Assistant Manager – Submission Publishing

Thornton Tomasetti; Mumbai; On-site; INR 800,000 - 1,100,000; Full time

Job summary

Abbott in Mumbai is seeking an experienced Regulatory Affairs professional to work under limited supervision and apply deep regulatory knowledge to guide product registration submissions, progress reports, supplements, and lifecycle activities.

You will interact with regulatory authorities to expedite approvals and serve as the regulatory liaison to marketing and research teams, advising on labeling, regulatory strategy, and manufacturing changes to ensure timely market access.

Qualifications

• Associates degree in a related field.
• Minimum 1 year of regulatory affairs experience.
• Experience with drug, biologic or medical device regulation is a plus.

Responsibilities

• Direct development of product registration submissions, progress reports, supplements or amendments.
• Interact with regulatory agencies to expedite approvals.
• Serve as regulatory liaison throughout the product lifecycle.
• Advise development/marketing teams on manufacturing changes, labeling and regulatory interpretations.

Skills

Regulatory affairs knowledge

Communication skills

Cross-functional collaboration

Education

Associates Degree

Job description

JOB DESCRIPTION: MAIN PURPOSE OF THE ROLE

Experienced professional individual contributor that works under limited supervision. Applies subject matter knowledge in the area of Regulatory Affairs. Requires capacity to apply skills/knowledge within the context of specific needs or requirements.

MAIN RESPONSIBILITIES

• As the Experienced professional in the Regulatory Affairs Sub-Function, possesses well developed skills in directing development of product registration submission, progress reports, supplements, amendments, or periodic experience reports.
• Interacts with regulatory agency to expedite approval of pending registration.
• Serves as regulatory liaison throughout product lifecycle.
• Participates in some of the following: product plan development and implementation, regulatory strategy, risk management, chemistry manufacturing control (CMC).
• Ensures timely approval of new drugs, biologics or medical devices and continued approval of marketed products.
• Serves as regulatory representative to marketing, research teams and regulatory agencies.
• Advises development and/or marketing teams on manufacturing changes, line extensions, technical labeling, appropriate regulations and interpretations.

QUALIFICATIONS

Education Level: Major/Field of Study or Equivalent: Associates Degree (± 13 years)

Experience: Minimum 1 year

The base pay for this position is N/A. In specific locations, the pay range may vary from the range posted.

JOB FAMILY: Regulatory Operations

DIVISION: EPD Established Pharma

LOCATION: India > Mumbai: BKC Building

ADDITIONAL LOCATIONS:

WORK SHIFT: Standard

TRAVEL: Not specified

MEDICAL SURVEILLANCE: Not Applicable

SIGNIFICANT WORK ACTIVITIES: Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day)

Abbott is about the power of health. For more than 135 years, Abbott has been helping people reach their potential — because better health allows people and communities to achieve more. With a diverse, global network serving customers in more than 160 countries, we create new solutions — across the spectrum of health, around the world, for all stages of life. Whether it’s next-generation diagnostics, life-changing devices, science-based nutrition, or novel reformulations, we are advancing some of the most innovative and revolutionary technologies in healthcare, helping people live their best lives through better health. The people of Abbott come to work each day with relentless energy, enthusiasm and a promise to enhance the health and well-being of millions of people. They push the boundaries to help manage and treat some of life’s greatest health challenges.

An equal opportunity employer, Abbott welcomes and encourages diversity in our workforce.