Associate Director, Regulatory Affairs- CMC

Job Description

Our Regulatory Affairs team bring 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.

The Associate Director of Regulatory Affairs is responsible to lead a team of regulatory affairs professionals responsible for developing pre- and post-approval Chemistry, Manufacturing, and Controls (CMC) submission strategies and timelines in accordance with global regulations and guidance as well as the preparation and maintenance of the CMC dossiers for new and in-line Animal Health pharmaceutical products throughout the world.

Responsibilities:
  • Hire staff; ensure training; establish ongoing responsibilities and annual objectives; monitor performance and provide ongoing feedback; conduct routine individual and group staff meetings; and perform year-end activities consistent with our Company's processes
  • Collaborate cross-functionally with manufacturing, quality, technical support, R&D, and marketing; direct the CMC team efforts to ensure all important CMC submission milestones are met; support the CMC team members to work effectively with other functions to develop robust regulatory strategies and high-quality regulatory submissions
  • Critically review key CMC submissions
  • Support the development and maintenance of standard processes and systems to maintain regulatory information to support regulatory compliance. This may involve leading complex projects related to these processes or systems.
  • Maintain and foster current in depth knowledge and experience applying the EMA, FDA, VICH, and other country specific CMC/Quality related guidelines to pre- and post-approval CMC submissions.
  • Facilitate and participate in meetings and/or inspections with the regulatory authorities on behalf of the company; in particular, act as a liaison with FDA-CVM on regulatory CMC related topics.
  • Identify and communicate potential regulatory issues to management, as needed.


Education:
  • Bachelor of Science degree in science, engineering, or other relevant field (advanced degree preferred)


Experience:
  • 10 years pharmaceutical experience with at least 5 years in CMC
  • Experience preparing successful post approval global variations for active substance changes is required
  • Project management skills are required
  • Supervisory experience is required


Preferences:
  • Experience critically reviewing detailed scientific information to ensure information is presented clearly and conclusions are supported by data
  • Strong understanding of related fields (manufacturing, analytical, quality assurance, and R&D).
  • Strong written and verbal communication skills in multicultural settings and ability to communicate in a succinct, logical manner
  • Good listener
  • Able to solve complex problems and work with and communicate to key stakeholders
  • Able to deal with changing priorities or unexpected events
  • Strong leadership and interpersonal skills
  • High level of professionalism
  • Additional language skills are a plus


Our Animal Health Division is a trusted global leader in veterinary medicine, dedicated to preserving and improving health, well-being, and performance of animals and the people who care for them. We are a global team of professionals working together to make a positive difference in animal care and the world's food supply and have a deep sense of responsibility towards our customers, consumers, animals, society, and our planet.

Through our commitment to The Science of Healthier Animals®, we offer veterinarians, farmers, pet owners and governments one of the widest ranges of veterinary pharmaceuticals, vaccines and health management solutions and services as well as an extensive suite of digitally connected identification, traceability and monitoring products. We invest in dynamic and comprehensive R&D resources and a modern, global supply chain. We are present in more than 50 countries, while our products are available in some 150 markets.

Who we are ...

We are known as Merck & Co., Inc., Kenilworth, New Jersey, USA in the United States and Canada and MSD everywhere else. For more than a century, we have been inventing for life, bringing forward medicines and vaccines for many of the world's most challenging diseases. Today, our company continues to be at the forefront of research to deliver innovative health solutions and advance the prevention and treatment of diseases that threaten people and animals around the world.

What we look for ...

Imagine getting up in the morning for a job as important as helping to save and improve lives around the world. Here, you have that opportunity. You can put your empathy, creativity, digital mastery, or scientific genius to work in collaboration with a diverse group of colleagues who pursue and bring hope to countless people who are battling some of the most challenging diseases of our time. Our team is constantly evolving, so if you are among the intellectually curious, join us—and start making your impact today.

NOTICE FOR INTERNAL APPLICANTS

In accordance with Managers' Policy - Job Posting and Employee Placement, all employees subject to this policy are required to have a minimum of twelve (12) months of service in current position prior to applying for open positions.

If you have been offered a separation benefits package, but have not yet reached your separation date and are offered a position within the salary and geographical parameters as set forth in the Summary Plan Description (SPD) of your separation package, then you are no longer eligible for your separation benefits package. To discuss in more detail, please contact your HRBP or Talent Acquisition Advisor.

Residents of Colorado

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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.

For more information about personal rights under Equal Employment Opportunity, visit:

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We are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another's thinking and approach problems collectively. We are an equal opportunity employer, committed to fostering an inclusive and diverse workplace.

Search Firm Representatives Please Read Carefully
Merck & Co., Inc., Kenilworth, NJ, USA, also known as Merck Sharp & Dohme Corp., Kenilworth, 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:
Regular

Relocation:
No relocation

VISA Sponsorship:
No

Travel Requirements:
10%

Flexible Work Arrangements:
Flex Time

Shift:
1st - Day

Valid Driving License:
No

Hazardous Material(s):

Number of Openings:
1

Requisition ID:R131675