Associate II- Reg CMC Strategy, SI LCM

the team to quickly mitigate the risks.

• Works under supervision.

• Performs all assignments using established procedures and general instructions on the process.

• Remains knowledgeable about current regulations / guidelines and correlates in the assigned projects.

QUALIFICATIONS / SKILLS

• Preferred Education:

Bachelors or Master in Science / Pharmacy

• Preferred Experience:

Minimum 3 Years in working independently in the Regulatory Affairs function in a reputed Pharmaceutical Organization with major experience in handling post approval changes to health authorities.

• Preferred Attributes:

Good English communication skills (both verbal and written). Good interpersonal and negotiation skills.

Good conceptual and reasoning skills. Attention to details.

• Technical Skills:

o Regulatory requirements of post approval changes for various global regulatory agencies especially

USFDA and EMA & other EU health Authorities.

o Sound understanding ICH Quality Guidelines.

o Sterile injectable manufacturing and regulatory data requirements for submission.

o Knowledge on general standards, processes and policies of Pharmaceutical Industry.

Work Location Assignment: Flexible

Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.

Regulatory Affairs