Sr Manager, Regulatory Affairs

at  Thermo Fisher Scientific

JOB DESCRIPTION

As part of the Thermo Fisher Scientific team, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life every single day to enable our customers to make the world healthier, cleaner and safer. We provide our global teams with the resources needed to achieve individual career goals while helping to take science a step beyond by developing solutions for some of the world’s toughest challenges, like protecting the environment, making sure our food is safe or helping find cures for cancer.

EDUCATION

• Bachelor’s degree in science, pharmacy or related field required.

EXPERIENCE

• Minimum of 8 years related experience in the pharmaceutical industry or advanced degree with 6 years related experience.
• 2 years’ leading a team

KNOWLEDGE, SKILLS, ABILITIES

• Extensive knowledge of regulatory requirements, and their impact the product development process.
• Ability to evaluate and analyze potential regulatory impact on new and existing products and provide strategic recommendations to minimize risks and ensure compliance.
• Extensive experience in compiling and submitting regulatory filings: Possess a track record of leading successful complex regulatory filings.
• Demonstrated ability to navigate regulatory authorities’ requirements and effectively communicate with them to ensure timely and accurate submissions.
• Exhibit excellent communication skills to effectively interact with internal customers, regulatory authorities, and cross-functional teams.
• Clearly convey sophisticated regulatory concepts, strategies, and requirements in a concise and persuasive manner. Strong presentation skills are also necessary to engage and influence key decision-makers.
• Demonstrated advanced organizational and time management skills to efficiently prioritize and manage multiple complex projects simultaneously. Possess the ability to allocate resources effectively, set realistic deadlines, and adapt to changing priorities while maintaining high productivity and quality standards.
• Seasoned people leader who builds a positive workplace that promotes partnership, collaboration, and innovation

PHYSICAL REQUIREMENTS / WORK ENVIRONMENT

• Regular interaction with cross-functional teams, such as Research and Development, Product Management, Marketing, Quality Assurance, and Manufacturing.
• Interaction with Regulatory authorities.
  We offer competitive remuneration, annual incentive plan bonus, healthcare, and a range of employee benefits. Thermo Fisher Scientific offers employment with an innovative, forward-thinking organization, and outstanding career and development prospects. We offer an exciting company culture that stands for integrity, intensity, involvement, and innovation!
  Our Mission is to enable our customers to make the world healthier, cleaner and safer. Watch as our colleagues explain 5 reasons to work with us. As one team of 100,000+ colleagues, we share a common set of values - Integrity, Intensity, Innovation and Involvement - working together to accelerate research, solve complex scientific challenges, drive technological innovation and support patients in need. #StartYourStory at Thermo Fisher Scientific, where diverse experiences, backgrounds and perspectives are valued.

Please refer the Job description for details