Sr. Scientist, Regulatory Affairs-CMC

Job Description

This Role is responsible for implementing CMC regulatory strategies for assigned pharmaceutical products in accordance with global regulations guidances and defined regulatory strategies as well as the preparation and review of information required for development of regulatory CMC dossiers for commercial products.

Our Regulatory Affairs team brings new medical advancements to the world by facilitating communications and procedures that allow swift organized compliance across regulatory agencies. We are an international network on the leading-edge of healthcare breakthroughs that help provide new reliable and compliant medical products practices and solutions to the world. Your role at our organization is integral to helping the world meet new breakthroughs that affect generations to come and were counting on your skills and inventiveness to help make meaningful contributions to global medical advancement.

Primary responsibilities include but are not limited to:

Regulatory Responsibilities:

• Provide input to global product and project regulatory strategies by performing assessments of CMC changes identifying global regulatory requirements and critically evaluating supporting documentation to assess acceptability and identify potential risks.
• Execute regulatory strategies by leading the development authoring and review of CMC submission components and documentation to support post-approval supplements/variations and responses to health authority questions per established business processes and systems.
• Liaise with global CMC Manufacturing Division and external partners to support compliant execution of change management and conduct all activities with an unwavering focus on regulatory conformance.
• Assess and communicate potential regulatory risks and propose mitigation strategies.
• Deliver all regulatory milestones for assigned products across the product lifecycle
• Identify and communicate potential regulatory issues to GRACS CMC management as needed

Technical Skills:

• Experience in reviewing scientific information to assess technical merits and suitability of scientific rationale to ensure information is presented clearly and conclusions are adequately supported by data.
• Demonstrated oral and written communication skills and the ability to communicate issues in a succinct and logical manner. Strong listening skills.
• Demonstrated understanding of related fields (e.g. pharmaceutical manufacturing analytical testing and quality assurance).
• Proficient computer skills and previously demonstrated ability to operate in electronic document based GMP systems

Leadership Skills:

• Demonstrated ability to generateinnovative solutions to problems and effectively work with and communicate to key stakeholders.
• Demonstrated flexibility in responding to changing priorities or dealing with unexpected events.
• Capability to handle multiple priorities and balance work to achieve business goals.
• Demonstrated effective leadership communication and interpersonal skills

Qualifications & Skills:

• Bachelors in Science Engineering or a related field (advanced degree preferred but not required). Fields of study include Pharmacy Chemical Engineering Biology Microbiology Virology Molecular Biology or Biochemistry

• Preferred (but not required): up to 5 years Pharmaceutical industry experience or up to 2 years experience in managing CMC Regulatory submissions for small molecules/vaccines/biologics. The candidate may be required to travel to other CMO sites on an as-need basis.

Required Skills:

Preferred Skills:

Current Employees apply HERE

Current Contingent Workers apply HERE

US and Puerto Rico Residents Only:

Our company is committed to inclusion ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here if you need an accommodation during the application or hiring process.

As an Equal Employment Opportunity Employer we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race color age religion sex sexual orientation gender identity national origin protected veteran status disability status or other applicable legally protected a federal contractor we comply with all affirmative action requirements for protected veterans and individuals with disabilities. For more information about personal rights under the U.S. Equal Opportunity Employment laws visit:

EEOC Know Your Rights

EEOC GINA Supplement

We are proud to be a company that embraces the value of bringing together talented and committed people with diverse experiences perspectives skills and backgrounds. The fastest way to breakthrough innovation is when people with diverse ideas broad experiences backgrounds and skills come together in an inclusive environment. We encourage our colleagues to respectfully challenge one anothers thinking and approach problems collectively.

Learn more about your rights including under California Colorado and other US State Acts

The salary range for this role is

This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. An employees position within the salary range will be based on several factors including but not limited to relevant education qualifications certifications experience skills geographic location government requirements and business or organizational needs.

The successful candidate will be eligible for annual bonus and long-term incentive if applicable.

We offer a comprehensive package of benefits. Available benefits include medical dental vision healthcare and other insurance benefits (for employee and family) retirement benefits including 401(k) paid holidays vacation and compassionate and sick days. More information about benefits is available at can apply for this role through (or via the Workday Jobs Hub if you are a current employee). The application deadline for this position is stated on this posting.

San Francisco Residents Only:We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance

Los Angeles Residents Only:We will consider for employment all qualified applicants including those with criminal histories in a manner consistent with the requirements of applicable state and local laws including the City of Los Angeles Fair Chance Initiative for Hiring Ordinance

Search Firm Representatives Please Read Carefully
Merck & Co. Inc. Rahway NJ USA also known as Merck Sharp & Dohme LLC Rahway NJ USA does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place introductions are position specific. Please no phone calls or emails.

Employee Status:

Relocation:

VISA Sponsorship:

Travel Requirements:

Flexible Work Arrangements:

Shift:

Valid Driving License:

Hazardous Material(s):

Job Posting End Date:

*A job posting is effective until 11:59:59PM on the day BEFOREthe listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.