Associate Director Global Regulatory Affairs Pharma Safety & Efficacy, New developments M/F/D

Job Description

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.

MAJOR ACTIVITIES AND RESPONSIBILITIES:

Provide comprehensive regulatory input (Focus: Pharmaceuticals, Safety and Efficacy) during early and late development to support risk identification and mitigation

Prepare regulatory filing strategies for EU and global submissions (excl US) to optimize time-to-market and market access (global roll-out)

Coordinate, critically review, and manage all safety, efficacy, and regulatory documentation to ensure alignment with target profile and regulatory compliance for EU and key markets

Prepare and manage regulatory submissions, including meetings with and responses to health authority questions to ensure timely approval

Work closely with regional and local regulatory teams to ensure local regulatory compliance

Enter and maintain regulatory information in accordance with processes and procedures to support regulatory compliance

Continuous surveillance of new regulatory guidance, changes in regulatory framework relevant to the company’s development pipeline

Active participation in working groups and panels of relevant industry and regulatory associations

REQUIREMENTS & CORE Compentencies:

University degree in Veterinary Medicine

Several years of experience in pharma product development

Proven experience with EU submissions and authority meetings

Profound expertise in technical & procedural regulatory requirements

Proven ability to coordinate multiple projects and priorities and meeting critical deadlines

Proven ability to deal with multiple priorities, strong interpersonal skills, sound judgement and attentive to details

Strong and effective communicator and negotiator with internal and external contacts

Proficient in English, German would be a plus

People with severe disabilities and their equivalents will be given preference if they are equally qualified.

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.

Required Skills:

Adaptability, Change Management, Cross-Cultural Awareness, Data Management, Employee Training Programs, FDA Regulations, Pharmacovigilance, Policy Implementation, Regulatory Compliance, Regulatory Labeling, Regulatory Operations, Regulatory Submissions, Strategic Thinking, Systems Development Lifecycle (SDLC), Vendor Management

Preferred Skills:

Current Employees apply

HERE

Current Contingent Workers apply

HERE

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