Inc. is an American multinational pharmaceutical corporation headquartered in New York City, with its research headquarters in Groton, Connecticut. It is one of the world's largest pharmaceutical companies.