Associate Director Regulatory Liaison - Oncology

MSD Malaysia; North Wales (Montgomery County); Hybrid; USD 129,000 - 203,000; Full time

Benefits offered by this job

Medical, dental, vision benefits

401(k) retirement plan

Paid holidays

Vacation

Sick days

Job summary

Merck & Co., Inc. seeks an Associate Director, Regulatory Affairs to support Oncology products within a regulatory team.

You will work with global regulatory leads to help develop and implement a global strategy for registration and maintenance of products. You will assist with submissions, strategy documents, and cross-functional collaboration to ensure compliant, timely regulatory outcomes across markets.

Qualifications

• Experience in drug development and regulatory submissions.
• Strong communication and collaboration across global teams.
• Proven ability to manage complex regulatory strategies for oncology products.
• Ability to interpret regulatory guidance and competitive intelligence.
• Experience with global regulatory agencies and submissions.

Responsibilities

• Assist in regulatory agency communications and submissions across markets.
• Draft, shepherd and review responses to Agency requests and background packages.
• Support development of global regulatory strategy and lifecycle management.
• Collaborate with Regulatory Operations, Clinical Safety, Labeling, and CMC teams.
• Contribute to process improvements and regulatory administrative activities.

Skills

Drug development experience

Regulatory submissions

Cross-functional collaboration

Excellent communication

Global regulatory strategy

Education

Bachelor’s Degree

Master’s Degree

MD/PhD or related doctoral degree

Job description

Job Description The Associate Director, Regulatory Affairs, supports products in the Oncology therapeutic area as part of a regulatory team. The individual will have excellent communication and collaboration skills and will work closely with a global regulatory lead(s) to help develop and implement a global strategy for registration and/or maintenance of products. Responsibilities may encompass all aspects of planning and implementation of a global regulatory strategy and regulatory submissions including assisting in preparing submissions, protocol review, and conducting research on regulatory guidance's or competitive intelligence. The individual will have responsibility for driving results for his/her assigned projects through application of regulatory science and strong communication and analytical skills. Our Regulatory Affairs team bring new medical advancements to the world by facilitating communications and procedures that allow swift, organized compliance partnering with external regulatory agencies. We are on the leading-edge of healthcare breakthroughs that help provide new, reliable, and compliant medical products, practices and solutions to the world.

Primary Responsibilities

Assisting in Regulatory Agency communications and submissions, including marketing applications, investigational new drug (IND) applications, pediatric plans and annual or other periodic reports. The individual may also assist or take the lead in tracking, authoring, shepherding and/or review of responses to Agency requests. Implementing strategy to develop Agency background packages and documents associated with regulatory submissions for marketing applications. Communicating with Agencies and attending Agency meetings as needed to assist the global regulatory lead. Participating as an active member on the global regulatory team. Individual will attend cross-functional meetings as required, in collaboration with, and to assist the global regulatory lead. Conducting research and review of guidelines, regulatory precedence and competitive intelligence to facilitate development of regulatory strategy. Assist the global regulatory lead in authoring of regulatory strategy documents. Collaborating and communicating regulatory strategy as needed to colleagues in Regulatory Operations, Clinical Safety, Labeling, Regulatory Chemistry, Manufacturing and Control (CMC) as well as other functional areas (e.g., clinical research, non-clinical safety assessment). Support maintenance (e.g., quality compliance and life cycle management) of oncology programs. Support of global regulatory lead in label development. Assisting with process improvement initiative. Performing regulatory administrative activities, as needed.

Education Minimum Requirements

• Bachelor’s Degree, with at least 5 years of relevant experience in the pharmaceutical industry.
• Master’s Degree with at least 2 years of relevant experience in pharmaceutical industry.
• M.D. or Ph.D. or other related doctoral degree in biological science, chemistry or related discipline with relevant experience.

Required Experience and Skills

• Experience in drug development
• Prior regulatory experience interacting with a major regulatory agency
• Excellent communication skills (both oral and written).
• Good organizational skills with a proven ability to simultaneously balance diverse activities for multiple projects.
• Flexibility required.
• Strong scientific and analytical skills with attention to detail.

Preferred Experience and Skills

• Experience with oncology products is highly preferred #EligibleforERP

Preferred Skills

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. 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 characteristics. As 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 another’s 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 $129,000.00 - $203,100.00 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 employee’s 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.

• medical, dental, vision healthcare and other insurance benefits (for employee and family)
• retirement benefits, including 401(k)
• paid holidays
• vacation
• compassionate and sick days

More information about benefits is available at https://jobs.merck.com/us/en/compensation-and-benefits.

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: Regular

Relocation: No relocation

VISA Sponsorship: No

Travel Requirements: 10%

Flexible Work Arrangements: Hybrid

Shift: Not Indicated

Valid Driving License: No

Hazardous Material(s): n/a

Our company is a global health care leader with a diversified portfolio of prescription medicines, vaccines and animal health products. The difference between potential and achievement lies in the spark that fuels innovation and inventiveness; this is the space where we have codified our legacy for over a century.

Our success is backed by ethical integrity, forward momentum, and an inspiring mission to achieve new milestones in global healthcare.