Regulatory Strategy Senior Director

Work Schedule

Environmental Conditions

Job Description

At Thermo Fisher Scientific youll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life - enabling our customers to make the world healthier cleaner and safer. We provide our teams with the resources needed to achieve individual career goals while taking science a step beyond through research development and delivery of life-changing therapies. With clinical trials conducted in 100 countries and ongoing development of novel frameworks for clinical research through our PPD clinical research portfolio our work spans laboratory digital and decentralized clinical trial services. Your determination to deliver quality and accuracy will improve health outcomes that people and communities depend on now and in the future.

About the role:

TheSr Director Regulatory Strategywill be responsible for advising clients on strategic regulatory considerations for investigational products including:

• Defining regulatory pathways and strategies for optimized product development
• Acting as a regulatory strategy leader and Subject Matter Expert (SME) work with cross functional teams to chip in to the development of target product profiles strategic program assessments clinical development plans and integrated development plans delivering on Thermo Fishers Accelerator Drug Development solutions.
• Defining essential regulatory achievements and central messaging to assist in acquiring approval for investigational and marketing applications with regulatory agencies
• Providing strategic regulatory oversight across programs and portfolios
• Providing strategic regulatory oversight of regulatory interactions such as scheduled meetings (e.g. Interact pre-IND type B C D meetings as well as regulatory submissions such as IND NDA and BLA)
• Work on problems of diverse scope where analysis of data requires in-depth evaluation of identifiable factors.
• Provide senior level strategic direction to the PPD Strategic Development Consulting team on ways to optimize work processes for delivering Consulting services and creating new client offerings
• Providing and facilitating an expert level interface between regulatory agencies and client
• Representing the Strategic Development Consulting group in discussions with clients and establishing relationships.
• Engage in and support the Strategic Regulatory Consulting team and its development and growth.
• Take an active role in business development to expand the portfolio of both standalone regulatory and cross functional consulting projects.
• Participate in and implement thought leadership initiatives that support and showcase Strategic Regulatory Consulting and the broader organization.
• Maintenance of up-to-date knowledge and understanding of PPD SOPs relevant client SOPs/directives and current regulatory guidelines as applicable to services provided.

Qualifications

Requirements:

• Advanced degree (PhD PharmD MD MS) in a science related field (Chemistry Cellular or Molecular Biology Pharmaceutics or Process Engineering) preferred.
• At least 10 years of Product Development/Strategic Regulatory Experience in the pharmaceutical industry with a demonstrable record of career advancement and drug development accomplishments
• Significant knowledge of and experience with US regulatory requirements with a proven track record for successful negotiations with Health Authorities. Wider global regulatory knowledge is an advantage.
• Ability to lead multiple projects co-ordinate with Subject Matter Experts and lead discussions with clients.
• Demonstrated understanding of the entire drug development process is required.
• Experience as a consultant is strongly preferred.
• Excellent communication and interpersonal skills and a track record of working effectively in matrixed teams.

In some cases an equivalency consisting of a combination of appropriate education training and/or directly related experience will be considered sufficient for an individual to meet the requirements of the role.

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 100000 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 with PPD part of Thermo Fisher Scientific where diverse experiences backgrounds and perspectives are valued.

Apply today!

Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race color religion sex sexual orientation gender identity national origin protected veteran status disability or any other legally protected status.

Compensation and Benefits

This position may also be eligible to receive a variable annual bonus based on company team and/or individual performance results in accordance with company policy. We offer a comprehensive Total Rewards package that our U.S. colleagues and their families can count on which includes:

• A choice of national medical and dental plans and a national vision plan including health incentive programs

• Employee assistance and family support programs including commuter benefits and tuition reimbursement

• At least 120 hours paid time off (PTO) 10 paid holidays annually paid parental leave (3 weeks for bonding and 8 weeks for caregiver leave) accident and life insurance and short- and long-term disability in accordance with company policy

• Retirement and savings programs such as our competitive 401(k) U.S. retirement savings plan

• Employees Stock Purchase Plan (ESPP) offers eligible colleagues the opportunity to purchase company stock at a discount

For more information on our benefits please visit: Experience:

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