Reg Affairs CMC Senior Specialist - Regional ( x 3 roles)
Reg Affairs CMC Senior Specialist - Regional ( x 3 roles)-REG002324
MSD is a global health care leader with a diversified portfolio of prescription medicines, vaccines and animal health products. Today, we are building a new kind of healthcare company – one that is ready to help create a healthier future for all of us.
Our ability to excel depends on the integrity, knowledge, imagination, skill, diversity and teamwork of an individual like you. To this end, we strive to create an environment of mutual respect, encouragement and teamwork. As part of our global team, you’ll have the opportunity to collaborate with talented and dedicated colleagues while developing and expanding your career.
MSD’s research laboratories have a number of newly created opportunities for an experienced Regulatory CMC Associates to join our EEMEA Regional team. We are building our CMC hub in the UK, however there is flexibility as to where candidates can be based in Europe.
The candidate will be responsible for development of regional CMC strategy, preparation of CMC documentation and execution of regional post-approval CMC supplements and new product registrations for all MSD products, serving as a link between with local Affiliate Drug Regulatory Affairs (DRA) team requirements and global CMC strategy to ensure right first-time submissions to Health Authorities.
The Regulatory CMC Regional Hub is a key component of MSD’s strategy to build regional regulatory knowledge, effective local relationships with MSD country offices in order to deliver appropriate regulatory strategies and right first time regulatory submissions and support conformance of MSDs manufacturing practices with registered details.
Appointment to this position will be on local salary and benefits package.
The incumbent will be accountable for implementing regional CMC strategy for international markets for post-approval CMC supplements and new product submissions with a focus on achieving right-first-time submissions including the following activities:
- Coordination of regulatory change assessments from local countries within the region and documentation within CMC change management electronic systems
- Prioritisation of execution of submissions as per global regulatory strategy and in coordination with local affiliates to ensure regulatory conformance.
- Seeking opportunities to maximize submission efficiency and quality to ensure a high rate of submission approvals by Health Authorities.
- Tracking of submission and approvals, and ensuring bidirectional communication of status with local and global CMC teams.
- Preparation of submission documentation by modification and consolidation of global documentation for local submissions according to local/regional requirements, and in consultation with subject matter experts in global CMC and local countries.
- Preparation of timely responses to Health Authority questions resulting from post-approval or new product submissions in regional markets under responsibility.
- Ensuring submissions are prepared in alignment with Health Authority commitments as result of license/dossier approval.
- Representing regional CMC strategy on cross-functional teams to ensure mutual understanding of local/regional CMC requirements and program complexities, and maintaining close communication with regional and local Affiliate DRAs, regional Supply Chain teams, global CMC product leads and the Regulatory network.
- Ensuring awareness of regional regulatory policy trends and maintaining the regulatory intelligence repository for regional markets under responsibility.
- The candidate may be required to travel to other company sites on a periodic basis.
- The candidate must possess a degree (or equivalent qualifications/experience) in science with a minimum of 4 years of experience in the pharmaceutical industry.
- The ideal candidate will have experience in Regulatory Affairs for the regional markets, with a focus on Regulatory CMC requirements for small molecule/biologic products, development, manufacturing and/or quality assurance.
- He/she will demonstrate effective problem solving, understanding of regulatory strategies, excellent interpersonal skills, detail oriented, and able to prioritise multiple tasks.
- Must have a proven ability to communicate effectively in both a written and verbal format. The ideal candidate will be fluent in 1-2 European languages, in addition to English.
- Ability to influence and work both independently and collaboratively in a team structure.
- Proven ability to work well under pressure.
Our employees are the key to our company’s success. We demonstrate our commitment to our employees by offering a competitive and valuable rewards program. Our Company’s benefits are designed to support the wide range of goals, needs and lifestyles of our employees, and many of the people that matter the most in their lives.
Recruitment Agency / Search Firm representatives please note:
MSD will not accept unsolicited CVs from recruitment agencies / search firms under any circumstances. In order to present CVs to MSD, your Recruitment Agency / Search Firm will have been invited to work on a specific vacancy and have Terms of Business signed and agreed with the relevant Recruitment and Staffing Regional Lead. Should you send CVs for a vacancy that you have not been specifically invited to work on to any employee at MSD (via email, post, internet, Taleo or any other method), these will be deemed the sole property of MSD. MSD will pay no introduction fee to the Recruitment Agency / Search Firm if a candidate is hired as a result of an agency introduction under these circumstances.
Job: Regulatory Affairs - CMC Job Title:Reg Affairs CMC Senior Specialist - Regional ( x 3 roles)
Primary Location: EMEA-United Kingdom-ENG-Hoddesdon
Other Locations: EMEA-Belgium, EMEA-Netherlands-NB-Boxmeer, EMEA-Switzerland, EMEA-Croatia, EMEA-France, EMEA-Italy, EMEA-Belgium-Luxembourg, EMEA-Hungary, EMEA-Slovenia, EMEA-France-J-Courbevoie, EMEA-Sweden, EMEA-Netherlands-NB-Oss, EMEA-Greece, EMEA-Serbia, EMEA-Austria, EMEA-Romania-Bucuresti-Bucharest, EMEA-Czech Republic, EMEA-Lithuania, EMEA-Spain, EMEA-Portugal, EMEA-Bulgaria, EMEA-Netherlands-NH-Haarlem, EMEA-Slovakia, EMEA-Germany, EMEA-Denmark, EMEA-Poland-Mazowieckie-Warsaw, EMEA-Norway, EMEA-Ireland
Employee Status: Regular
Travel: Yes, 10 % of the Time
Number of Openings: 1
Company Trade Name:MSD